Glossary Term
Contract Research Organization (CRO)
Definition
A Contract (or Clinical) Research Organization (CRO) is a third-party entity that provides outsourced clinical research services to sponsors, such as medical device manufacturers, pharmaceutical companies, or biotechnology firms. CROs manage various aspects of clinical trials, including study design, regulatory compliance, data collection, and analysis, ensuring trials are conducted efficiently and in accordance with applicable standards.
Relevance to the MedTech Industry
CROs play a crucial role in streamlining the clinical trial process by offering specialized expertise, infrastructure, and resources. They enable MedTech companies to focus on innovation while ensuring that clinical trials meet regulatory requirements, generate high-quality data, and are completed on time and within budget.
Additional Information & Related Terms
Good Clinical Practice (GCP) Standards that CROs adhere to for ensuring ethical and scientific quality in trials.
Clinical Investigation Plan (CIP) Often developed and managed with input from a CRO.
Post-Market Clinical Follow-Up (PMCF) A phase of clinical evaluation commonly managed by CROs.
Regulatory Submissions CROs provide data and documentation to support device approvals.