FSP for Biotech

FSP for Biotech

Combining the expertise and stability of a large CRO with the dedication and agility of a small CRO, Rho has positioned itself as an industry leader providing right-sized biometrics services and functional support for over 40 years.

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.

But not at Rho. Here, we’ve reimagined the FSP model with biotechs top of mind.

Instead of the typical one-size-fits-all approach to FSP found at large CROs, we work with you to develop an FSP model that fits your development program. We provide all the benefits of a traditional FSP model along with unparalleled access to biometrics tools and insights usually only available to larger pharmaceutical companies. Plus, because we focus on the small to mid-size pharma space, we understand the importance of being flexible and responsive to the needs of smaller companies. And as a result, our FSP clients stay with us for the long haul.

In the past 5 years, ~95% of our biometrics FSP sponsors have expanded their partnership with Rho.

By outsourcing program-level biometrics to our teams, you’ll ensure that your development program is in the hands of industry-leading experts with over 40 years of biometrics expertise and a proven track record of successful product approvals and virtual clinical trials. Additionally, your program will benefit from our analytical and integrated approach to data collection, management, and analysis – providing data-driven, real-time insights essential to guiding both clinical trial execution and development of marketing applications.

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

Together, let’s customize a FSP model which accelerates the development and execution of your clinical program and marketing applications – bringing relief to those in need faster and more effectively.

team photo

Our Expertise

40+

years of expertise in Biometrics and Statistical Programming

Supported

17

approved drugs over the last 5 years

200+

clinical protocols adhering to CDISC standards

Expert Functional Support for Clinical Trials

  • Biostatistics and Statistical Programming
    • 40+ years of experience providing biostatistics and statistical programming services
    • 80+ biometrics personnel on staff (~60 biostatisticians and programming experts / ~20 data managing experts)
    • 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 alone.
    • Consistent and experienced teams (each member has 10+ years of project management experience)
  • Data Management
    • 40+ 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
    • Recognized last year with 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.

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