Demand in Clinical Research & Development for expert resources with global reach is at an all time high. An effective way for sponsors to supplement their staff is through a flexible FSP outsourcing model that provides real-time access to highly specialized resource team(s) for well-defined business services.
A partner you can count on
Why BioPoint?
Our expert consultants integrate and collaborate with the client’s internal staff, with the sponsor typically providing governance and central oversight. A dedicated BioPoint engagement manager works closely with the sponsor to scope each engagement and assemble the most qualified resources based on a thorough understanding of each client’s unique business needs. This central point of contact will also coordinate necessary onboarding, client specific training, monitor project deliverables and performance metrics throughout the partnership.
BioPoint’s FSP outsourcing strategies focus on a true partnership, increased outsource flexibility, engagement oversight, and ultimately increased efficiencies to reduce cost.
Benefits of BioPoint’s FSP Program
- Select which specific tasks or functions to outsource
- Minimize the time required to start projects
- Focus on provision of best in class resources for specific functions
- Provide focused, cost-effective use of experienced professionals
- Simplify complex processes with quality measurements
- Scale resources without affecting internal headcount
- Allow Pharmaceutical organizations to focus on their core competencies
- Manage multiple functional experts through a central point of contact
- Discounting based on increased volume
BioPoint FSP – Areas of Expertise:
- Drug Safety & Pharmacovigilance
- Regulatory Affairs
- HEOR Market Access
- Quality Assurance
- Clin Ops / Clin Dev
- Medical Review
- Safety Surveillance / Signaling
- Safety Reporting
- REMS/RMP
- PV Epidemiology
- Regulatory Strategy
- Advertising & Promotion
- Labeling
- CMC
- Medical Writing
- Observational Study Design
- Economic Modeling
- Global Value Dossiers
- Pharmacoepidemiology
- Pricing & Reimbursement
- GxP Internal & External Audits
- PV Audits
- Inspection Readiness
- SOP Development
- QMS
- Clinical Program Management
- Regional Monitors
- Clinical Data Management
- Biostatistics
- GCP Compliance
- Clinical Development Strategy
- Clinical Development MD Support
- Clinical Development Scientist Support
- Protocol Development
- TPP Development