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 support for over 35 years. With over 100 biometrics personnel, across data management, biostatistics, data standards, and statistical programming, we have the capacity and depth to provide consistency throughout your development program, from product development through marketing application, advisory committee, and approval.
At Rho, we keep your end goal top of mind.
It’s not just business to us, we understand that there is more than one solution. Instead of the typical one-size-fits-all approach to clinical trials found at large CROs, we work with you to develop a biometric support model that fits your development program. Whether you need support on one or multiple projects, dedicated full-time equivalent support or support within Rho’s full-service offerings, or somewhere in between, we provide unparalleled access to biometrics tools and insights not typically offered by a smaller CRO. We understand the importance of being responsive to the needs of your company. As a result, our clients stay with us for the long haul.
In the past 5 years, 95% of our biometrics clients have expanded their partnership with Rho.
By outsourcing biometrics to our team of professionals, you’ll ensure that your project is in the hands of industry-leading experts with a proven track record of successful projects. Additionally, your project will benefit from our analytical and integrated approach to data collection, management, and analysis – providing data-driven, real-time insights essential to guiding both project and development of marketing applications.
We understand the nuances and intricacies of FDA guidance and expectations, preparing and analyzing data for product approval. As a result, we have a 100% technical acceptance rate with the FDA. With us, there is no need to handoff to another CRO for NDA submissions which results in a faster timeline to market.
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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 Biometrics support model which accelerates the development and execution of your project, program and marketing applications – bringing relief to those in need faster and more effectively.
years of expertise in Biometrics
approved drugs over the last 5 years
of our biometrics clients have expanded their partnership with Rho
Expert Functional Support for Clinical Trials
- 35+ years of experience providing data management services
- Experience in numerous indications across therapeutic areas and phases
- Flexible, fast, and accurate database set-up and design in Medidata Rave
- Work with multiple EDC systems and third-party vendors
- Integrate data across systems to have a full account of subject’s data
- 35+ years of experience providing biostatistics
- Experience in numerous indications across most therapeutic areas
- Our biostatistics experts understand regulatory expectations and requirements for approval, which informs trial design, statistical analysis planning, and other program-level decisions.
- Client representation at FDA meetings
- Consistent and experienced teams
Data Standards and Statistical Programming
- 35+ years of experience providing data standards and statistical programming services
- 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
Estimands: An insight into the new framework
In this blog post, our experts discuss the four attributes that characterize an estimand and how they can be used to answer key clinical questions in your trial.