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How To Fix Poor Clinical Document Compliance At Clinical Sites

Keeping sites in compliance with their required documents is an ongoing battle for every sponsor and contract research organization (CRO). Considering the volume of documentation involved in a clinical trial, it’s no wonder why sites struggle to stay on top of it, or why sponsors and CROs get frustrated when auditors issue findings against them because their sites are out of compliance.

This frustration can be lessened by:

  • Providing sites with greater visibility into their document compliance status
  • Automating notifications related to upcoming and past-due document deadlines
  • Enabling easier document reviews, approvals, and sharing back and forth

One of the most effective solutions we’ve seen for this issue is described in the blog post, How To Improve Clinical Site Compliance With Essential Documents. This approach empowers sites to manage their own document compliance status, makes it easy and convenient to do so, and reassures them that sponsors/CROs are supporting their efforts. You would be amazed how much something so simple can improve relationships with site coordinators.

To learn more about common issues with clinical sites and how to fix them, check out this guide.

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Marin Richeson

Marin joined the life sciences industry in 2001. Over the course of her tenure, she has held roles in clinical finance, IT, quality assurance, and validation. The diversity of her experience provides her with a unique perspective on the interconnectedness of this complex, multi-faceted industry. Marin Richeson is a lead business consultant in Perficient's life sciences practice.

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