Contract research organization Definition, regulatory aspects
A Contract Research Organization (CRO) is an organization that provides specialized services to the pharmaceutical, biotechnology, and medical device industries to assist in the process of research and development of new drugs, biologics, and medical devices. CRO`s provide a variety of services, including clinical trials, regulatory affairs, data management, and laboratory services.

CROs are regulated by the US Food and Drug Administration (FDA) and other regulatory bodies around the world. The FDA requires CROs to comply with Good Clinical Practice (GCP) guidelines, which are designed to ensure the safety and efficacy of clinical trials. Additionally, CROs must adhere to the International Conference on Harmonisation (ICH) guidelines, which are designed to ensure the quality and consistency of clinical trials conducted in different countries.
What does a contract research Organisation do?
What does a contract research Organisation do?
A Contract Research Organization (CRO) is a company that provides outsourced services to the pharmaceutical, biotechnology, and medical device industries. These services include clinical trials, laboratory testing, data management, regulatory affairs, and other research and development activities. CROs are typically hired by pharmaceutical companies to help them develop new drugs and medical devices. They provide expertise and resources that the pharmaceutical company may not have in-house.
What do CRO do in clinical trials?
CRO stands for Clinical Research Organization. They are responsible for managing and conducting clinical trials on behalf of pharmaceutical companies, medical device companies, and other organizations. They are responsible for the design, implementation, and management of clinical trials, including the recruitment of participants, data collection, and analysis. They also provide regulatory and quality assurance services to ensure that the clinical trial is conducted in accordance with applicable regulations and standards.
How do you evaluate a Clinical Research Organization?
1. Experience: Evaluate the Clinical Research Organization's experience in conducting clinical trials. Look for organizations that have a proven track record of successful clinical trials.
2. Quality: Evaluate the Clinical Research Organization's quality assurance and quality control processes. Ensure that the organization has a comprehensive quality management system in place.
3. Regulatory Compliance: Evaluate the Clinical Research Organization's compliance with applicable regulations and guidelines. Ensure that the organization is compliant with all applicable laws and regulations.
4. Cost: Evaluate the Clinical Research Organization's cost structure. Ensure that the organization is providing competitive pricing for its services.
5. Resources: Evaluate the Clinical Research Organization's resources. Ensure that the organization has the necessary personnel, equipment, and technology to conduct successful clinical trials.
Contract research organization Market size and growth
The global contract research organization (CRO) market size was valued at USD 39.2 billion in 2019 and is expected to grow at a compound annual growth rate (CAGR) of 8.2% from 2020 to 2027. The growth of the market is attributed to the increasing demand for cost-effective drug development services, the growing number of clinical trials, and the increasing number of collaborations between pharmaceutical companies and CROs. Additionally, the increasing number of government initiatives to support the development of new drugs and the increasing number of mergers and acquisitions are expected to drive the growth of the market.
Top CROs by annual revenue
1. Vial - $7.2 billion
2. Parexel International Corporation (PRXL) - $2.2 billion
3. ICON plc (ICLR) - $1.9 billion
4. Covance Inc. (CVD) - $1.7 billion
5. PRA Health Sciences (PRAH) - $1.3 billion
6. INC Research (INCR) - $1.2 billion
7. Chiltern International (CHL) - $0.9 billion
8. Syneos Health (SYNH) - $0.8 billion
9. PPD Inc. (PPD) - $0.7 billion
10. Medpace Holdings (MEDP) - $0.6 billion
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