Reimagining Quality Management for a CRO
In this case study, learn how Clarkston Consulting supported quality management for a CRO to achieve cost savings while maintaining the highest standards of quality. Read a synopsis of the project below or download the full case study.
Download the Quality Management for a CRO Case Study Here
Following a recent spin-off from a larger clinical development organization, our client, a global Contract Research Organization (CRO), sought to reassess its Quality Assurance (QA) strategy and operating model. Specializing in Phase I-IV clinical trial management, patient access, and technology solutions for pharmaceutical and biotechnology companies, the client aimed to ensure its QA function was fit-for-purpose in a more autonomous environment.
The engagement focused on empowering individual departments, from quality to operations, to take greater ownership of quality management while simultaneously enhancing efficiencies, reducing redundancies, and eliminating lower-value activities within the QA function.
To reimagine quality management within their organization, Clarkston was engaged to:
- Assess the organizational structure and operating model to align with the CRO’s strategic goals.
- Evaluate the Quality Management System (QMS) to identify opportunities for optimization.
- Deliver actionable recommendations to streamline processes, reduce costs, and enhance quality oversight.
Clarkston conducted a holistic assessment of the QA organization using both quantitative and qualitative methods, including stakeholder interviews with QA and departmental leadership; in-depth reviews of key quality data to include corrective action and preventative action (CAPA) volumes, non-conformance issues, SOPs, and audit findings; and the analysis of the existing organizational structure, including Span of Control (SoC) and role alignment.
Our assessment revealed varying levels of effectiveness across departments, with structural gaps between the current operating model and the desired end-state QA function. One of the most significant challenges was the total cost of quality, including rework, audit findings, and quality events impacting customer timelines and perceptions.
Through a collaborative approach, Clarkston helped the client gain critical insights into their existing structure and develop a strategic roadmap for a more efficient, cost-effective, and high-performing QA organization. Read the full case study to explore how Clarkston partnered with this CRO to elevate quality while driving operational efficiencies and cost savings.
