Mar 07, 2016
Princeton, NJ, January 28th 2016 – Lundbeck is a global pharmaceutical company committed to improving the quality of life of people suffering from psychiatric and neurological disorders. For this purpose, Lundbeck is engaged in the research, development, production, marketing and sale of pharmaceuticals across the world. The company’s products are targeted at diseases such as depression, schizophrenia, Alzheimer’s and Parkinson’s diseases. Lundbeck was founded in 1915.
Research and development
Lundbeck is one of Denmark’s most research-intensive enterprises and employs 1,000 highly-trained specialists in research and development units. Each year, Lundbeck reinvests around 20% of its revenue into research and development of new pharmaceuticals to improve treatment options for the millions of people around the world living with brain disease.
Lundbeck has invested in both ArisGlobal®’s Register™ (for regulatory tracking) and ARISg™ (for Pharmacovigilance and Drug safety reporting) worldwide. Both systems were implemented on the internal Lundbeck IT infrastructure and have been in place for several years. However, when considering the upgrading of these applications the following business problems were seen as a compelling reason to re-evaluate the on-premise model and investigate outsourcing:
1. Cost of maintaining a compliant system for global Pharmacovigilance and Regulatory reporting obligations with the associated maintenance and upgrade efforts required
2. Increased Drug Safety and Pharmacovigilance activities with a need for affiliates to enter cases more efficiently
3. Upgrading the Regulatory (RIMS) application to meet evolving XEVMPD requirements required compatibility with ARISg™ versions for future converging data requirements
4. Need to find a reliable and cost effective hosting partner to meet Lundbeck’s corporate strategy of moving to cloud over the next few years
5. Ensure a system that is updated to comply with current regulations at all times in an regulated environment with frequent changes
Following a rigorous evaluation process Lundbeck chose ArisGlobal® to implement the Total Safety™ suite on the LifeSphere cloud to replace the existing internal ARISg™, ESM, agSignals™ and agComposer™ system. The new Total Safety suite extends the capabilities to affiliate data entry and compliance monitoring through the addition of new modules agXchangeIRT and agXchangeOST.
Following a successful go live of the hosted Total Safety™ suite, Lundbeck then considered the upgrade of Register together with a move to on the cloud to complete a fully outsourced regulatory and safety systems strategy. ArisGlobal® were awarded this contract in September 2015 and is now responsible for providing a fully validated and compliant cloud solution for global RIMS, Drug Safety and Pharmacovigilance to Lundbeck.
“Lundbeck believes that the ArisGlobal® Total Safety™ suite on the cloud platform is the right solution, in order to minimize maintenance and upgrade costs/resources, and for us to focus on our key deliverables – our pharmaceutical products and development projects”
Jens Peter Balling, MD
VP, Pharmacovigilance & Clinical Quality Assurance
The business benefits identified by Lundbeck to move both Regulatory and Drug Safety/PV from the in house model to software as a service (SaaS) with ArisGlobal are as follows:
1. Single interface and point of management with end to end accountability to provide hardware/ software support, backup and monitoring and ensuring successful delivery of all committed SLA’s and overall quality
2. Common Governance Framework & pre-defined escalation path to administer both systems
3. Common service performance metrics managed and monitored by one single team set-up for both systems; providing consolidated dashboards and SLA reports
4. Integrated systems with dictionary and data updates between Regulatory and Safety enhancing efficiency and alignment with regulatory changes
5. Regulatory compliance maintained by providing necessary legislated updates on a common GXP validated Cloud for both business domains
6. Future-ready for new modules to be added within the pre-validated environment allowing minimum time and effort for accelerated deployment with great flexibility and scalability