A well-run trial requires that CRAs truly understand critical aspects of the protocol, investigational product, study conduct and various data points.  Given today’s environment of global and remote monitoring, it is critical the monitoring team has study specific training with emphasis on key information, which lays the foundation for site training, monitoring, and ensures study success. BIA collaborates with clients to provide the critical study specific training of CRAs prior to site initiation and key study milestones, ensuring consistency throughout the trial.

BIA has built a team of US-based CRAs, who are fully trained on the BIA way of monitoring. These high-quality monitoring services ensure that sites are well managed throughout the study, and that proper oversight is maintained.

Now more than ever, monitoring oversight is a critical component to managing a well-run trial. FDA’s guidance for a risk-based approach to monitoring requires even more oversight of Sponsor’s critical data. Sponsors need to ensure that oversight is ongoing throughout the duration of the trial and is well documented.

If you have outsourced your monitoring to a CRO, BIA can provide monitoring oversight services to ensure that every site is being managed and monitored per the protocol, monitoring plan, GCP and FDA guidelines. If you are struggling with the experience of your CRAs, turnover, quality of monitoring, site coverage and even deviations, BIA will work with you to create an oversight plan to get the trial back on track. The plan will identify the specific issues and sites at risk, using our proprietary monitoring oversight checklist.