FSP for Biotech

A Functional Service Provider (FSP) model

Functional Service Provider models have long been associated with large pharma companies, outsourcing departments, and off-shoring practices that emphasize low cost over quality and scale over thoughtful program management.

At Rho, we’ve re-imagined the FSP model with our biotech clients in mind.

We don’t use a one-size-fits-all approach to FSP, and instead will work with you to develop a bespoke model that will be right-sized for your development program. We provide all the benefits of a traditional FSP model—flexibility, efficiency, and consistency—along with access to biometric tools and insights usually available only to larger pharmaceutical companies, coupled with a commitment to your program that only a CRO like Rho can provide.

Outsourcing program-level biometrics to our teams ensures your development program is in the hands of industry-leading experts with a 35+ year history of excellence in biometrics and a proven track record of successful product approvals and virtual clinical trials. Your program will benefit from our analytical and integrated approach to data collection, management, and analysis, which provides data-driven, real-time insights essential in guiding both clinical trial execution and marketing application development.

Learn how our customized FSP services can benefit your clinical development program and marketing applications.

network

35+

Years of Experience in Biostatistics and Statistical Programming

200+

Clinical Protocols Adhering to CDISC Standards

17

Approved Products

Functional Clinical Support Services & Our Expertise

  • Biostatistics and Statistical Programming
    • 35+ years of experience providing biostatistics and statistical programming services
    • Large staff of highly qualified personnel, many of whom have advanced degrees
    • Experience in numerous indications across most therapeutic areas
    • Our biometrics experts understand regulatory expectations and requirements for approval, which informs trial design, statistical analysis planning, and other program-level decisions
    • Represented 30+ clients at FDA meetings in the last 3 years
  • Data Management
    • 30+ years of experience providing data management services
    • Medidata Rave® Study Builder Accreditation
    • Flexible, fast, and accurate database set-up and design
    • Sophisticated methods and tools for data review which scale to trials of all sizes and support risk-based monitoring, central monitoring, off-site monitoring, and targeted site data verification (tSDV)
  • Regulatory and Medical Writing
    • Extensive experience with electronic IND, CTA, IDE, and marketing application submissions in a wide range of indications, including 30+ marketing applications in the last 5 years and 17 approved products
    • Our regulatory experts have submitted dozens of Orphan Drug Applications, developed successful Accelerated Approval programs, and secured several Priority Review applications
    • We have a 100% technical acceptance rate with FDA
    • Recently received the CRO Leadership Award for Regulatory from Life Science Leader Magazine

Rho’s Statistical and Programming team has consistently provided high quality deliverables, with an eye for detail that is both comprehensive and insightful. The team’s dedication has been evident in each step of the process and the results have proven to be exemplary by any standard. We appreciate all of Rho’s hard work and value our partnership with them.

Sam Wilson, Director Biostatistics, Frequency Therapeutics

Tips for Selecting an FSP Provider

In this article, our experts provide 4 tips for selecting a CRO to provide FSP services.