Evolution Of An Outsourced Monitoring Model

One of the world‟s largest pharmaceutical companies chose to outsource their clinical monitoring function completely. We were already the preferred provider of a mirrored model for clinical monitoring (our CRAs worked side-by-side with the sponsor„s CRAs) when the client decided to outsource completely. The sponsor wanted to retain oversight responsibilities and eliminate the function in house.

To facilitate our expanded relationship, we invested in infrastructure to support the size of the organization and improve process efficiencies. We implemented dedicated training programs and site selection, metrics/reporting and quality management over a two year period to ensure the monitoring function was truly “free standing.” Highlights of the enhancements made to the new outsourced managed model included:

• Dedicated team of 30 study start-up leads to speed the site selection process.
• Addition of the Lead CRA role to replace sponsor staff and help meet/exceed enrollment and recruitment deliverables.
• Program and individual CRA-level scorecards to measure performance, drive continuous improvement and report all performance metrics.
• A comprehensive oncology certification training program for monitors who had previously specialized in other therapeutic areas.
• Technology solutions for capacity planning and forecasting, centralized resourcing site-level and protocol-level databases.
• Dashboard views to manage timelines/deliverables and capture expenses
• A quality management process, including oversight, training, quality review and Corrective Action and Protective Action (CAPA) activities. A quality trend analysis workgroup identifies and tracks corrective actions, quality reviews or regulatory inspections and provides recommendations on a quarterly basis.