Clinical Development

End-to-end comprehensive biotech clinical development strategies and expertise

Rho’s integrated team of regulatory, clinical, CMC, biometrics, data standards, and regulatory operations experts provide experience-based clinical development strategy 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 global clinical research development missteps along the way.

From program strategy through clinical trials and marketing applications, Rho has a proven track record of pharmaceutical research and 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.

Seeking guidance on identifying challenges and de-risking your decentralized trial?

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Integrated Services and Discipline-Specific Consulting

Rho’s cross-functional and collaborative team of experts make Rho the ideal partner CRO for clinical development, providing a comprehensive range of services covering end-to-end drug development services, 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.

Keep reading for a comprehensive list of Rho’s clinical trial services for drug development.

Learn how our regulatory experts can provide experience-based clinical development strategy and execution to accelerate development of your product. We proudly invite you to experience Rho.

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Our Expertise

Rho routinely prepares and submits

4-5

investigational trial applications (INDs, IDEs, CTAs) each year

Represented

30+

clients at FDA meetings in the last 5 years

Expertise engaging with all 7 offices and

27

divisions in the Office of New Drugs (CDER) + the Office of Tissues and Advanced Therapies (CBER)

Clinical Protocol Authoring Guide

Read this article to understand the 10 essential steps to authoring a protocol synopsis and ultimately the clinical study protocol.

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