Client was expanding the number of client trials it needed to support over the next three years. Currently they were supporting their activities via spreadsheets and word documents.

Manufacturing

OBJECTIVE

Client was expanding the number of client trials it needed to support over the next three years. Currently they were supporting their activities via spreadsheets and word documents. Based upon their growth plans, the needed to determine what systems they should consider and when they needed to support the various activities and functions.

SOLUTION

  • This was an assessment that needed to be conducted in a timely manner as the client had a clear financial funding timeline. This roadmap was an important element in securing that funding.
  • Bring together key stakeholders throughout the major functions of the organization. Develop initial timeline, including trial sizes, data constraints, filings, and geographic markets. Overlay technology considerations to build a dynamic roadmap.

BENEFITS

Developed a draft 3-year roadmap that supported their financial and business targets. Obtain an approach to maintain data compliance while allowing the greatest flexibility and minimal IT overhead.

Key Project Elements

Assessment to automate manual processes

Time of the Essence

Identify Key Stakeholders and Sponsors

Align technology to build dynamic roadmap

Developed Strategic Roadmap for Gene Therapy Clinical Trials