Clinical Monitoring

ResearchPoint conducts all clinical monitoring in accordance to ICH and GCP guidelines. We prefer to dedicate CRAs to a project, allowing each CRA to focus on the needs of your project, and to truly know your study. Using this approach, the CRA becomes a true partner, representing each sponsor in a highly integrated and professional manner.

To ensure maximum performance on each clinical trial, ResearchPoint’s CRAs are afforded three types of training:

• Indication-specific training, including current treatments and standards of care
• Protocol training, including study goals and objectives, investigational product and mechanism of action, and schedule of events and timelines
• Study process training  including, appropriate/proper identification of site issues (violations, compliance, etc.), analysis of causes of each issue, development (in conjunction with site and PI) of a corrective action plan, and effective documentation

ResearchPoint’s business model is unique in that, for larger studies, our study team includes a Clinical Manager to provide oversight of monitoring functions.

• Clinical Managers are experienced in both monitoring and project management. This experience provides the ideal background to ensure consistent monitoring across all CRAs.
• Hands-on support allows the monitoring team to quickly resolve some of the most common study issues, from slow enrollment to excessive queries.

ResearchPoint tailors our monitoring approach to the needs of individual sponsors and studies. We are flexible and can provide a fewer number of CRAs for a dedicated team, or we can provide a larger number of geographically dispersed CRAs to provide a more regional approach.

 

With an average of 10+ years of experience, a dedicated Clinical Manager, and over 75% CCRA accredited monitors,
We only have an A-team.