Case In Point
Long-Term FSP Partnership for Biostatistics and Programming
About Client
Since 2008, Everest has served as a preferred vendor for biostatistics and programming services for a global pharmaceutical company. The client has gone through three large corporate acquisitions, and the relationship has remained strong throughout. Everest provides flexible, high-quality support through both project-based work and FSP (Functional Service Provider) staff augmentation models.
Challenge
- The client required qualified, stable, and efficient teams to consistently deliver top-tier statistical and programming outputs across multiple study phases and regulatory functions
- Team members needed to operate within the client’s systems and SOPs, including virtual desktops and statistical computing environments
- Support was needed across a wide range of deliverables and timelines, including:
- Clinical study reports (CSRs)
- SDTM, ADaM, and TFLs for Phases I–IV
- DMC/DSMB support
- Regulatory submissions (ISS, ISE, eCTD packaging)
- Support for global regulatory agencies (FDA, EMA, PMDA, NMPA, Health Canada)
- Post-submission support, Investigator’s Brochures, DSURs, and publications
- The client also needed to scale quickly and manage urgent, unplanned work without compromising quality or increasing overhead
Solution
Everest implemented a hybrid delivery model, combining dedicated FSP resources with project-based teams:
- Built a core group of subject matter experts fully trained on sponsor systems, processes, and standards
- Scaled operations to support a growing volume of work: more than 120 projects supported since Jan 2023
- Deployed 80–100 statisticians and programmers across both models
- Teams operate directly within the sponsor’s environment and follow sponsor SOPs
- Integrated Everest’s third-level quality control (QC) checks and elevated internal quality procedures to ensure rigor in deliverables
Results
- High retention and stability of Everest teams, ensuring continuity and reduced onboarding time
- Achieved a reputation for:
- Flexibility in managing urgent and unplanned work
- High-quality deliverables across all phases and regulatory requirements
- Expedited regulatory support for major submissions
- Low overhead costs, with project management averaging just 5–6% of total budget
- Client continues to expand Everest’s scope based on performance and reliability
