Clinical Data Management solution for Choice Pharma
A full-service Contract Research Organisation (CRO), Choice Pharma is one of the fastest-growing CROs in the Asia-Pacific region. But as patient numbers increased, Choice Pharma realised that it needed to manage clinical trials more effectively in order to consolidate its success. The company turned to NNIT for help.NNIT analysed Choice Pharma’s operational and strategic pains and delivered reports for the client’s program execution,
focus area and budget plan. NNIT then provided a full validation package and training courses to support Choice Pharma’s globalised clinical trials in compliance with CDISC standard. With CDISC (CDASH, SDTM) requirements fulfilled, Choice Pharma is now well on the way to achieving its targets in AsiaPacific. Reusable resources are synchronised in a Global Library and staff across the region have immediate access to data when they need it.
Fast growth presented Choice Pharma with a challenge. Patient numbers rose from 4,500 to 26,000 in just one year,
and the company needed a data management system that could cope with the sharp increase in data volume from clinical trials. In particular, the company wanted to develop a solution that would enable it to utilise historical information to improve clinical development programmes, support marketing and help answer questions from the authorities. The solution also had to be flexible enough to support the use of data across functional areas in a global organisation.
In addition, Choice Pharma needed to identify and implement prerequisites in its management systems.
“There are certainly many benefits from conducting clinical trials in Asia,” explains Chris Wang, Managing Director at Choice Pharma, “but understanding these advantages demands uncompromising standards for data management.”
NNIT used its industry experience to map out Choice Pharma’s complete drug development process on an as-is level.
The NNIT team then analysed Choice Pharma’s operational and strategic pains and produced reports on programme
execution, focus areas and budgeting.
Choice Pharma had already implemented Oracle Clinical, an integrated Clinical Data Management (CDM) and Remote Data
Capture (RDC) application. However, the system needed to be validated. NNIT provided a full validation package,
including training courses, to ensure the company’s globalised clinical trials comply with the CDISC standard.
The LSH-pre-oriented solution ensures Choice Pharma has access to accurate and timely information, while the integrated
clinical data environment enables Choice Pharma to make better-informed decisions.
Henry Liu, NNIT’s Project Manager, explains:
“All data is automatically standardised to international standards. This is a great benefit. It means that the data is now consolidated and available for crossstudy analysis – and the client can quickly answer queries from regulatory bodies.”
Thanks to its understanding of pharmaceutical standards and processes, NNIT was able to develop a solution that
enables Choice Pharma to increase its return on investment. The easy-to-use and scalable system makes managing
clinical data simpler and reduces the amount of time Choice Pharma spends on managing clinical trial documents.
By ensuring all trials data is managed to the CDISC standard, Choice Pharma is far better placed to achieve its globalisation targets. Also, as all re-usable resources are synchronised in a Global Library, the company can capture and track archives with minimum effort across its locations worldwide.“NNIT’s solution gives us ‘simple’ and efficient data management and furthermore sets us up for success on the bottom line,” says Cynthia Chang, Senior Manager of Choice Pharma.
In addition, the solution provides very specific benefits for staff on a daily basis. This includes:
• Reducing the frequency of monitoring visits
• Reducing queries and discrepancies
• Increasing monitoring efficiency
• Enabling real-time data capture
• Reducing protocol violations
• Providing consistency of source documentation across all sites
• Providing seamless transmission to backend data systems
• Maintaining the familiar look and feel of paper
• Allowing more subjects to be processed per day
• Providing automatic calculations for data points such as BMI
• Eliminating the majority of data entry errors and discrepancies
• Reducing the invalid enrolment of participants
• Establishing an HIPAA and 21 CFR Part 11 compliant audit trail
• Minimising time lost to training and troubleshooting problems
• Freeing sites from having to develop their own source documentation
• Providing secure and accessible storage
About Choice Pharma
Choice Pharma is an international contract research organisation established in the UK in 1998. Today, the company’s expertise is focused on the management of clinical trials across Asia-Pacific. With six operational offices, Choice Pharma is one of the fastest-growing CROs in the region. And, as part of ChoiceOne group, Choice Pharma also has global business
support and project management capabilities in the USA, the UK, Switzerland and Dubai.
Clinical Data Warehouse for major pharmaceutical company
As a leading manufacturer of pharmaceuticals, our client needed an efficient system for exchanging and storing clinical data. Our client also needed to standardise data in order to be exchanged with external partners in a structured, meaningful way. Standardised data would also speed up the approval process with the FDA, enabling our client to get products to market faster. A clinical data warehouse from NNIT was the answer. Based on Oracle’s Life Sciences Data Hub (LSH), NNIT’s clinical data warehouse provided the client with the right tools and infrastructure to perform cross-study analyses, be in compliance with regulatory authorities – and grow its business.
When the client came to NNIT, data from each clinical trial was stored in separate databases. The process began with a
physician entering data electronically or manually. Data was then transferred to a clinical database, and checked before
moving on to the results process. As a consequence, data from various trials was scattered across the organisation,
and it didn’t necessarily meet international standards. In general the system wasn’t sufficient and posed several
problems for our client.
As a growing business, the client didn’t have the resources to run all the data trials it was planning. Furthermore reusing
existing data and accessing the information inside the data was not possible. This made it difficult to exchange data
with partners, and it made product acquirements and selling off of the portfolio challenging. The client needed a standardised storage facility for data and the information in the warehouse needed to match the standards set by the FDA. In order to keep one step ahead it was crucial to anticipate what the FDA would look for and to be able to review the data just like the FDA would.
According to Senior NNIT Project Manager Philip Puls, NNIT was brought in early in the process because the client knew NNIT had the right experience with clinical data warehouses. Says Philip Puls, “They invited us because we understood their specific requirements and needs – and we had the ability to implement the right solution in collaboration with them. They couldn’t find this knowledge anywhere else.” NNIT conducted an initial analysis and helped the client structure the selection process from software and vendors. Then, working closely with the client, NNIT produced a clinical data warehouse that was more than just a repository for data; it was also a system for harmonising, standardising and making efficient use of all trial data. Based on Oracle’s LSH database and a customised component developed by NNIT for the pharmaceutical industry, NNIT’s clinical data warehouse solution ensured the client complied with industry standards.
The LSH-based solution from NNIT offers accurate and timely information, providing the organisation with an integrated
environment for clinical data and the ability to make better decisions. NNIT’s Business Integration Leader is pleased with the solution: “All data is automatically standardised to international standards. This is a great benefit. It means that the data is now consolidated and available for cross-study analysis – and the client can quickly answer queries from regulatory bodies.”
