Functional Service Provider (FSP)
Ockham’s FSP model offers clients Data (SAS® / Statistics / Data Management) and Clinical (Clinical Research Associates/Monitoring, Medical Writing, PVG) – typically based in Ockham offices. Fixed-bid or Time-and-Materials (T&M) pricing models are available. Dedicated, flexible teams allow longer-term relationships with research-critical personnel and eliminate co-employment. These functional teams provide clients with fixed deliverables under contract that are:
- Customized – able to fit client requirements by education, therapeutic area, and experience
- Flexible – operating under the client’s or Ockham’s Standard Operating Procedures (SOP)
- Dedicated – and, thus, totally focused only on the client’s needs
Services Include:
- Clinical Project Management
- Clinical Monitoring
- Biostatistics
- Pharmacovigilance
- Data Management
- Statistical Programming
- Medical Writing
- CDISC Mapping
Rapid Stat
Crunched for time? You’re not alone. The pharmaceutical and biotech industries often lend themselves to aggressive timelines to meet your company’s needs. Ockham understands and values the importance of timely and accurate reporting of your trials, which is why we offer an alternative to the standard deliverable metrics.
Ockham is able to offer in-house, around-the-clock coverage and production of statistical summaries and analyses on a timeline that meets your internal reporting needs. By aligning a team of experienced personnel dedicated solely to your project, we can significantly reduce the duration of the production period, providing the same concise, high-quality product as in our standard production unit.
Creative Problem Solving
Ockham leverages its core competencies to complement a rapidly growing functional outsourcing practice.
Dedicated Teams with a Vested Interest in Your Success
Ockham dedicates a team of high-quality, experienced clinical professionals to help meet the client’s needs.
Uncommon Experience – Certain Value
Ockham has accumulated extensive experience supporting pharmaceutical, biotechnology, medical device and CRO companies since 1992. Through a large database of pre-screened clinical professionals with whom Ockham enjoys long-standing relationships, Ockham can quickly build initial teams for the client, and re-scale, when necessary, as projects progress. The continuity of teams from study to study creates efficiencies that enable Ockham to deliver the cost-effective results clients expect.
Core Competencies
Clinical
- Clinical Monitoring
- Clinical Study Management
- Project Management
- Medical Monitoring
- Medical Writing
- Independent Auditing
- Investigator Site
- Vendor Site GCP, GLP, GMP 21
- CFR Part 11
Statistical Analysis
- Statistics
- SAS Programming
Data Management
- Project Staffing
- Data Entry