If your company is preparing to launch a new drug or medical device, it’s important you have a team of experts supporting you every step of the way. Considering the high costs and amount of risk involved, outsourcing key, strategic components of the work to a Functional Service Provider (FSP) can free up time and help you better allocate resources.
Still, it’s critical to choose a partner with aligned therapeutic and subject matter expertise as well as an ability to accommodate the parameters of your study, program, or project. Instead of selecting a big-name partner and hoping for the best, why not build a relationship on a foundation you can trust? That’s exactly where Harbor Clinical comes in. Our Functionally Aligned Strategic Team (FAST™) has the knowledge, skills, and expertise to get the job done.
What is the FAST program?
At Harbor Clinical, the FAST program is a subset of our FSP outsourcing model. Specifically, it’s designed to maximize efficiency, quality, and value, in your research and development efforts.
When you enroll in the FAST program at Harbor Clinical, you gain access to a Functionally Aligned Strategic Team composed of experts in the functional areas you need when you need them and at the precise level of dedication. These functional areas include:
● Quality Assurance
● Vendor oversight
● Medical Monitoring
● Medical Writing
● Clinical Operations
● Regulatory
● Strategic Development
● Biometrics
No two FAST teams are exactly alike. To ensure you achieve your goals, we select a group of professionals who complement your efforts. Depending on your needs, the team might include full-time and/or fractional (i.e., part-time) experts.
When should a company consider using the FAST program?
At Harbor Clinical, we recommend the FAST program in situations where sponsor companies have finite and unmet needs. Examples may include a small company entering the clinic with near immediate development needs; a company seeking to grow quickly but needing support as they implement long-term hiring strategies; or perhaps a larger company that simply needs staff augmentation during periods of competing deliverables.
We regularly use the FAST program to help teams:
● Make the transition from the preclinical to early phases of clinical research
● Draft their study protocols
● Update their Investigator’s Brochure
● Implement inspection readiness plans
● Draft SAE narratives in support of an NDA
● Prepare Investigational New Drug (IND) applications
The FAST program also provides quality control of your data, ensuring nothing falls through the cracks, even if you’re short-staffed.
How does the FAST program work?
If you elect to enroll in the FAST program, we select a lead Strategy Advisor from our experienced in-house staff. Before moving forward, the Advisor meets with you and your team to gain an understanding of your specific needs and goals.
After asking a series of thoughtful questions and gathering the necessary information, your Strategy Advisor drafts a proposal. We prepare most proposals within a few days, but it may take up to a week, depending on the scope of your project.
Once your lead Strategy Advisor finalizes the plan, they present it to you and your staff in full. During that meeting, we assign a lead contact and establish a governance structure (when appropriate). No matter the size or scope of your project, we’re confident the FAST program will make your job that much easier.
Take the First Step: Request a FAST Program Strategy Session
If you’re in the early stages of planning a Phase I clinical trial, now is the perfect time to schedule a FAST program strategy session. Whether you’re on the fence or ready to pull the trigger, one of our Strategy Advisors would love to meet with you and your team for an introductory session.
To schedule your FAST Program strategy session, click the calendar link below. A member of our FAST Strategy Team will meet with you at your convenience. Thanks for taking the time to learn more about our FAST program –– we look forward to hearing from you!