NNIT’s clinical data warehouse was delivered on time and on budget. Now the client has a single repository for all
data from all clinical trials, and the data is guaranteed to meet CDISC (Clinical Data Interchange Standards Consortium)
international standards. And by ensuring data is structured in a way that meets FDA standards, the client can move faster through the approval process, reducing the time and the costs involved in the approval. Also, because the data processes in the warehouse are streamlined, the client experiences long-term efficiency gains. The implementation project is now complete, but a few NNIT people are still involved on a day-to-day basis in support functions. And the successful partnership is continuing. NNIT and the client have a series of new projects in the pipeline, and the client may wish to expand the functionality of the clinical data warehouse in the future – if so, NNIT will be there to help.
Clinical Trial Management system implementation for Protech Pharmaservices Corporation (PPC)
As a prestigious CRO of Taiwan with affiliates around Asia, PPC is dedicated to serving the pharmaceutical and biotechnology industry with a costeffective, safe and high-standard quality for clinical and non-clinical drug development, shortening the lead time to market. With the increasing demand of a fast efficiency of IT performance, higher requirements from customers for a better management of the system, PPC leadership decided to implement a clinical trial management system.
As an IT company rooted from Novo Nordisk, NNIT knows more about life science companies than the IT industry.
Based on this and after an in-depth investigation and analysis, PPC finally concluded that NNIT’s solution is the best
to optimise the operation system. In the long run, PPC expects to see improved process efficiency, a better trial quality and lower trial costs from the implementation.
After a thorough analysis and a series of activities for PPC’s IT platform, NNIT has defined its IT challenges and barriers
clearly and has recommended solutions to manage them. In the present state, PPC’s information island is still discrete and
isolated with trials running in different teams, which have greatly lowered its efficiency.
Besides that, PPC needs close communication with sponsors to provide the desired documents on time, and within
budget. PPC is still facing slow feedback sometimes upon a sponsor’s request of a report. The lacks of a complete overview of the status of the trials in general as well as the management of assets history are still among the main concerns for their future development.
The acceleration solution was created based upon the clinical business process and business user requirements developed
by industry experts. By using these documents we are able to identify the processes that a CTMS should support and work towards to optimise the functionality of these areas.
According to PPC’s current problems and status, NNIT has created a customised solution of CTMS. With the strength of
clinical focus, project intelligence, and cost benefit, CTMS has optimised its IT functionality and improved the process
efficiency greatly. CTMS provides an application implementation and training solution as opposed to a full system
development lifecycle. It has been created to provide all of the items necessary to achieve a successful implementation in
the minimal amount of time. To address the current issues of PPC, NNIT has built up a centralised platform to collect project information which has facilitated all relevant staff to get easy access to relevant information. According to the actual business operation, we have created easy query and reporting functionality, reusable resource for process
planning and visit design, efficient electronically based trial data collecting, and real time online access to sponsors for
data analysis. NNIT also provides a comprehensive solution capable of managing information and processes from EDC, CDMS, adverse event reporting systems, and IVRS, etc.
So what’s the result? NNIT’s CTMS Solution has realized a 50-85% reduction in implementation costs as compared to
standard consultation services. How does the solution work? NNIT has enabled easy transition from paper-based,
legacy clinical trial methods to all-electronic, Internet-enabled solutions and the CTMS architecture scales not only for
enterprise growth but also to accommodate multiple trials. Just as PPC expected, the time and cost of clinical process are
greatly reduced. The implementation of CTMS has helped PPC improve the productivity and throughput of clinical operations and has helped the planning and scheduling process within clinical trials, also improving analytical
abilities with the clinical data. With regard to information, the new system has served as a centralised repository for all investigators to collect and track relevant information about research, including personal profiles to disease specialties. Information will be readily available to manage clinical trials at different tiers – local, regional and global.
This new solution has improved the IT ability to closely monitor the financial activity between the enterprise and its
respective investigators, and offered a consistent view of the clinical trials undertaken by the customer and provide up to
date information on clinical trial statuses across the organization. The common platform, which NNIT has customised for
PPC, will assist the customer in conducting their activities to achieve operational efficiency. Plans are underway to integrate Siebel Clinical with the customer’s finance system. This will help streamline the business and support for real time and accurate reporting, enabling traceability and auditability, and helping reduce the risk of errors due to manually entered information.
According to our regular customer’s feedback – PPC scores us 5 which is the highest score. The customer is satisfied with both the result of the project and the performance of NNIT project delivery team.
PPC is one of the prestigious CRO grew up in Taiwan with local affiliates around the AsiaPacific region in Japan, China, Hong Kong, Singapore and Australia for Asian Study. The company mission is to continuously dedicate to serving the pharmaceutical and biotechnology industry with costeffective, safe and high standard quality for clinical and non-clinical drug development and shortening the lead time to market
Scrum approach for Jobnet.dk streamlines collaborative process
When Denmark’s National Labour Market Authority (NLMA) needed a new supplier to develop its job portal, Jobnet.dk, and take over the maintenance of the site, they looked to NNIT. But this was no ordinary project: the NLMA wanted to use Scrum, an iterative framework for project management often used in agile software development. Following a training and test-run phase with an external Scrum coach, the NLMA, NNIT and external suppliers, the project kicked off in the
summer of 2011. A new way of working for all members of the team, the Scrum framework has helped create an open and honest collaborative environment – and a fun working atmosphere.
Improving usability with an agile approach
Jobnet.dk contains all the information necessary for job seekers and employers in Denmark. It’s mandatory for unemployed individuals to register each week in order to receive financial support, and Jobnet.dk also allows users to do this online. With 600 to 700,000 unique users and 2.5 million visits a month, the portal plays a key role in the Danish job market. Administered by the NLMA, a part of the Ministry of Employment, Jobnet was launched in 2002, and is maintained and upgraded by external suppliers for two to three year periods. In 2011, NNIT won the tender to maintain and upgrade the portal for the next two years.
For this contract, the NLMA wanted to use a more flexible approach than the traditional waterfall method they’d used in the past. Bente Dalgaard, Senior Consultant at NLMA, explains, “We wanted to improve the site’s usability, and participate more in the decision making process than we had previously, which is why we wanted to use an agile approach and Scrum. NNIT understood our needs and knew what we were trying to achieve.”
To get everyone involved acquainted with the Scrum approach before the project kicked off, two external Scrum coaches
held a one-week training session for the NNIT and NLMA teams, as well as the two external suppliers.
A fresh approach to development and maintenance
Over the past nine years, Jobnet.dk has undergone numerous updates, so it contains some complicated coding. And
because users visit the portal 24/7, bug fixes and implementing new functions must be carried out while the portal is live.
Working in 14-day ‘sprints’ – the basic unit of development in Scrum – the team writes and tests the new code according to NLMA’s specs. During daily meetings, the team addresses any challenges or problems, and prioritises tasks. Despite some early teething problems and the adjustment to a new way of working, the team is now settling in to their roles and
Scrum breaks the project down into smaller parts, in which analysis, development and tests are ongoing. NNIT Application Manager Tina Su Lyn Lim explains, “It’s been a learning process for us all. For instance, the finished code is the documentation, which is a different way of working for the developers. The NLMA has workstations onsite so that they
can work directly with the developers – usually developers don’t have direct contact with the client. And if any issues
arise, we define actions to solve them, which is a great way to deal with issues before they develop into problems.”
