OpenClinica is a software company based in the United States, founded in 2004, that specializes in electronic data capture (EDC) systems primarily for clinical trials. With a workforce of 11 to 50 employees, the company offers a commercial off-the-shelf (COTS) system designed to facilitate data management in healthcare settings. OpenClinica's published documents include guidelines and standard operating procedures (SOPs) that outline essential data management practices for users of EDC systems. These SOPs cover various aspects such as data privacy, document management, and quality control procedures, ensuring compliance with regulatory requirements. The company emphasizes the importance of auditing software vendors and maintaining proper documentation throughout the clinical trial process. OpenClinica's focus on providing structured data management solutions reflects its commitment to supporting healthcare organizations in conducting efficient and compliant clinical research.