01.20.23 -- Best Practices For Risk Assessment Of GCP Vendors

Requirements for risk management in clinical trials are outlined in GCP (R2) and provide you, as the sponsor, with the main steps for risk management in your studies. The implementation will vary from vendor to vendor depending on their delegated duties and functions. In addition to that, there are three other important considerations.

When you think about integrated monitoring, what does that really mean? Learn how technology and monitoring fit together intelligently to reduce your workload within clinical trials. Find out more in the third blog within this RBQM series.

Phase 2 clinical trials are like software development. How so? Ivanna Rosendal explains the connection and makes the case for using a now-ubiquitous software development workflow to improve clinical data management.

From medical monitors and biostatisticians through safety and pharmacovigilance scientists, the need for timely and informative data analysis and visualization tools to facilitate in-study safety data review and more extensive pharmacovigilance (PV) is becoming more apparent.

EDC alone cannot solve the data challenges posed by hybrid digital trials. Discover how this role can be taken on by also aggregating, cleaning, and providing user-based access to all trial data.

Trials are becoming more complex in nearly every therapeutic area. While complex trials are important to getting treatments to market faster, they are challenging to design and conduct.

Medidata Link is the only centralized technology solution that works across research sites to connect patient-level CTD and RWD.

MRN’s eVRF (e-visit report form) is an electronic form tailored to match the needs of each clinical trial and used to capture subject and clinical data during the home trial support visit.

Cognizant Shared Investigator Platform (SIP) provides a single point of access for multiple clinical trial resources across sponsors and investigation sites.