FSP for Biotech

An FSP model designed for biotech

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

FSP 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

Tips for Selecting an FSP Provider

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