Driving quality in clinical trials through an Oversight Capability Maturity Model
The Avoca Quality Consortium (AQC) has developed an Oversight Capability Maturity Model (OCMM), a model designed to assess organizational capabilities for oversight of external service providers in both regulated and non-regulated scenarios. A first-of-its-kind for the Pharmaceutical R&D industry, the OCMM enables organizations to manage internal capabilities for provider oversight and identify weaknesses. This process will help organizations manage providers’ ability to deliver on time, on budget and with expected quality, which is increasingly important to ensure ICH E6(R2) compliance.
The OCMM model has five levels of maturity, and addresses ten critical dimensions for Oversight Capability. Each dimension is linked to a wide range of AQC leading practice guides, tools and templates. For example, one of the dimensions of oversight capability is governance. Many organizations struggle with developing effective governance constructs such as committee charters. Having governance charters in place helps to drive effective joint collaboration to better ensure successful delivery on the goals and objectives of the partnership. The model links users to sample governance committee charters, such as an Executive Governance Committee Charter.
The outcome of this OCMM model is a matrix with 50 detailed descriptions of oversight capability (5 levels and 10 dimensions) that can be used to assess your organizational maturity level and to advance it to higher levels.
About the Avoca Quality Consortium (AQC)
The AQC is an industry-wide collaborative that brings together industry stakeholders to improve quality management in outsourced clinical research. The Consortium develops progressive solutions to some of the greatest challenges faced in clinical research.
The AQC provides our 70+ member companies with access to a quality oversight framework, which includes 300+ guidelines, tools, templates, and processes across 8 key categories (Governance, Technical Oversight, Process Oversight, Communication, Oversight Leadership Requirements, Metrics/Analytics/Technology, Roles/Responsibilities, and Proactive Risk/Opportunity Management).
If your company is an AQC Member, and you would like more information on accessing these tools, please contact Caryn Laermer. If your company is not a Member, and you are interested in exploring membership to the AQC, please contact Josh Seltzer.
About the Avoca Group
The Avoca Group is an integrated research and consulting firm providing survey research, consulting services and training in the areas of clinical trial outsourcing, business development, strategic alliances and client service to help solve complex clinical trial challenges, improve business relationships, improve quality, and optimize efficiency in the oversight and execution clinical of clinical research. Founded by industry veteran Patricia Leuchten in 1999, the company works exclusively in the health care industry and has a focus on relationship management.
To find out more on how Avoca can help, please contact Beth Listhaus.