Functionally Aligned Strategic Team (FAST)

What is 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. 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.

maximize

efficiency

quality

Value

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

Services

The FAST Program

Specifically designed to complement your team and meet the needs of your study, program, or project.

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 [email protected] for more information or schedule a meeting with us at your convenience

Explore More Services

Functional Service Provision

Functional, Flexible, and Fractional. Harbor Clinical provides a broad portfolio of services across the clinical development lifecycle.

GxP Auditing

Harbor Clinical’s team of GxP auditors is available to help you plan, schedule, manage, and conduct your site/vendor audits.