Case Study R&D
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RECORDS MANAGEMENT OPTIMIZATION

Client Challenge

Effective records management requires establishing a well-defined process for retaining and appropriately disposing essential records when there is no legal or contractual obligation or other internal need to retain. The client, a large pharmaceutical company, was seeking support to assess and optimize their records management program across Clinical, Regulatory, Quality, Medical Affairs, and Safety business functions.

Red Nucleus Solution

Implementing a records management process in a complex landscape of systems and users requires robust understanding of the current state needs. A cross-functional assessment was performed to document the records management process and evaluate the current state across all the client’s R&D, RA, and Safety systems and platforms. The work accomplished provided the client with the following:

  • Development of a Records Management Process Guide capturing the “to-be” business process for records management and definition of process roles, responsibilities, and activities
  • Mapping of current state users, systems, and information flows pertaining to records management in a Systems Landscape
  • Compilation of the client’s Records Inventory scope based on stakeholder interviews and application of their respective Records Retention Schedules
  • Creation of a 2-3 Year Optimization Roadmap outlining the strategic plan for the priority areas of improvement

Value

Red Nucleus successfully assessed over 40 business sub-functions within Clinical, Regulatory, Quality, Medical Affairs, and Safety business functions, yielding 1,400+ identified types of records pertaining to the Records Management process archived across 40 repositories. Findings from the assessment were synthesized into a 2-year optimization roadmap detailing the strategic plan for 5 critical initiatives in ensuring long-term compliance. Each initiative was tailored to allow all functional areas to have a robust understanding of records management, laying the foundation for a solid records management process and approach from an enterprise level as well as a functional stakeholder level.