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Rho, Inc.

Description: 

Background

Rho, a contract research organization (CRO) located in Chapel Hill, NC, provides a full range of services across the entire drug development process.  For more than 25 years, Rho has been a trusted partner to some of the industry’s leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations.  Our commitment to excellence, our innovative technologies, and our therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience. 

 

We are a privately held company, have no long term debt, and have been profitable every year since our founding in 1984.  This provides stability for our customers and employees and allows us to make decisions with a long term focus which benefits both Rho and our clients.

 

Experience

Rho has conducted more than 1300 studies with more than 17,000 sites and 300,000 subjects in all phases of development.  Our decades of experience have led to numerous publications in some of the most prestigious healthcare journals including Nature, New England Journal of Medicine, and The Lancet. We have interacted with more than 25 FDA divisions in the Center for Drug Evaluation and Research (CDER), the Center of Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Center for Food Safety and Applied Nutrition (CFSAN).

 

We have experience in numerous indications in all therapeutic areas and have exceptional depth in these areas:

  • CNS & Analgesia
  • Immunology
  • Respiratory
  • Influenza
  • Hematology
  • Dental/Oral Diseases
  • Immunology

 

Service Offerings

We are able to support studies through individual services, functional service provider (FSP) models, full program management, and everything in between.  Our service offerings include:

  • Pre-trial regulatory guidance
  • Pre-IND briefing packages
  • IND applications
  • Labeling development
  • Safety and IND annual updates
  • Protocol development
  • Clinical operations
  • Regulatory document strategy
  • Clinical data management
  • SAE management and narratives
  • Statistical analysis and consulting
  • Clinical project management
  • CDISC expertise
  • IVRS/IWRS
  • DSMB reports
  • Manuscripts and publications
  • Clinical study reports
  • Pre-NDA briefing packets
  • New Drug Applications (NDA)
  • BLA/MAA submissions

 

We also provide consulting at any stage of the drug development process:

  • Protocol development
  • Regulatory strategy and submission
  • Site selection
  • Patient recruitment
  • Statistical consulting
  • Data standards (CDISC, AdAM, SDTM, CDASH)

 

Interested in learning more?  Check out our website www.rhoworld.com or follow us on Twitter @rhoworld.

 

Services: 

Clinical Study Reports, Clinical Trial Design, Clinical Trial Monitoring, Data Management, Data Safety Monitoring Board Services, Project Management, Protocol Development, Regulatory Affairs/Regulatory Strategy, Statistical Services/Meta Analysis, Trial Management

Contact Information: 

Rho, Inc.
6330 Quadrangle Dr
Chapel Hill, NC, 27517, USA
Phone : 9194088000
Fax : 9194080999
Internet : www.rhoworld.com
Email : info@rhoworld.com
Contact Person : Joan Parks