Preclinical contract research organizations play a key role in the testing of new medications and medical devices. So much behind-the-scenes work goes into successfully starting a clinical trial, and most of that work receives little to no publicity. Let’s explore the ways that a CRO helps a sponsor start a trial.
Study Design and Planning
One of the key ways that CROs help with trials is through the planning and design of the study. A preclinical contract research organization typically helps sponsors develop robust protocols for it and also ensures those protocols meet any governmental requirements as well as scientific objectives.
Regulatory Compliance
CROs are crucial in ensuring sponsors comply with all of the regulatory requirements involved with the trial. These regulations can include the following:
FDA Good Clinical Practice (GCP)
Clinical Trials Registration
Common Rule
Results Submission
These regulations require sponsors to obtain informed consent from human trial subjects, disclose financial details to all involved parties, and allow the oversight of an institutional review board. They also require trial holders to treat subjects ethically and register their studies with the federal government if required. A CRO ensures the sponsor holding the trial abides by all of the applicable regulations.
Animal Model Development
A CRO will likewise identify and provide the trial sponsor with animals suited for the trial’s intended purpose. This important task ensures the trial can test the safety and effectiveness of medications in the process of development and the invention of new medical devices.
Toxicology Testing
Preclinical research organizations additionally perform assessments on new medications being tested in the trial. It specifically tests the medications’ toxicology and determines what potential side effects and risks come with them. The organization then ensures the sponsor reports these side effects and risks to the federal government and other applicable agencies.
Pharmacokinetics and Pharmacodynamics Studies
Trial holders rely on CROs to perform both pharmacokinetics and pharmacodynamics studies on new medications under development. These studies identify how the human body absorbs and excretes these medicines. They also pinpoint how the medications are distributed and metabolized in the human body and what, if any, biological effects they have.
Manufacturing and Formulation Support
Once the trial nears its end, the CRO assists the sponsor in manufacturing the developed medical device or medication. This process also involves optimizing the formulations for the medication and the manufacturing of the medical device for preclinical testing. The company sponsoring the trial will have a better idea of how and to whom to market the product.
Data Management and Reporting
CROs collect, analyze, and report findings in the study to all of the involved regulatory agencies. They present this information in formats that are suitable for agencies, like the following:
The U.S. Food and Drug Administration (FDA)
European Medicines Agency
National Institutes of Health (NIH)
Health Canada
Other agencies can include the Medicines and Healthcare Regulatory Agency in the U.K. and the Pharmaceuticals and Medical Devices Agency in Japan.
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These tasks are some that CROs assist with during trials. They ensure sponsors holding the trials comply with all of the regulations and report their findings to the applicable agencies.
