Is My Study in a Healthy State?

Depending on the phase and progress of a clinical trial, timelines and scope can be constantly changing. Unfortunately, personnel may also shift throughout the length of a study, which leaves new study personnel trying to play catch-up, and fast.

What is the easiest way to track the health of a study? Are study documents inspection-ready? Do we as a sponsor/CRO have the means to do this type of tracking ourselves?

In our 37+ years in the TMF Support space, DRS has developed the TMF Oversight Report, which was specifically designed with the sponsor/CRO in mind.

The DRS Oversight Report is a compilation of GDP metrics which shows the overall quality of document submissions into the eTMF. Instead of the sponsor/CRO exporting and evaluating data themselves, DRS Clinical Document Analysts (CDAs) will review the metrics and provide a monthly, bi-monthly, or quarterly report. This will give sponsors/CROs a real-time look at the health of their ongoing study.

There are several benefits to this type of reporting:

• Quality: reviews are a continuing effort to reduce and resolve errors, duplicates, and GAPs before the end of the trial
• Presence: shows the GAPs in the study so document submitters know what still needs to be sent to the eTMF
• Time: helps button up any issues with the TMF as the study progresses instead of saving the review until the end
• Assistance: DRS has tailored the summary and data reports to best help the sponsors/CROs see a real time snapshot of the study on a scheduled basis. Basic analysis of the data is completed by DRS CDAs to help take some of the burden off of the sponsors/CROs

If this is something that resonates with you and your study, please feel free to reach out to the DRS Corporation team for assistance in keeping you inspection ready.

Website: https://www.drscorp.com

Email: [email protected]

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