Cerevel Therapeutics
A 'forward thinking' approach to digital archiving
You can access the full Cerevel case study here.
As a partnership between Pfizer and Bain Capital, Cerevel Therapeutics was established in 2018 with the mission to push boundaries, develop solutions, and transform lives of people living with some of the most devastating neuroscience diseases, including schizophrenia, Parkinson’s, and epilepsy.
Building on the foundation of Pfizer research, Cerevel intends to become the premier neuroscience company. Currently, they have three ongoing Phase 3 trials and an open-label extension trial for tavapadon in Parkinson’s, two ongoing Phase 2 trials and an open-label extension trial for emraclidine in schizophrenia and an ongoing Phase 2 proof-of-concept trial and an open-label extension trial for darigabat in focal epilepsy.
A large proportion of these records and data are managed through Veeva, their live electronic Trial Master File (eTMF) solution. While this system is an effective solution for the management of the live trial data, Cerevel is aware of the limitations of using this system for the archival of their records.
Access the case study here to discover how Cerevel partnered with Arkivum to ensure GDocP and regulatory compliance for long-term data integrity.
Testimonial
It was also important for Cerevel to comply with EU clinical trial regulation (i.e., EU Regulation 536/2014) around data retention, despite being located within the U.S. This relatively recent update (came in effect in January 2022) to EU regulation stipulates more stringent retention requirements and in turn, has become to be seen by many as a gold standard to adhere to.
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