Every year Veeva’s Paperless TMF (trial master file) Survey provides insights into the state of electronic TMF (eTMF) adoption in clinical trials. This year marks the third year for the survey, which explores the life science industry’s progress in streamlining clinical trials and efforts to unify clinical operations.
Clinical Operations (ClinOps) leaders increasingly outsource critical components of their trials. By one estimate, 75% of pharmaceutical and biotechnology companies are now outsourcing data management and over 70% are outsourcing site operations. As a consequence of the growth of this practice, effective collaboration between Sponsors and their CROs has never been more critical for achieving clinical trial milestones on-time and within budget.
Innovation is shaking up the world of clinical trials. Advancements in technology are rapidly changing the landscape of data collection and analysis, while patients and patient advocacy groups do their best to get their voices heard in the process of planning and executing trials. But while we often hear references to disruptions in clinical trials, it can often be difficult to identify exactly what is disrupting the process.
Having grown to a premier research organization with 400 clinical trials to its credit, HCRI’s clinical trial management needs had surpassed the conventional processes it had been using to manage and monitor information and documents related to its clinical studies.