A contract research organization range of clinical research services to (CRO) provides research services to pharmaceutical, biotechnology, and medical device companies. Services can range from drug discovery to commercialization, pharmacovigilance to post-approval services. Within clinical trials, a sponsor (the organization seeking to investigate the safety and efficacy of a new treatment) hires a CRO on a contract, project-by-project basis. CROs provide the expert guidance, advice, and execution experience required to complete clinical trials safely and efficiently — without the sponsor having to hire such staff on a full-time basis.

How do Clinical Trials Work?

Once researchers have done initial testing on a promising treatment in a lab, they must initiate a clinical trial to prove its safety and efficacy before being allowed to market it to the public. A CRO will conduct the trial in successive phases (Phase I, Phase II, and Phase III). The first step is to enroll clinical trial participants — who must meet certain criteria depending on the intended patient profile of the specific trial — and who may be compensated for their time. As each phase of the trial progress, more is learned about the effectiveness, risks, and side effects of a treatment.

Contract Research Organization Roles and Responsibilities

A CRO is responsible for planning, setup, and day-to-day execution and management of its contracted clinical trial. Handling and supervising the technical side — data collection and medical testing — comprise a significant portion of its tasks. It is important to note that clinical compliance with regulatory agency guidelines is crucial, and adhering to Good Clinical Practice (GCP) standards is part of the CRO’s role as it acts as the trial’s central hub, connecting the sponsor with other stakeholders such as regulatory agencies, ethics committees, vendors, hospitals, etc.

What is a CRO in Clinical Trials?

In clinical trials, a CRO is the entity that plans, develops, and coordinates the clinical trial protocol. Then, it executes that protocol in accordance with regulatory agency rules and GCP standards. A sponsor — who might have many potential treatments they wish to have tested via clinical trial — engages a CRO to take care of the time-consuming and resource-intensive work required of a clinical trial. The sponsor is able to leverage the expertise of the CRO, which due to the CRO’s repeated execution of trial after trial, comes to be able to anticipate potential delays and pitfalls, avoiding them ahead of time.

What Does a Contract Research Organization Do?

CROs are able to provide a wide range of clinical research services to medical sponsors, including, but not limited to:

• Project and Data Management
• Clinical Study Oversight and Execution
• Research Education and Compliance
• Medicine and Disease Coding
• Validation Programming
• Product Development Planning and Commercialization
• Safety and Efficacy Reporting
• Quality Analysis
• Biostatistical Review
• Statistical Analysis
• Medical Writing

Types of Contract Research Organizations

Different CROs can offer varying services, but they are most commonly grouped by where their contribution falls on the sponsor’s research timeline, along with the CRO’s primary function:

• Discovery
• Preclinical
• Clinical
• Laboratory Services

About Synteract

Synteract®, a Syneos Health® company, is a leading full-service CRO focused on the emerging biopharma segment. The Company's multidisciplinary teams support biotech and pharmaceutical companies across all phases of drug development, providing deep expertise in oncology, dermatology, general medicine, infectious disease and vaccines, neuroscience, pediatrics, and rare and orphan diseases. Synteract has conducted nearly 4,000 studies on six continents in over 62 countries. Contact us today to learn how our team of experts can help bring your next clinical trial to life.