Richard Young, vice president of Vault CDMS - Veeva Systems gives EPM some insight how a centralised data strategy can effectively manage clinical data.
Key highlights:
- Sponsors have conducted decentralised trials for over a decade, yet companies are challenged to access a more diverse and comprehensive data set.
- During the pandemic, some pharma companies invested considerably in decentralised trial technologies, only to find that data could not be connected or verified.
- Both unifying data management and recording the patient journey are essential for a clinical data strategy and decentralised trials.
- Instead, most organisations use manual methods to aggregate and clean each data silo individually.
- This problem originates in the earliest days of traditional electronic data capture (EDC), where data sources were fragmented and isolated as we prioritised speed of collection over analysis. New trial designs requiring faster decision making and flexible data management are transforming this approach.
- Aggregating data in a central clinical data management system (CDMS) is crucial to achieving the visibility and timeliness that contribute to more effective trials.
The COVID-19 pandemic brought the industry together in a unique way to address digital trials. It led to much innovation, adaptation, and adoption of decentralised clinical trial models allowing patients to participate without repeated site visits, whilst helping sponsors increase enrolment and prevent attrition.