Ensuring Biometrics Excellence in Clinical Data analysis

When it comes to managing biometrics for clinical data, it is common for pharmaceutical or biotech companies to partner with a Contract Research Organization (CRO) to deliver SDTMs, ADaMs, and TLFs for clinical studies. Often, programmers or biostatisticians from the pharmaceutical company will rely on these deliverables to create integrated submissions for regulatory agencies. However, one major challenge in this setup is that data or reporting issues are sometimes discovered late in the development cycle, which can cause significant delays.

While companies delegate responsibilities to CROs, the sponsor ultimately remains accountable for the final results. This makes regular reviews of data quality and adherence to standards crucial. Keeping well-documented communication between the sponsor and CRO ensures that the biometrics work is accurate and efficient, maintaining the integrity of the study. In its 2013 guidance on risk-based monitoring, the FDA emphasized that even when sponsors delegate monitoring responsibilities to a CRO, they must still oversee the CRO's work. This includes reviewing monitoring reports, assessing performance and quality metrics, and ensuring clear communication between both parties on the progress of the work.At OCS Life Sciences, we understand the importance of effective CRO oversight and are committed to ensuring your studies meet the highest standards of compliance and biometrics quality. We offer a range of services to support your CRO oversight for biometrics, including: