FSP models can reduce costs without compromising quality
Rho is an experienced functional services provider (FSP) with decades of experience working with sponsors in an FSP model. In addition to having industry-leading experts to offer in the areas of biostatistics, data standards, and regulatory and medical writing, we understand what it takes to make these important and long-term relationships work.
We strive to become a true extension of your team, ensuring continuity, consistency, and an understanding of your systems and processes. Our FSP model provides an easy and flexible way to scale up and avoid the expense of underutilized resources, and we work to reduce your level of oversight as the FSP partnership matures. We also value long-term planning and open communication, and we seek to develop partnerships with companies that share our values, as strong relationships are critical to making FSP programs work.
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
- 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
- Data management
- 30+ years of experience providing data management services
- Medidata Rave® Study Builder Accreditation
- Flexible, fast, and accurate database set-up and design
- 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
- 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.