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It is essential to be able to rely on a CRO as a partner to trust the study's management, and in this case, the CRO serves as a conduit between the investor, the one who contracts the services, and the rest of the clinical trial actors.
FREMONT, CA: A CRO is a Contract Research Organization. It is a category of an organization that primarily provides manufacturers of pharmaceutical, biotechnology, and medical equipment with its clinical trial management services. When several actors intervene, a clinical trial's management is more complex than it would seem (manufacturers, sponsors, ethical committees, competent authorities, centers, foundations, researchers, legal departments, participants).
Besides, studies must be performed in compliance with the principles of Good Clinical Practice and the Guides for Harmonization (GCP-ICH Guidelines) to ensure the research's consistency. It is essential to be able to rely on a CRO as a partner to trust the study's management, and in this case, the CRO serves as a conduit between the investor, the one who contracts the services, and the rest of the clinical trial actors.
Services Offered by a CRO
Historically, CROs have been in charge of implementing and monitoring clinical trials. Still, more and more companies offering all the services associated with the conduct of a clinical trial are considered full CROs. The services that a CRO offers may be divided according to the phase of the study:
• The start-up includes the advancement and revision of trial protocols, the adaptation of the required documentation to the applicable legislation, the procuring of the necessary approvals from the clinical research ethics committees and regulatory authorities, the design and preparedness of case report forms, the determination of the sample, the selection of the best scientists and the research contracts.
• Once approval has been obtained and the trial has started, the CRO provides its monitoring services, which consist of monitoring compliance with the protocol and the protocols developed to produce the analysis. In the same way, pharmacovigilance services include detection and action in the event of any adverse event occurring.
• The last steps to ensure any clinical trial success are record management, monitoring, and record tracking and storage.
• Research is carried out during the study in compliance with Good Clinical Practices (GCPs) to ensure the research's quality.