A close client/supplier relationship in a fun environment
Three or four releases are scheduled each year, and to date there have been two releases. “Working this way has made us a better client,” says Bente. “With Scrum, we’re much closer to the development process, and we’ve seen first-hand how difficult it is to meet some of our requirements. We’re now much better at providing input and, because we share responsibility, the end users get a better product.” Tina agrees: “Working in two-week increments means that if something is not satisfactory, the issue is raised and changes are made. This makes the process very transparent for the NLMA, as they know exactly what is being delivered.” With a little over six months of the 24-month contract period behind them, the Scrum team has built up a close relationship.
For Bente, the best thing about Scrum, is “working together to make things better – we’re not adversaries. We’ve already seen an improvement in site usability, and we hope to build on this success with some major upgrades in 2012.”
Tina adds, “The project has generated a lot of interest throughout NNIT. Word has spread that it’s a good project to work on, thanks to the NLMA’s emphasis on making it fun. There’s a huge focus on the team enjoying themselves, and the NLMA is responsible for this. We’re enjoying working together. It’s a happy marriage.”
About the National Labour Market Authority
A part of the Ministry of Employment, the National Labour Market Authority helps ensure that Denmark has a flexible, dynamic and efficient labour market. The NLMA’s main goal is to increase the supply of labour by getting people into jobs
and out of unemployment.
Scandlines is in direct touch with its business
A far more detailed insight into the business combined with a completely new set of options to control and target the marketing activities. This is the result of a Business Intelligence project (BI) where the Scandlines shipping company, assisted by NNIT, implemented QlikView as a central IT tool for the monitoring and optimization of the day-to-day operations of the shipping company.
The implementation of the BI system also paves the way for a future enhancement of the efficiency within a range of Scandlines’ business areas. Scandlines is a 24/7 business operating the ferry service between Rødby (DK)-Puttgarden (D) and Gedser (DK)-Rostock (D) all day and all year round. QlikView has helped the company get a complete overview of the development of the day-to-day shipping operations as well as the catering and retail shops on board the six ferries
and in the two BorderShops ashore. Vice President at Scandlines, Mikael Kragh, explains:
”QlikView has made a great difference to us by making us able to automate our reporting process. We are in direct touch with our sales figures, both in relation to the budget and to the previous years. At the same time, we have made a large number of resources available for more customer-oriented activities. It is a real success”.
A Flood of Reports
The shipping company differs from most other businesses because the weekend is the busiest time of the week for them. Previously, the staff was working both Saturday and Sunday where they manually produced a flood of reports, for instance on the number of customers visiting the shops and the sales they were generating. This process is now
automated. QlikView is combined with the NPrint tool to ensure that the management receives a complete report every day with visualizations of data describing the progress of the shipping and retail/catering businesses.
The daily reporting means that Scandlines can be more proactive in its marketing approach:
”If we find that we have not reached our sales figures for a given period of time, the marketing department will have time to respond to this and launch a number of initiatives to attract more customers,” Mikael Kragh points out.
Seamless and Quick Integration of Applications
Scandlines has many IT applications, and QlikView is the shared reporting tool that collects and processes data from a number of these applications.
”QlikView can be integrated with our many underlying applications in a quick and seamless manner and is able to retract data from them. Today, we apply data from five-seven different applications in the BI system,” Mikael Kragh explains.
QlikView has proved its worth during the ongoing rollout of a new Point-of-Sales system (POS) where Scandlines introduces new checkout terminals on the ferries and in the two BorderShops. The rollout of the POS system is performed ferry by ferry and shop by shop.
”The project goes on for five months and the IT consultants from NNIT have a really good understanding of what we want to achieve. Even though we operate with two different checkout terminal systems at the same time, we get completely transparent reporting with QlikView. The management can view the analyses in the BI system as if the data was supplied from the same system,” Mikael Kragh points out.
A Wealth of Data Turned into Information
The BI system is used to analyze a wealth of data. This may be data on the passenger volumes, revenues, sales of chocolate, liquor or tobacco as well as the so-called basket sizes that specify the amount of money spent by the individual
customers. In this way, the analyses provide detailed insight into the development of the different business areas on a daily basis. The BI system is also used to intensify the marketing efforts, Mikael Kragh says:
”We measure the effect of our campaigns and analyze the customer behavior. In the future, we will use QlikView to target our campaigns even further,” he says and elaborates: ”Different campaigns may have different effects depending on what time of the season it is. During the peak season, when we all go on summer vacation, one campaign type is working, and in the off-season, we get affected by other campaign types as individuals. In the future, we will analyze the effect of our campaigns year-round so that the sales and marketing departments can plan the future campaigns more accurately on the basis of the results”.
Analyses in connection with Scandlines’ loyalty program “SMILE” and the optimization of the activities in relation to the loyal customers is the most recent area within which Scandlines has applied QlikView.
”We monitor the SMILE customers and their behavior compared to customers who are not part of the loyalty program. Are their basket sizes for instance bigger than the ones of the other customers? How many points have they earned and how many points do they use to pay with again? We try to influence them to come more often and buy more,” Mikael Kragh says.
Mapping of customer behavior on the Internet is another future application potential of QlikView analyses: ”But we have not come to this yet and it will not be on the drawing board anytime soon,” Mikael Kragh points out.
IT system makes immigration application processes simpler for Danish Ministry
The Danish Refugee, Immigration and Integration Affairs Ministry handles around 68,000 visa applications each year. The Ministry used a locally hosted Integration Ministry Visa Register (IVR) system to get an overview of each case and generate important immigration statistics. But the Ministry needed to integrate its work with Schengen countries and Danish embassies around the world, so it had to update the system. Due to the complexity of the visa process, the Ministry could not use a standard case handling system, so they asked NNIT to develop a solution. The resulting system provides the Ministry’s case handlers with a detailed overview of all applications in the system. It was developed in close cooperation with the case handlers who will use the system, and gives them many new functions as well as an improved electronic workflow to reduce the amount of manual tasks they have to perform.
In today’s global world, IT systems have to run across borders and countries. For the Danish Refugee, Immigration
and Integration Affairs Ministry, this meant developing a digital visa application process that worked not only in
Denmark, but also in all the 70 Danish embassies and consulates across the globe. In addition, the system had to
meet requirements placed on Denmark by the Schengen Agreement. The Schengen Agreement has abolished all border controls between twenty-five European countries. It covers an area of 4,312,099 square kilometres and allows
freedom of movement across borders for around 400 million people. But to maintain national integrity, Schengen countries use biometric data to monitor population movement and have a common database for all visas in the Schengen area. The Ministry’s old visa application system was not sophisticated enough to deal with all the external system integration required, so the Ministry asked NNIT to develop a solution.
