Monday, January 8, 2024

What is CRO

What is Contract (Clinical) Research Organization?

  • A Clinical Research Organization (CRO) is contracted by a pharma, biotech or related entity to manage and lead their clinical trials.
  • Organizations contract with CRO Companies so they can acquire specific expertise without having to invest in their own staff. Reducing the time it takes to conduct a trial compared to conducting the trial in-house results in substantial cost savings. It also eliminates the need for infrastructure and office space to run the trials themselves. 
  • Some CRO Companies manage most aspects of a clinical trial, right from the site selection and patient enrolment to the final regulatory approval.
  • Clinical Research Organizations can be involved in a range of services from project management, bioanalytical services, database design, data entry and validation, data management, disease coding, reporting, statistical analysis, validation programming, safety & efficacy summaries and the final study report.
  • The main areas which CRO Companies are involved in include infectious disease, oncology, infectious disease, the central nervous system, cardiovascular disease and metabolic disorders.
  • Utilizing the services of CRO Companies is also a cost-effective way for companies to develop medications for rare conditions or conditions which only a few people suffer from.
  • Although the sponsoring company transfers the trial functions to a CRO Clinical Research Company, the sponsor is responsible for the trial’s integrity and needs to ensure results are factual and scientifically backed.

                                                                                Next: Clinical Trial Lifecycle

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