Right-sizing a Clinical Compliance Program

Navigating the intricacies of clinical compliance in a small pharmaceutical or biotech company demands meticulous planning and strategic thinking. Although the particulars vary based on your organization’s size and business model, there are fundamental steps to help tailor your clinical compliance program effectively. 

Grasp the Regulatory Landscape:  

Begin by acquainting yourself with the relevant regulations and guidelines governing clinical trials in your operating region. Understanding your compliance obligations specific to your organization is paramount. Transitioning from conducting Phase 1 and 2 studies solely in the US to Phase 3 global trials necessitates aligning your compliance program with diverse global requirements. 

Assess Organizational Needs:  

Evaluate your organizational requirements. Determine which responsibilities to retain in-house and which to delegate to Contract Research Organizations (CROs). Establish clear procedures for performing investigator site monitoring or develop oversight mechanisms for outsourcing this responsibility. Pay special attention to the management of the Trial Master File (TMF), ensuring its completeness and inspection readiness.  Having a process for oversight of key study activities is critical to effective quality management.  The recently released Draft ICH GCP E6 (R3) lays out the expectations for Sponsor Oversight, covering everything from trial design and conduct to organization and oversight of data monitoring committees. 

Establish a Clinical Quality Assurance and Compliance Group 

Even in a small organization, institute a QA group comprising a compliance officer or manager well-versed in clinical trial regulations. This group provides guidance, supports staff involved in research, and oversees training initiatives. Regular training sessions covering GCP, internal policies, and safety reporting foster a culture of quality and compliance. 

Utilize External Expertise 

In smaller organizations, leveraging external experts for Quality Assurance and compliance can be beneficial. Despite outsourcing activities, sponsors maintain oversight responsibilities. Develop a robust oversight model for all vendors, facilitating the prompt identification and rectification of any non-compliance issues. 

Lay a Quality Foundation 

Establish a solid compliance framework from the outset. As your company expands and progresses to later-phase trials, scale up your compliance group accordingly. Even if relying on CRO SOPs initially, having basic standard operating procedures ensures alignment with regulatory requirements and fulfills sponsor oversight obligations. 

Implement Vendor Oversight SOPs 

Define clear vendor selection criteria and monitoring procedures. Similarly, establish TMF oversight mechanisms to ensure its accuracy and currency. These aspects should be outlined in your TMF Plan to maintain standards aligned with regulatory requirements. 

Consider Expert Assistance 

For companies seeking to develop a tailored clinical compliance program, consider engaging services like Just in Time GCP’s QMS gap assessment. Their experienced team can conduct a comprehensive evaluation of your current state and help chart a roadmap aligned with your organizational needs. 


Crafting an appropriately sized clinical compliance program and quality management system is pivotal for small pharma and biotech companies. By following these steps and seeking expert guidance when needed, you can navigate regulatory complexities with confidence and ensure adherence to the highest standards of quality and compliance. 

For further information on creating a right-sized clinical compliance program, reach out to us at info@justintimegcp.com. Let us alleviate the burdens of GCP compliance, allowing you to focus on advancing your research endeavors. 


Europe.eu ICH E6 (R3) Guideline on GCP


By Donna Dorozinsky, Founder and CEO

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