The Ministry also wanted to reduce the amount of manual work its case handlers have to do when processing visa applications, so NNIT developed automatic functions that reduce the work load for the Ministry’s case handlers.
With so many external systems involved – in Danish embassies and other Schengen countries – NNIT realised that a standard case handling system was not feasible. So the project team suggested a .Net-based solution. The IVR-VIS system has a central server and SQL server at its heart, and uses web services to integrate with embassy and other country systems. The team set up workshops with case handlers at the Ministry to find out their specific needs. After eight workshops, NNIT was able to develop the functions required by case handlers, including a click-once smart client that allowed case handlers to quickly access their own, locally hosted office systems. “The system works very well,” says Peter
Niemann Ogstrup, a special consultant at the ministry who worked on the project. “We now have a streamlined workflow
that integrates with both our own embassies and consulates and with all other countries in the Schengen agreement.
That gives us a far better co-ordination of cases.”
The Danish Refugee, Immigration and Integration Affairs Ministry began using IVR-VIS at the start of 2008, and case
handlers immediately had access to more comprehensive case overviews, including case lists and individual case
status reports. As a real-time system, case handlers can see up-to-date status reports on each case, making case handling more accurate, and improving the quality of the statistics collected from the system. Also, with more electronic workflow functions, individual case handlers have access custom list of cases they are working on or cases from a particular country, making it easier to find their current jobs. “More than 80% of visa applications are handled by embassies and consulates outside of Denmark, but the remaining cases are passed to the integration ministry to follow up. With the new system, case handlers can take over a current workflow with the most important information already entered,” adds Peter Niemann Ogstrup.
About the Ministry
The Danish Ministry of Refugees, Immigration and Integration Affairs deals with all issues connected with refugee and
integration policy, humanitarian residence permits and residence and permit appeals in Denmark. Its work covers developing policies and guidelines, as well as handling visa applications and appeals. It handles around 68,000 cases each year.
Novo Nordisk and NNIT develop comprehensive R&D project reporting system
In pharmaceutical company Novo Nordisk, there can be as many as 50 R&D projects running at any one time– and they are all tracked by executive management. But for management to make good decisions, they need access to all the relevant project data, including information on project progress, key milestones, budgets and patient recruitment.
Every R&D project manager in Novo Nordisk prepares a monthly report, but Novo Nordisk realised that the reporting
process was extremely time-consuming. Also, different project managers used different reporting styles, so it was hard
for management to maintain a clear overview. After conducting a LEAN study, Novo Nordisk developed an alternative,
and asked NNIT to make it a reality.
The resulting system cuts the reporting process down from a couple of weeks to just a few days – and is the first comprehensive reporting system of its kind.
Novo Nordisk’s worldwide R&D organisation includes 2,900 employees – and keeping track of all the ongoing research
projects is essential. But the company found that compiling monthly reports for executive management could be timeconsuming for project managers. Henrik Troelsen, Finance Director at Novo Nordisk, explains, “We found that
on average over 15 management reports were made each month, and some of them could take up to two weeks to
complete. The reports were often ‘handed over’ to a number of people before they were completed, and some project managers felt they were constantly involved in the reporting cycle. Also, we found that project managers were using at least 10 different reporting styles, meaning data was not presented to management in a consistent way. This added to management’s work when preparing for monthly status meetings.”
So Novo Nordisk’s cLEAN® department and Project Finance department (both part of Novo Nordisk’s Strategic R&D
area) teamed up to find a solution. The resulting LEAN study came to a simple conclusion: Novo Nordisk needed one
reporting tool that automatically pulled all the relevant information for each project into a single-page report. The project
manager would then simply add comments before pressing ‘Send’. But the big question facing Novo Nordisk was:
could it be done?
“Once we’d established what we needed, we called in NNIT,” says Henrik. “They have knowledge of the different systems
we use and understand the issues facing pharmaceutical companies like us.” The resulting solution automatically pulls
the right information for each project from three different systems: Microsoft Projects for basic project data and milestones; SAP for financial information; and IMPACT for patient recruitment information if the project is in the clinical trial phase. It then presents this information for the project manager in a one-page Excel spreadsheet.
“All the project manager has to do is write the executive summary, add comments on key project milestones and write explanations if the project costs deviate from budget,” Henrik explains. “For example, if a milestone may not be met, they add an explanation. All the information is then sent to the executive management team in a report generated from Excel.” For the development team, the biggest challenge was understanding Novo Nordisk’s complex work processes. “Our reporting system actually has four different levels and can be quite compli-cated,” says Henrik. “But NNIT was excellent: they worked closely with our team and with end users to understand our requirements – and the entire thing was driven by our internal project manager who kept everything moving forward.”
As part of the change management process, the NNIT team helped Novo Nordisk develop training materials for
users, and they created a user-support system including a Q&A site on the intranet and a Helpdesk.
For project managers, the new reporting system is proving a success. “We did a user satisfaction survey not long after
launch and it scored four out of five – pretty good for an IT system,” says Henrik. “It’s cut the amount of time
project managers spend on reports from weeks down to days – and its given them more time to dedicate to their projects.” And some of the additional features are proving popular. For example, because the system is global, project managers can complete a report from anywhere in the world. There is also a simple traffic-light system enabling project managers to flag their project if it needs particular attention from the executive management team.
So has the system helped executive management? “The reports they receive are now much simpler to read,” Henrik
says. “This saves them time when preparing for monthly status meetings. It may be too early to say if it’s improved their
decision-making capabilities, but it has certainly made sure that they have all the information they need.”
ABOUT NOVO NORDISK
Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. It is a world leader in diabetes care, and also works in areas such as haemostasis management and growth hormone therapy.
Complete data management system in dual languages up and running in just 6 weeks
Contract Research Organisations (CROs) need highly efficient data capture and clinical data management systems to ensure their clients have access to high quality data whenever they need it. That’s why leading Chinese CRO Rundo turned to NNIT when looking for a new system that could handle both Chinese and English language data, and paper and
After careful analysis of Rundo’s needs, NNIT proposed a tailored solution consisting of Oracle Clinical (OC), Remote Data
Capture (RDC) and Trial Management System (TMS). The system was installed and validated in just six weeks to ensure
it met Rundo’s specific requirements for efficiency and CDISC standard compliance. After comprehensive training by
NNIT, Rundo staff are now using the system to manage and produce data with a guaranteed error rate of less than
As a leading contract research organisation, Rundo has conducted clinical studies in more than 250 clinical research centres across China and Japan. The company offers its clients the full range of clinical research services through phases 1 to 4, including strategy consultation, regulation and registration, clinical trial management, data management, biometrics, medical writing and market research. Rundo was looking for a complete data management system that was fully validated and easy to use by its 14 monitoring teams across China and Japan.
