Case Study

Oversight and Line Management for On-Site Clinical Study Teams

A biopharmaceutical company fielding a large volume of work was helped by EASi Sciences to secure FDA approval for a critical study and implement a streamlined process for additional work.

The client and challenge
This client, a multinational biopharmaceutical company, is dedicated to providing life-changing therapies and treatments for cancer patients.

Our client was outsourcing portions of their clinical trials to a Functional Service Provider (FSP). The FSP was struggling to provide the expected levels of HR and line management oversight necessary hire and retain senior-level data managers to complete clinical study activities.

With several new studies expected to launch throughout the upcoming year, and its current FSP delivery model struggling to meet current business demands, the client decided to move their clinical trial activity in-house. This change would require them to build an internal support structure to manage and retain the current study resources, be prepared to quickly hire new resources when additional studies launch, and accommodate the build-out and implementation of a new data management system to process and analyze the study data being collected.

The EASi solution
EASi designed a flexible and scalable service model designed to accommodate the clients evolving business needs by outlining specific project deliverables in SOWs. Our service model included a dedicated Program Manager (PM) to provide the necessary HR and line management oversight while keeping the overall technical control with our client. We developed employee performance reviews that are conducted semi-annually to improve retention and allow resources to focus on quality outputs to ensure job requirements were being met on-time.

We developed a team of qualified resources by leveraging Aerotek’s robust recruiting strength and access to specialized talent within the clinical industry. This ensures we have access to talent quickly when new studies are launched.

Together with the client, we developed a customized governance model and communication plan that outlined a monthly call schedule, and semi-annual performance management meetings to review the work outputs from our resources and provide consistent updates regarding the health of our partnership.

The results
As a result of our service model, our client gained the necessary approval from the U.S. Food & Drug Administration (FDA). By implementing a resource management team as well as recruiting and hiring the data management employees, we were able to help the client meet all project timelines and milestones. Most importantly, the client was able to launch the database software ahead of the lock-out by more than two weeks. Furthermore, we were able to help the client expand their talent pipeline for clinical trials, which ensures they have the resources in place to support future trials.

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