Scalable Data Operations Support Services

The Client

An innovative and breakthrough biotechnology company with extensive R&D and commercialization activities, headquartered in the U.S., with global and regionalized product and development operations team.

The Challenge

The client routinely outsources its data management operations. However, due to marketplace constraints and limited access to various talents, the client had trouble finding, replacing and retaining the right resources needed to run and scale its data operations. These issues were compounded by the consistent high demands from the global portfolio development teams to deliver data for regulatory submission and strategic medical affairs (post-market and publications).

The Actalent Solution

Actalent deployed a remote North American team with the client that included a dedicated technical project manager (director level), principal data managers and other data specialist roles to support enterprise clinical and non-clinical projects.

As part of our overall solution, we built and deployed teams in the following areas:

• Clinical systems and applications support
• Programming and data systems
• Data standards and study metadata implementation
• Medical coding and safety
• TMF, biomarker, eCOA/PRO data specialist/scientist
• Central monitoring

To minimize rework, our project plan included training and knowledge transfer to ensure Actalent had a thorough understanding of the client’s quality management system (QMS), including all systems and processes necessary to conduct this work globally and support all their business units. We also provided feedback around workflow and communication processes, essential for supporting a global function with remote and virtual employees.

The Results

We partnered closely with the client to develop and share best practices in biometrics and data management operations. By working with the client’s senior management team, we ensured that all activities were completed within budget, requirements and on schedule. Given the overlap our support had with existing and new projects (e.g., large, global studies) and the need to liaise with multiple vendors and internal stakeholders, our team provided ongoing technical guidance to client personnel. This support extended to new projects, including onboarding new principal data managers to implement and oversee internal study activation processes and provide overall vendor management oversight.

Currently, we are responsible for over 60% of the client’s data operation employees, which allows us to easily scale up and down based on the needs of planned studies. Additionally, we have achieved a 91% retention rate within this FSP program, helping to maintain continuity throughout the engagement, ensure all critical technical requirements have been met and project quality and compliance were consistently maintained.