In order to meet Rundo’s extremely high standards of data management and remote data capture, the entire system had to comply with the CDISC standard and accommodate Rundo’s strict standard operating procedures (SOPs) – including double data entry. To support Rundo’s business model, the system also had to be able to handle input and output in both Chinese and English, and be fully integrated into Rundo’s current IT system so that staff had fast and simple access to information when they need it. In addition, the solution had to be able to handle both paper and electronic data capture (EDC) because many clinical trials in China still use paper.
“Although EDC has apparent advantage, in China, there is a reality that in many clinical researches, data is still recorded by paper. Therefore we need a solution catering for China’s clinical research.” – Hua Yu, Medical Affair Director of Rundo.
NNIT began by mapping Rundo’s drug development process on an as-is basis, and conducted interviews with the major
stakeholders at Rundo in order to identify operational and strategic needs. The NNIT and Rundo project team then analysed the market offerings to ascertain the best system for Rundo’s data management requirements.
Taking into account Rundo’s current IT systems – as well as the company’s future requirements – the project team settled
on an OC/RDC/TMS package. However, it was clear that the system still had to be tailored to suit Rundo’s specific equirements and SOPs.
Once the system had been installed and validated, NNIT worked with Rundo to ensure the system met the company’s
specific requirements. NNIT created a Chinese RDC interface and helped load the required dictionaries into TMS to
ensure dual-language efficiency. Also, to ensure compliance with the CDISC standard, NNIT helped Rundo build
General Language and Instrument Behaviour (GLIB) items, which can be used in all clinical trials to significantly save time and improve overall efficiency. NNIT also drafted a Disaster Recovery Plan to ensure all data can be recovered if
a disaster occurs – and tested the plan with Rundo’s IT department. As no system is complete without skilled users, NNIT provided a three-week training course for all end users using a virtual clinical study as a training arena.
“The training for Rundo is tailor-made which is designed after several communication meetings with customer.”- Lu Lu,
Life Science Consultancy Manager at NNIT. NNIT supplied all aspects of the training, from training slides and user guides to final tests and certificates. In addition, NNIT worked with Rundo staff to design five CRFs and over 100 finished Edit-checks. “NNIT’s training is professional, efficient and pragmatic.” – Terry Sun, Data Management & Bio-statistic Director of Rundo.
Rundo’s new data capture and clinical data management system is now used by staff across China and Japan to input,
organise and retrieve essential data from clinical trials. The company’s SOPs have been fully integrated into the system’s
workflow, and the data generated has a guaranteed error rate of less than 0.03 percent.
One of the most important improvements for Rundo since implementing the new system is the ability to handle two languages as well as paper and electronic data within the same system. This enables Rundo’s clients to select the language and method of data capture needed to match the trial’s requirements. And, whatever the language or data capture method, clients know that Rundo’s processes comply with the stringent CDISC standard.
As well as delivering the system and training, NNIT is supplying Rundo with one-year of continuous technical support,
as well as conducting periodical health checks for the server and database to ensure the infrastructure continues to
meet the requirements of Rundo’s business. “Comparing with before, we have achieved a big improvement on data
management by building up a clean, pragmatic and easy-to-handle data management system.” – Hua Yu, Medical
Affair Director of Rundo.
Rundo International Pharmaceutical Research & Development Co., Ltd. is the first CRO to be formed by two CROs from
China and Japan. It provides complete CRO services, from strategy consultation and clinical trial management to data management and market research. Headquartered in Shanghai, the company has offices in Beijing, Tokyo and Osaka, as well as monitoring teams in 14 cities in China and Japan. Rundo has conducted studies in 30 different cities and nearly 250 clinical research centres.
Pharma-ready version of Quality Center brings Lundbeck’s IT systems online fast
Operating in the strictly regulated pharmaceutical industry can be tough – and all work has to meet regulations, not only research, development and production, but also IT systems. For a number of years, Lundbeck had wanted to use a test management system from Hewlett Packard called Quality Center to speed up its IT system testing processes. But the system had to be validated to ensure it meets regulatory requirements – and this was prohibitively expensive. Until, that is, NNIT offered a version of Quality Center that was prepared for pharmaceutical validation.
Lundbeck is now using Quality Center to test a range of IT systems from vendors, such as SAP and EMC. It’s made documentation to regulatory authorities considerably easier, improved testing quality, and significantly reduced the
time it takes Lundbeck to bring a new IT system online.
A research-based pharmaceutical company with around 5,500 employees across the globe, Lundbeck relies on IT systems
to keep its operations running smoothly. This means that every new IT system and upgrade has to be thoroughly checked
and tested before it’s rolled out. In addition, Lundbeck has to document to medical authorities that its IT systems
– especially those directly connected to drug development and production – meet regulatory guidelines.
Lundbeck was completing this testing and documenting process manually – and the results were stored in massive ring
binders, stuffed with printed screenshots, Word documents and hand-written notes. According to Mikael May Yde, Head of IT Compliance in Corporate IT at Lundbeck, the entire process was proving extremely time-consuming. “We were running a lot of IT projects, including an SAP implementation, and we were spending a lot of hours on testing. We printed out Word files, and filled in the results in pencil. It worked and we got approval from authorities – but it wasn’t very efficient.”
Lundbeck wanted to implement Quality Center, a test lifecycle management system from Hewlett Packard. But the
system was not set up for pharmaceutical companies, and validating it to meet regulatory approval would be expensive.
The solution came when NNIT offered a version of Quality Center that was prepared for pharmaceutical validation,
which would make the validation process much easier, and cheaper, for Lundbeck.
The system supplied by NNIT included an Electronic Signature add-on that was essential for meeting FDA requirements
as laid out in 21 CFR Part 11. In essence, the Digital Signature allows people to approve and ‘sign’ documents, like signing
their name at the bottom of a piece of paper, so authorities can see that the tests have been carried out.
Now, NNIT also operates and maintains Quality Center for Lundbeck. “Essentially, we run first and second line support,”
explains Hans-Henrik Jensen, Sr. Application Manager at NNIT. “If there’s a problem, it comes to us and we solve it.
If we can’t solve it for some reason, we escalate it up to Hewlett Packard. The idea is that Lundbeck has as little to do
with running the system as possible.” NNIT also handles setting up new users using a flexible licensing system.
Lundbeck has a total of 25 concurrent licenses. The licenses are unnamed, so anyone in Lundbeck can use the system,
and 25 people can be logged into Quality Center at any one time. In all, around 400 Lundbeck employees are trained in using Quality Center, and if Lundbeck has a large project running, NNIT simply supplies more licenses for a limited period.
