To help the client overcome these challenges, INC Research/inVentiv Health formed a strategic partnership with the biopharmaceutical company and took over responsibility for all of its trial-level clinical data management activities in the United States. Using a functional service provision (FSP) team, INC Research/inVentiv Health employed the following to help the sponsor achieve its objectives:
Effective utilization of resources
INC Research/inVentiv Health hired the experienced personnel, previously employed by the biopharmaceutical company, to ensure that it retained knowledge vitally relevant to the clinical trial and therapeutic area. This strategic decision enabled the client to help place employees in new jobs and provided INC Research/inVentiv Health with well-informed and talented staff members.
INC Research/inVentiv Health managers moved quickly to ensure the efficient transition of data management activities to the FSP team. They opened a new office in close proximity to the client’s study team. Additionally, INC Research/inVentiv Health managers provided the FSP team with ongoing support and training to successfully accomplish its responsibilities, which included the management, coordination and delivery of clinical trial and analysis datasets.
The INC Research/inVentiv Health team managed outside vendors on behalf of the client, ensuring the high quality of the project’s deliverables and freeing up the sponsors’ internal study team to tackle more strategic work.
With the right people properly trained and in place on the FSP team, INC Research/inVentiv Health guided the biopharmaceutical company through the process of moving to their data management work to INC Research/inVentiv Health with a deliverables-based model.