Functionally Aligned Strategic Team (FAST)™
Our FAST program is a subset of our FSP outsourcing model and is designed to maximize efficiency, quality, and value in your R&D efforts.
What is FAST™?
The Functionally Aligned Strategic Team is made up of SMEs from functional areas and assigned to your study/studies exactly when you need them, at exactly the level you need, and for exactly the right duration.
The FAST Program
This program may include full FTEs and/or fractional FTEs based on the nature of the project.
The FAST program is best implemented when there is a finite and unmet need such as:
- a move from preclinical to early phase clinical research
- drafting of a protocol and updating an Investigator Brochure given feedback from a regulatory agency
- quality control of data given resource shortages at a CRO
- implementation of an inspection readiness plan
- drafting SAE narratives in support of a NDA
How it Works
A lead Strategy Advisor from Harbor Clinical will meet with you and your team to gain an understanding of the specific needs and goals.
Proposal
With that, a proposal is quickly developed and presented. Depending on the scope of the project, our FAST will be in place in a matter of days. A lead point person is assigned and, where appropriate, a governance structure is established.
Plan
We will design and propose the right level of governance for the project, bearing in mind that the FAST program may be implemented on small or large projects.
Strategy Session
Whether you’re ready to implement a FAST™ or just want to learn more about the program, one of our Strategy Advisors would be pleased to meet with you for an introductory session. Please contact us at solutions@harborclinical.com for more information or schedule a meeting with us at your convenience.