A contract research organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis.
How do the life-changing drugs reach the patients?
The drug is discovered; a drug is developed and undergoes preclinical testing and different phases of clinical trials. A huge investment is involved in this process and many clinical trial experts are putting their best efforts and knowledge to get the drug to reach the patients. CRO plays a very important role in these stages.
A Sponsor must have a partnership with CRO that is adaptable and overviews the data and information available. And trust is a vital essence required in this partnership. In partnerships, changes do happen and this is evitable and this is the part and parcel of the process. CROs need to be treated like partners rather than vendors.
Contract research organizations (CROs), were involved in only certain aspects of the conduct of the clinical trials in the beginning. Over a period of time, CROs emerged as companies that provided a wide range of services for clinical trials from investigator selection to biostatistics. This resulted in CROs assuming more of the regulatory and ethical risks and responsibilities involved in the conduct of the clinical trials. CROs, unlike sponsors, are not interested in the outcome of study but are subject to the regulations by the government.
CROs are always judged by the quality of facilities they provide and professional working relationships with investigators and institutions, and the validity of the data. CROs are subject to comprehensive audits by sponsoring companies, and other regulatory authorities. CROs are being tasked with the strict vigilance of all stages of the clinical trial process to ensure that the laws, regulations, and industry standards designed for the protection of human subjects and data integrity are maintained.
CROs and mergers and acquisitions of CROs
In 2017, Quintiles and IMS together became IQVIA, INC and Inventive merged. Some of the CROs are:
• Parexel International,
• Icon Plc,
• Syneos Health,
• Covance Inc.,
• GVK Bio,
• Medpace Holdings, Inc.
In CRO, the main role is played by the CRA in conducting the clinical trial. They act as an interface with the site. CRAs act as the main line of communication between a Sponsor and an investigator or a trial site.
Their major responsibilities include:
• Monitoring the progress of the study at the trial site
• Ensuring that all the individuals involved in the trial are performing their functions in accordance with the protocol, in compliance with GCP and other regulatory requirements
• Verifying that the investigator has adequate qualifications and resources and remain adequate throughout the trial period, those facilities, including laboratories, equipment, and staff, is adequate to safely and properly conduct the trial and remain adequate throughout the trial period.
There are different types of CRAs. Some are called “in-house CRA” and some are called “regional CRA” or “Monitors”. In-house CRA is located in house and they perform the duties from the sponsor location. They seldom visit the trial sites. Regional CRAs are called monitors and have to visit the site very often.
Project Managers are responsible for the overall activities of the trial and manage the entire study from the start-up to the close-out. CTAs (Clinical Trial Associate) provide the support to the Project Managers and CRAs on various study related duties.