Has the system improved Lundbeck’s IT testing processes? “When you develop or implement a new IT system, you want
it to get up and running quickly so you can reap the benefits as soon as possible,” says Mikael. “Quality Center has
certainly helped make projects run faster. We haven’t run a full business case, so I don’t have the figures, but I guess it
has reduced testing time by anything from 30 to 50 percent. There would certainly be a lot of unhappy people if we went back to the old system.” The cut in testing time is due to a number of factors. Lundbeck no longer uses printed paper, pencil notations or ring binders in its IT testing process. Instead, Quality Center manages the process. The information can be accessed by another user in real-time, even if that user is on the other side of the world. And because Quality Center acts as a library of tests, Lundbeck can re-use old tests when re-testing systems, and can adapt existing tests when working on similar systems – vastly improving efficiency. But perhaps more importantly for Mikael, Quality Center has helped improve test quality. “It gives us a complete overview of what tests we’ve run – and when we run a test, we get a status report. And the defect tracking function helps us find and eliminate bugs and errors. All-in-all, we have more control of the testing process, which means we always know where we are. It’s also made documentation to authorities much simpler and faster. In the old days, we had to find the ring binder and pull out the right piece of paper. Now we can get the right documentation with one click.”
Lundbeck is a research-based company dedicated to finding new drugs for the treatment of CNS disorders, including
depression, schizophrenia, Alzheimer’s disease, Parkinson’s disease and insomnia. The company’s goal is to improve
the quality of life for people with a psychiatric or neurological disorder. Based in Denmark, Lundbeck employs around 5,500 people worldwide.
Apply for a Job at JYSK via the Mobile Solution
Simple, quick, and direct. These were the requirements for the IT solution to support the recruitment of staff members at JYSK stores in 17 countries. The result was a mobile solution that is connected directly to the group’s SAP system.
JYSK has made use of modern means to attract the right employees for its stores. In all probability, it is the first large company to develop a simple mobile recruitment solution.
“Our key requirement was that it should be as easy and quick as possible for the candidates to apply for a job at JYSK. If you have seen one of our job postings, you will already be able to send us an application from the bus,” SAP HR Solution Architect with JYSK, Mathias Iversen, explains.
Even though JYSK has no problem retaining its staff, the company needs new employees for its many stores on a continual basis. In the past, JYSK lost qualified candidates because the applicants gave up in the process. The user
interface for the application procedure was too lengthy and difficult.
“We missed out on many good candidates. It simply makes good business sense to meet the candidates on their own turf,” Mathias Iversen says. He adds: “Our target group is the young generation, which is born mobile. Therefore, it has to be easy to visit our website from the mobile. And if you notice a job, it has to be easy to send an application. Furthermore, it is also easy to share the job postings on social media, so we are able to reach many people,” Mathias Iversen says.
He calls the model ’mobile first’ – and then the other platforms will follow. The aim is a quick and efficient process – for the applicants as well as the store managers, who need to hire new staff members for their stores.
Emotional Solution with a Short Lifespan
When JYSK decided to develop a mobile recruitment solution, it set up three rules: First of all, it had to appeal directly to the target group. In other words, it should be more emotional than rational.
“We wanted to distance ourselves from the complex application, where you had to click through several pages. We wanted an application that is easy and quick to complete. You should be able to apply in one single move – it should be a onepager,” Mathias Iversen explains.
The second rule requires the application to be intuitive and direct.
“A goldfish can focus its attention for nine seconds. A mobile user typically focuses on the same spot for eight seconds. This is the challenge we are facing,” Mathias Iversen says.
The third rule is a bit more surprising: The solution should be on a ’use and throw away’ basis.
“We expect to review it all over again in just two years. We believe that the development progresses at a speed that makes it necessary for us to redesign the solution in the near future. There is no such thing as a solution to meet future requirements; that was quite clear from the beginning,” Mathias Iversen says.
Separation of the User Interfaceand Business Logic
The user interface for recruitment is developed in HTML5 and runs directly in the mobile browser – or on a PC if this is required. This means that the user interface is compatible with all modern mobile phones and PCs and automatically scales to different screen sizes and operating modes – a so-called responsive design. At the same time, the solution is embedded in the existing JYSK website, which gives the impression of a more integrated and holistic solution than before.
For this solution, NNIT developed a so-called OData layer that translates the user interface with the underlying logic to the underlying JYSK HR system that is based on SAP software. This architecture is prepared for future changes.
“We can easily change the color and size of the boxes in the user interface, just as we are able to change the structure in the application procedure – and still use the same logic in SAP to process the applications and select the right employees,”
Mathias Iversen explains.
With this architecture, JYSK has obtained a solution that makes it possible to reconsider and redesign the user interface, whereas the underlying SAP solution is stable, tested, and reliable.
Find Available Local Jobs with Google Maps
Initially, the new solution has been introduced in 17 countries in Scandinavia as well as Central, Eastern, and Southern Europe – in all the individual local languages. In Central, Eastern, and Southern Europe, there are typically many applicants for each job – sometimes more than a thousand people. This requires a lot from an automatic firsthand selection and prioritization of the applications so that the store managers can concentrate on the most relevant applications. This process is handled by the logic in SAP. In Scandinavia, there are fewer applicants. Here, the challenge is to attract qualified local candidates.
“We have a visualization feature in Google Maps where you can check the map to see if there is a job vacancy in your local area. I am very pleased with this feature because it is helping potential candidates to get on the right track,” Mathias Iversen says.
NNIT Delivers a Transferable Solution
JYSK put the new recruitment system up for tender last spring and already by the end of the summer vacation period, the solution was in place.
“We talked to different suppliers and we were all very impressed by NNIT’s professionalism – and its
proposed solution. These are very sharp people, who have been able to handle the task very quickly,” Mathias Iversen says – he has assumed the responsibility for the solution after the delivery. He explains: “At JYSK, we have a policy requiring all IT content to be translated into the local languages. It is, therefore, important that we are able to manage
the solution ourselves – and change it, for instance, when we translate into different languages”.
All things considered, SAP HR Solution Architect with JYSK, Mathias Iversen, is very satisfied:
“JYSK has obtained a reliable solution that can be renewed and developed further without changing the underlying business logic. This setup ensures that JYSK will be able to attract the most qualified employees and that is one of the basic preconditions of the continued success of JYSK.”
The game provider Danske Spil protects personal data according to the EU General Data Protection Regulation
The customers must have confidence in the data security that is in place; it is crucial for Danske Spil’s business. Therefore, the game provider is preparing itself for the implementation of the GDPR in order for its customers to trust that their sensitive personal data are protected.
Danske Spil handles huge amounts of personal data, so it is crucial for the game provider that the customers’ data are safe. In addition to the sensitive personal data of their employees, Danske Spil possesses, among other information, the civil registration numbers of online customers, credit card information, and statistics of the customers’ individual game consumption – including sports games like the Oddset and a wide range of online casino and poker games.
That is why Danske Spil has given priority to fulfilling the EU requirements since the GDPR was announced.
”We have always taken data protection very seriously. We handle customer data that are
of a very sensitive nature, so ensuring our costumers’ confidence in us is crucial. This confidence must be maintained as it does indeed form the basis of our business. Confidence cannot be compared, and lost confidence is difficult to reestablish,” says Phillip Badstue, Head of Data Security at Danske Spil.
