Right-sizing a Clinical Compliance Program

Right-sizing a clinical compliance program in a small pharmaceutical company requires careful consideration and strategic planning. While the specific details will depend on the size and nature of your organization, there are some general steps to help you right-size your clinical compliance program.

Start with the basics by familiarizing yourself with the applicable regulations and guidelines that govern early phase clinical trials and research in your region or country. It’s important that you have a comprehensive understanding of the compliance obligations specific to your organization.

The next step is to assess your organizational needs. Questions to ask may include: what is the type and scope of clinical trials you conduct? Healthy volunteer studies may need far less complexity of oversight than personalized cancer trials. Identify the critical areas that require compliance oversight to ensure patient safety and data integrity. How many employees are involved? What types of outsourcing do you do and who within your organization is overseeing the outsourcing? Who holds your TMF and how often do you check for completeness? The recently released ICH E6 (R3) lays out in Section 3.9 the expectations for Sponsor Oversight, covering everything from trial design and conduct to organization and oversight of data monitoring committees and similar.

Establish a quality assurance and compliance group, even a small one to start. In a small pharma company, this QA/C might consist of a compliance officer or manager who has a solid understanding of clinical trial regulations and can provide guidance and support to other staff members involved in clinical research. As part of your oversight, provide regular training and education to employees involved in clinical research, including investigators, study coordinators, and data managers and make sure you track the training for future inspection readiness activities. Training should cover good clinical practice (GCP), the company’s internal policies and procedures, and safety reporting. This sets the tone for a culture of compliance within your organization.

In a small company, you may need to use external experts for monitoring and auditing processes. Even if you’re outsourcing most of your activities, the sponsor retains oversight responsibilities and is answerable to the regulatory authorities. Ensure you have a good oversight model for all your vendors -whether it’s a CRO or a PV reporting group. This will help you to identify any areas of non-compliance and take corrective actions promptly.

Once having put the basic structures in place, as your company grows and you move into later phase trials, you can scale up a well-structured compliance group. Often sponsors follow the CROs SOPs for the majority of activities, especially in early phase clinical trials. Thus, you’ll need some basic SOPs of your own in place that help you fulfill your oversight responsibilities as the sponsor, even if the CRO Is executing on your behalf.

For basics, it’s important to have a vendor oversight SOP that clearly defines how vendors were chosen and how you monitor activities being done on your behalf. Same goes for TMF oversight – the CRO may hold the study TMF but how is QC performed to ensure the TMF is current? This may need to go in a TMF Plan or it could be part of your study plan. The goal is to ensure your vendors are working to standards set out in regulatory guidance on your behalf.

If you are looking to create a right sized clinical compliance program, Just in Time GCP offers a QMS gap assessment that can serve as a great starting point for understanding your organizational current and future needs.  We have a team of experienced GCP compliance individuals that will meet with members of your team to understand your current state and then help you to build out a future state that aligns with your organizational needs.  Reach out to us at info@justintimegcp.com for more information.  Let us take the stress out of GCP compliance.


Europe.eu ICH E6 (R3) Guideline on GCP


By Barbara Clough, Associate Director, Consulting at Just in Time GCP

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