Clinical Development

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.

Seeking fast development and approval for your COVID-19 related product?

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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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Featured Content

White paper

Accelerating Regulatory Product Development and Approval for Drugs and Biologics in the US

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White paper

Seven Essentials for Successful Drug Development

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Blog Post

Is a Target Product Profile Worth the Effort?

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