contract-research-organization-cro-cover-photo

Contract Research Organization (CRO)


What Is a CRO?

Contract Research Organization (CRO) is an organization that provides services to the sponsor or sponsor-investigator.

From FDA 21 CFR 312.3 under Definitions and Interpretations:

Contract research organization means a person that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the Food and Drug Administration.

FDA 21 CFR 312.3

CRO Services

CROs can perform all the work involved in clinical trial, from pre-clinical R&D studies through all phases (Phase I to IV) of clinical trials. Some examples of services may include:

  • Protocol development
  • Clinical trial management
  • Site monitoring
  • Quality assurance
  • Data analysis
  • Medical writing
  • Regulatory filings and liaison

Services are done through contractual agreement called Transfer of Obligations. Although the services are outsourced, the sponsor is still the responsible party and still needs to oversee the quality of the work done by the CRO.

Benefits & Risks in Using a CRO

Potential benefits of outsourcing to CROs include:

  • Reduction of time and resources needed to develop new product
  • Lower initial investment and on-going costs in hiring personnel, equipment, and facilities needed.
  • Expand greater access to expertise
  • Get access to standardized process of clinical trial conduct

Potential risks of outsourcing to CROs include:

  • Reduced control in direct management of clinical trial conduct
  • Potential cost overruns due to unexpected delays
  • Consistency from project to project may vary depending on personnel turnover at CROs

Growing Trend in Outsourcing Work to CROs

Some of the largest CROs include Quintiles, Parexel, Covance, Pharmaceutical Product Development (PPD), Icon Clinical, INC Research, inVentiv Health Clinical, Charles River Laboratories (CRL), etc.

As clinical trial are conducted more and more globally, the industry trend is heading toward the outsourcing model where sponsors are outsourcing more and more of the work out to CROs. Large CROs with global reach are dominating the market with full service offering. Yet there is room to grow for smaller CROs in different regions of the world. The trend for outsourcing of clinical trial related work remains strong for the foreseeable future. Learn more about what it’s like working as a CRA at a CRO.

Author

Post author

Ernie Sakchalathorn

Polachai Ernie Sakchalathorn is the founder of ClinicalResearchAssociateCRA.com and has been in clinical research since 2007. While he is no longer affiliated with the website or benefits financially from site operations, he still remains a professional in the clinical research space and currently serves as a Clinical Affairs Manager at a medical device company.

Leave a Reply

Your email address will not be published. Required fields are marked *