End-to-end comprehensive clinical development expertise and consulting
Rho’s integrated team of regulatory, clinical, CMC, biometrics, data standards, and regulatory operations experts provide experience-based guidance and execution to accelerate development of your product.
Our expert teams can plan, coordinate, and execute each clinical, non-clinical, CMC/Quality, and regulatory activity for your product, balancing risk against accelerated timelines by optimizing regulatory interactions and strategically running the right studies at the right time to achieve milestones with maximum efficiency. We allow you to focus your resources more effectively and get your products to patients faster while preventing costly development missteps along the way.
From program strategy through clinical trials and marketing applications, Rho has a proven track record of drug development success in numerous products across a wide range of therapeutic areas. Playing a vital role in 17 product approvals in the last 5 years, Rho continues to demonstrate its unique ability to see the finish line from the starting block.
Integrated Services and Discipline-Specific Consulting
Rho’s cross-functional and collaborative team of experts provide a comprehensive range of services covering end-to-end product development, guidance, execution, and support, including:
- Creation and implementation of a strategic Integrated Product Development Plan
- Development of the Target Product Profile
- Product management through full life cycle
- Coordination of concurrent activities to accelerate development timelines
- Complete IND/CTA/IMPD support
- Regulatory meeting attendance and briefing package preparation
- Design, implementation, and conduct of clinical studies (Phase I-IV)
- Comprehensive marketing application support (NDA, BLA, PMA)
- Proactive risk management/mitigation
In addition, Rho frequently provides targeted consulting engagements in any discipline, including regulatory strategy, nonclinical development, CMC, clinical development, data management, biostatistics, and data standards.
David Shoemaker, Ph.D.
Senior Vice President, R&D
Jack Modell, M.D.
Vice President and Senior Medical Officer
Kevin Barber, Ph.D.
Vice President, Regulatory Strategy & Submissions
Vice President, Clinical Operations
Chief Strategist, Regulatory Biostatistics and Data Standards
Chief Strategist, Biostatistics & Protocol Design