OpenClinica
OpenClinica offers a comprehensive suite of clinical research software solutions, supporting a wide range of clinical trials and providing services such as study configuration, migration, integration, and training. Trusted by life science companies, academic institutions, and government entities, it has been used in over 15,000 studies involving more than three million patients worldwide.
Clinical Research Software Solutions
OpenClinica offers a comprehensive suite of clinical research software solutions, including electronic data capture (EDC), electronic patient-reported outcomes (ePRO), eSource EHR EDC integration, randomization, and reporting. These solutions aim to simplify and automate data acquisition and workflows for clinical trials. They support a wide range of clinical study types, enhancing efficiency and accuracy in data handling.
Services Offered by OpenClinica
OpenClinica provides various services to support clinical research, including study configuration, migration, integration, and training. These professional services are designed to assist researchers in setting up, transitioning, and managing their studies effectively. The company also offers a cloud-based platform that ensures secure data handling and compliance with regulatory standards such as 21 CFR Part 11, GDPR, and HIPAA.
Types of Studies Supported
OpenClinica supports a wide range of study types including adaptive platform trials, master protocol trials, umbrella trials, observational research, interventional trials, registries, and real-world evidence research. Its platform is also tailored to support medical device clinical trials, providing the necessary tools and features for managing these specific kinds of studies.
Key Features and Integrations
OpenClinica offers several key features such as a patient-centric eConsent solution with multimedia support and automated workflows, real-time data visualization through its Insight reporting and analytics solution, and integration with electronic health records (EHR) for automated data capture. The platform also provides a flexible electronic case report form (eCRF) design interface and a fully integrated ePRO solution compatible with any device.
Compliance and Certifications
OpenClinica is committed to maintaining high standards of data security and regulatory compliance. The platform supports compliance with 21 CFR Part 11, GDPR, and HIPAA requirements. It also operates on a secure cloud infrastructure with SOC and ISO27001 certification, ensuring the protection and integrity of clinical research data.