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. 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.
Rho offers FSP services in the following areas:
- Biostatistics and statistical programming
- 30+ 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 standards and CDISC
- Industry leader in formulating and adopting CDISC standards for the past 20 years.
- Rho experts have contributed to the development of several aspects of the current standards and helped speed their arrival to industry
- Implemented CDISC standards across a wide spectrum of therapeutic areas and FDA review divisions, including more than 200 clinical protocols and 40 US and ex-US marketing applications
- Our teams use the same software as FDA to manage CDISC compliance, clinical data quality, and submission readiness
- 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
- 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
"Working with Rho continues to be a wonderful and productive collaboration."
"I have so enjoyed working with Rho. I've been in this business for 13 years, and I have to say that Rho has been the BEST CRO I have ever worked with."
Rho offers tips for choosing a strong FSP partner in this article published in International Clinical Trials.