Mapping of all the data flows
As a first step toward meeting the EU GDPR, Danske Spil has cooperated with NNIT with
a view to mapping the data flow of the organization. During this process, a wide range of key employees working with critical data have been interviewed in order to reveal all of the touch points with personal data.
”We have mapped every touch point across the organization. As the GDPR has a huge impact on our business routines and future projects, we have given priority to having our own employees participate in the process. By actively cooperating with NNIT and not just outsourcing the process, we ensure that, afterwards, we will be able to continue the requirement-related work on our own,” says Phillip Badstue and he continues:
”The mapping has enabled us to identify the areas that are to be focused on. Now, we know the life cycle of all of the personal data from their first appearance with us, and we know how they move, both internally as well as externally. All of the data are now searchable
at the flow level and data type level, which enables the launch of targeted measures that improve safety even further”.
Personal data security should be incorporated in the entire business
Danske Spil’s high ambitions will impact the game provider’s future projects and the organization’s numerous suppliers, including technical providers of online games and services beyond the core business.
To combat compulsive gambling, Danske Spil has recently started cooperating with psychologists in order to develop an algorithm that detects the beginning of gambling addiction in customers. If, based on a customer’s gambling pattern, gambling addiction is suspected, the system will issue a notification and Danske Spil will contact the customer concerned by making a ’care call’.
After the data flow mapping, Danske Spil has chosen to encrypt data concerning customers with a gambling disorder in order to ensure the best possible protection of their privacy.
”The GDPR has a significant impact on our business and involves an obligation for us to rethink several of our projects. We have clearly defined requirements to our suppliers in order to ensure the protection of our customers’ data, no matter where they are processed.
We must be able to guarantee data safety and confidentiality for our customers, but as the game sector and technologies develop continuously, this effort will never be achieved once and for all,” says Phillip Badstue.
Implementation of SAP Information Lifecycle Management for GDPR
From a legal perspective, it is crucial that unnecessary data is deleted – and from a business perspective, it is crucial that they are deleted in the correct order. Based on process and data analysis, NNIT is helping a company to set up a rule-based deletion process in a comprehensive and complex SAP solution. The project is agile, and it is giving fast results.
NNIT is helping a major Danish company to implement an SAP Information Lifecycle Management (SAP ILM) solution that trawls through the company's SAP system and uses rule-based deletion to delete all the non-consented and non-permissible data in the system. The stricter GDPR legislation as of May 25, 2018 means that the company, as with all other companies in the EU, must be able to demonstrate that it manages personally identifiable information in a responsible manner.
Automated and rule-based
The fact that SAP ILM is rule-based means that it is possible to analyze the data set based on its own defined regulations, for example the Accounting Act. It can then automatically delete data that is no longer authorized according to the selected rules.
–SAP ILM also allows us to incorporate a blocking solution that differentiates between who is allowed access to which data and when. It continuously blocks access to data, so only the relevant employees have access at any given time, explains Rasmus Jakobsen, Manager of Enterprise Information Management, SAP Solutions at NNIT.
Cost-effective deletion routines
However, the ILM solution does not stand alone. This specific SAP system has been around for 20 years, and older SAP solutions often contain features that are no longer in use, but which still contain personal data. Here it does not make sense to set up rules in SAP ILM and run them once, as it will typically be necessary to delete entire tables or functions. Instead, NNIT has helped the company implement a series of deletion routines that result in a deletion report, which can be reviewed and approved by a decision maker.
– Of course, it is crucial that data is deleted in the correct order so that it does not destroy essential information or functionality elsewhere in the system, emphasizes Rasmus Jakobsen.
High data and system complexity
The company holds massive amounts of personally identifiable data including health, assets, insurance, identification numbers, and employee contracts. This data must now be cleaned up so that the company complies with GDPR. However, mapping and deleting such amounts of data is no easy task.
– There is no doubt that the level of data complexity here is very high. In this company, employees are not just employees, but also customers. There is a great deal of interlinked data; some of which is relevant to some parts of the customer relationship, but not to others. At the same time, the 20-year-old SAP solution has been continuously upgraded and changed, and in many places there are old functions no longer in use that contain data, explains Rasmus Jakobsen.
Agile data cleaning in three waves
As the GDPR deadline approaches, NNIT and the client organization have chosen to complete the project in three waves. By May 25, 2018, the first wave will be over, and the first major clean-up will be completed.
After that, NNIT will initiate an ongoing, rule-based data cleaning process.
– The entire project has been developed using the Scaled Agile Framework® (SAFe), similar to SCRUM. This means that the project does not define in advance exactly what to delete and when. Instead, we aim for continuous learning. In a comprehensive compliance project like this, it is only natural that we will learn from good routines, as well as face changes in scope. The project, of course, must be able to take this into account, explains Rasmus Jakobsen.
The choice of NNIT was largely due to its agile project management, the three waves, and a high level of confidence in NNIT’s ability to deliver within scope and on time.
Are your system solutions GDPR-ready?
The vast majority of organizations are well into the process of conducting data analysis with the regulatory framework of GDPR in mind. But does your organization also have a good system solution ready and waiting? Contact Rasmus Jakobsen, Manager of SAP Enterprise Information Management at NNIT, to learn more about how to implement good deletion routines in an agile project.
Rasmus Jakobsen, Manager of SAP Enterprise Information Management at NNIT, email@example.com or +45 3077 8563
Real-time data access boosts decision-making at retail client
In an agile process that allows for continuous integration and delivery, NNIT has developed an Azure-hosted data platform solution, which utilizes the client's on premise data. The objective is to supply pharmacy employees with near real-time sales data and a variety of key metrics to support decision-making.
By implementing a new solution hosted in the Microsoft Azure Cloud – but utilizing on premise data – a Danish pharmacy has dramatically reduced load time on an advanced analytics platform, which provides fast access to consistent sales data.
The pharmacy was looking to create a solution that allows for fast access to data in order to actively include the data as a foundation for decision-making. The new solution provides near real-time sales data all while increasing the number of key metrics available to the employees and other stakeholders.
An agile process quickly deploys new versions
NNIT was responsible for delivering a sales reporting application to support the client organization's digitization strategy.
The complete setup embraces an agile process with elements from SAFe and SCRUM as well as continuous integration and delivery – thus making sure new versions are quickly deployed through the relevant environments when thoroughly tested.
Scalable and flexible
The application leverages the newest technologies such as Microsoft Power BI and .NET Core as the main building blocks and is hosted in the Microsoft Azure Cloud.
Multiple relevant Azure PaaS components have been utilized to make the solution as flexible and module-based as possible. The technology stack was chosen to fit the client's exact needs, and should they change in the future, the solution can easily be scaled, or additional features added.
Ensuring user-friendliness through education
Before launching, the project's pilot phase tested the solution for several months to identify and counter any weakness. Today, the solution serves thousands of users across Denmark.
