Project Partner
Lundbeck is a global pharmaceutical company highly committed to improving the quality of life of people living with 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 disease areas such as depression, schizophrenia, Parkinson’s disease and Alzheimer’s disease.
Project
As a large R&D organization with clinical sites around the world, Lundbeck needed a cold chain monitoring solution that streamlined end to end processes communicating temperature data that would ensure successful clinical trial progression and cost-effectiveness. In addition, it was their priority to meet new GDP requirements to demonstrate control during transport by collecting data and having an auditable database.
Previous data loggers were often returned from sites to the Lundbeck QA team for evaluation. This caused a lot of unnecessary time for receiving sites as well as QA to evaluate excursion data after they were sent back. This lengthy process delayed decisions on-site that potentially could have delayed a clinical trial. The previous data loggers created different report formats in different systems, depending on what data logger the supply chain partner was using, preventing common processes and comparison of historical data.
Lundbeck was looking for a new solution with these requirements:
- Easy for receiving sites to read alarm/no alarm
- Multi-level alarm feature to make use of available stability data
- Simple process to get data from receiving site to QA
- No need to physically send back data loggers to origin
- Central, traceable database and archive accessible from any location
- No software needed nor individual log-ins for each site, rather central QA controlling the database
Find out how ELPRO provided Lundbeck with a cold chain monitoring solution that streamlined end to end processes ensuring successful clinical trial progression and cost-effectiveness.