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Accelerating Study Start-up with FSP
Lessons learned from regulatory and start-up functional service provider engagements
Dec 02, 2024
Study start-up time – the interval between site identification and completion – is a vital step that sets the tone for the entire clinical trial. Elements of site activation include contract negotiation and execution, regulatory and ethics submission and approval, import/export operations, and site preparation and activation.
Overall clinical trial complexity continues to increase, which may challenge the expertise of sponsor companies, including ones that acquire new assets or enter new indications and therapy types. Complex protocols may cause increased burden for patients and caregivers, creating problems in patient recruitment and retention. Use of technology may reduce the patient burden, enabling remote interactions with healthcare providers, as in decentralized clinical trials. However, technology may add to the burden for sites, which may have to manage many different platforms for different sponsors and trials, diverting resources away from core trial-related activities.
OVERVIEW OF SERVICES IN-SCOPE FOR FUNCTIONAL SERVICE PROVIDER (FSP) REGULATORY AND START-UP (RSU) ACTIVITIES
Site activation – which involves bringing a site to the point where it is ready to recruit patients – includes the following activities:
- Site ID support, including CDA negotiation and execution
- Contract negotiation and execution, with negotiation of study budgets and contracts to compensate a site for research costs
- Regulatory and ethics submission and approval, including preparation of submission packages for regulatory authorities and ethics committees
- Import/export operations, including preparation of import/export license applications for drug and material shipment
- Site preparation and activation, with completion of all activities required for a site to be enrollment-ready