To ensure that the users understand how to employ the new solution and all the application, NNIT and the client collaborated to develop comprehensive learning material and conduct meetings that address any concerns or questions regarding the solution.
Do you want to know more about data access in Azure-hosted solutions?
Real-time data access is often the be-all and end-all of decision-making in innovative projects. Digital solutions hosted in the cloud can utilize and correlate both off- and on-premise data and create unique and valuable knowledge.
Book a meeting with NNIT's cloud specialist Massimo Giulio Caterino firstname.lastname@example.org to find out how you can implement cloud-based, scalable solutions.
New project with Arla Foods is a big success
Since 2013, NNIT has been an important IT partner for Arla Foods. Half a year ago the two parties decided to start a major ITSM Change integration project to take yet another step on the road towards digital transformation.
The challenge facing Arla concerned changes to Arlas Foods’ IT systems. Such changes had to be made manually. The Change process is a major and data-heavy undertaking, and because all changes must be fully controlled, documented, risk-evaluated and quality-assured, it has also been a time-consuming process.
With this in mind, NNIT designed an automation engine to digitize this process. Now, data can be exchanged quickly, safely, and efficiently; making the whole process far more agile.
Claus Koch Pedersen, senior IT manager at Arla Foods, explains:
Automation minimizes errors
Anders Bigum, NNIT's delivery director, was more than happy to be involved delivering this kind of improvement to Arla. We have tied the systems together, which is a very big step on a digital journey. The way system changes are managed has been completely transformed, and now hundreds of changes can be made at the same time.
Previously, NNIT and Arla Foods used two different systems without automated interface to manage changes. The process was time-consuming and associated with the risk of manual errors.
We are constantly working to improve, streamline and remove unnecessary manual labor, where it makes sense to do so. These processes were especially well-suited to our agenda of automating these processes together with NNIT, says Claus Koch Pedersen from Arla Foods.
There are many benefits to automation - especially in making workflows more efficient, explains Anders Bigum from NNIT:
Automation provides Arla with a faster, smarter and more stable operation where time is not spent on corrective actions, reworks and so on.
First movers in digital solutions
With this ITSM Change Integration, the automation engine can also be used in other areas; raising data quality on several fronts. The initial set-up phase is the most resource-consuming, but Claus Koch Pedersen expects that the new change process will provide a shorter lead time and a faster time to market, which will benefit the Arla business. With less manual work and therefore smaller risk of manual errors, we will experience a faster time to market which is essential for Arla due to our Digital Transformation. The project is the first step on the journey and will certainly serve as a catalyst in other areas, says Claus Koch Pedersen.
It has been a collaboration that has benefited both Arla Foods and NNIT. Anders Bigum is extremely satisfied and sees great value in the fact that Arla Foods dares to be a frontrunner in digital transformation.
At NNIT, we find it exciting when customers are eager to try new things out and be first movers - it’s certainly a worthwhile investment. We have learned a great deal from the project, so now we need to take our experience to other customers, he says.Claus Koch Pedersen explains that he is also extremely pleased with the collaboration and sees it as a win-win project: NNIT has taken the project seriously and managed it safely from start to finish. Our people have been fully committed and the work has run smoothly. Arla Foods wants to take bold decisions and is therefore not afraid to take the first step, take a chance and develop a set up that can benefit other companies, says Claus Koch Pedersen.
Global And Local IFRS 16 compliance in SAP ERP Core
NNIT helped a life sciences client achieve full compliance with the new International Financial Reporting Standards (IFRS 16). The project was completed well ahead of the regulatory deadline and included both an integrated addition of the client’s SAP solution, training and consulting on new business procedures.
The implementation of the International Financial Reporting Standards 16, (IFRS 16 Leasing) pose both an organizational and technical challenge for many other organizations. The new standards mean that companies must change the way they handled the reporting of numerous leased assets, from buildings and cars to lab equipment, in their accounting standards.
For one of NNIT's life sciences clients, it meant that changes would have to be made to the client's existing SAP solution, and internal accounting procedures would have to be modified, on a Group level as well as on a local level. Reaching the January 1st, 2019 deadline without being fully compliant with the new regulation was not an option.
Short lines of communication
After deciding to enhance their SAP solution rather than go with custombuild software, the client chose NNIT as their implementation partner. This was based on NNIT's extensive SAP experience, the project proposed use of standard SAP functionality and the proposed project model, which used elements from agile project management to ensure close cooperation between the different stakeholders.
– Our project model established developments in Sprints and very short lines of communication between the business owners in the client's corporate finance department, their IT staff and their Finance Center of Excellence. This gave a close teamwork, both on a corporate level and with the system users, which was very effective, says Hans Mathiesen NNIT's project manager on the project.
Getting the foundation in place
To accurately scope the project, NNIT worked closely with the client's IFRS experts from corporate accounting. The changes had a big impact on the reporting and required data collection from all their corporate entities. NNIT helped develop templates to structure the data collection from hundreds of different sources, ensuring that all relevant data was collected in the right format and following a correct process, and updated correctly for the maintenance of the leasing contracts.
A fully integrated solution
Once the process for data collection was clearly defined, the project team identified three different types of leasing contracts that needed to be handled in SAP in their own way:
One for buildings
One for vehicles
One for miscellaneous equipment.
NNIT configured SAP Real Estate and Contract Management system (SAP RE-FX) as a fully integrated solution capable of handling all the contract types, which was then verified by the client's IFRS experts.
– We were able to accomplish our goals using standard SAP elements, with no need for custom developments or integrations. Once the leasing contracts are uploaded, the interest element, the right of use assets are automatically created and capitalized along the corresponding liability. Furthermore, reports such as liability grading and reclassification are delivered as a standard. This requires new accounting processes, but many of them can be automated. From a software perspective, it's a relatively simple task, but it is time consuming for the system and process owners to create and anchor the new way of handling an organization's lease portfolio, says Hans Mathiesen.
Change of scope
In order to ensure that all users were familiar with the correct procedures for using the new system, NNIT carried out extensive training of the client's global finance organization. The process for data input was finalized during the project and in this connection, NNIT's agile project model was put to the test when it became clear that a change of scope was needed.
The issue was that while IFRS 16 is an international standard, individual countries have different variants of adaptation, depending on their local financial and tax laws. This means that the local and regional finance staff's reporting obligations for leasing data would vary from country to country.
– At first, we were looking for an IFRS 16 solution on a group level, but we realized that we would also need to take local variance in legislation into consideration. To avoid putting the burden on local finance, the client decided to centralize, so all data input is handled by their Global Finance Service Center of Excellence. Using this model also means lower license cost, says Hans Mathiesen.
Completed on schedule
Despite the need for scope adjustment and changes in procedures, the project was completed in just eight months, and the client reached full compliance well ahead of the regulatory deadline.
Does your organization need help with SAP?
Book a meeting with Hans Mathiesen at email@example.com