A Consistent Approach to Risk Based Quality Management: Collaboration is Key

Developing, executing and overseeing clinical trials is a complex process. Yet it is essential to gain reliable evidence from clinical trials to inform decisions about trial participants’ safety and the reliability of trial results. As clinical trials have become more complex, sponsors must identify proactive ways to incorporate quality into study design, rather than taking a reactionary approach of only monitoring quality during clinical trials.

While there’s an abundance of quality management guidance from various organizations, including the International Council for Harmonization and the FDA, historically each sponsor has interpreted and implemented this guidance differently. This variation has led to inconsistent and potentially inefficient approaches.

To support consistent industry-wide practices, ACRO’s CRO Forum has now released Risk Based Quality Management (RBQM) – A Collaborative Approach to Holistic Clinical Trial Oversight. The paper is aimed at ensuring greater collaboration and efficiency through a shared vision of risk based quality management (RBQM). ACRO’s cross-company team of subject-matter experts authored the piece to share perspectives that will help sponsor organizations create a RBQM system in partnership with CROs and technology vendors. When sponsors, CROs and vendors can work from a shared, proactive plan, they can then tailor their oversight strategy to support improved quality and safety of clinical trial execution.

Creating a system-based, holistic, risk-based approach to clinical trial management and oversight supports key decision-making activities and reduces clinical trial complexity. Together, sponsor companies and CROs must work closely to implement the following four steps of risk-based quality management:

  1. Plan: Assess the risks and develop a monitoring strategy. This includes determining who will be responsible for quality oversight and whose standard operating procedures to follow, which should be determined as early as possible—ideally during the request for proposal stage. Sponsors should consider the pros and cons of each approach, whether the sponsor fully outsources the oversight to a CRO, manages it all internally, or takes a hybrid approach.
  2. Do: Perform monitoring activities according to the agreed-upon protocol, documenting and sharing information appropriately along the way. This should include risk-based monitoring to pinpoint with the greatest speed and accuracy the right information needed to protect patients and secure quality data much faster.
  3. Check: Review leading indicators of quality to inform monitoring activities.
  4. Act: Adjust monitoring activities in response to quality indicators.

The clinical trial community has a responsibility to get quality management right; the livelihood of patients’ who rely on our life-saving therapies depends on it. That’s why we need to work together through a collaborative oversight model to achieve the best results. ACRO members invite sponsors to join us in this shared vision for the future of clinical research.

Download “Risk Based Quality Management (RBQM) – A Collaborative Approach to Holistic Clinical Trial Oversight” to read the paper.

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