OpenClinica

OpenClinica's Clinical Research Software Solutions

OpenClinica offers a comprehensive suite of clinical research software solutions that cater to the diverse needs of the clinical trial industry. Their offerings include electronic data capture (EDC), electronic patient-reported outcomes (ePRO), eSource EHR EDC integration, randomization, and reporting. These tools are designed to enhance the efficiency and accuracy of clinical trials, supporting adaptive platform trials, master protocol trials, umbrella trials, observational research, interventional trials, registries, and real-world evidence research. OpenClinica's solutions have been utilized in over 15,000 studies involving more than three million patients worldwide, underscoring their scalability and reliability.

OpenClinica's Professional Services

OpenClinica provides a range of professional services to support the implementation and optimization of their software solutions. These services include study configuration, migration, integration, and training, ensuring that clients can seamlessly adopt and utilize the platform. The company’s expertise in these areas helps organizations streamline their clinical trial processes, reduce errors, and achieve regulatory compliance. OpenClinica's professional services are tailored to meet the specific needs of life science companies, academic institutions, and government entities, making it a trusted partner in the clinical research community.

OpenClinica's Cloud-Based Platform

OpenClinica offers a secure, cloud-based platform that automates source data acquisition and workflows, bridging the gap between healthcare and research. The platform supports diverse study types, including clinical trials, real-world evidence (RWE), and digital health. With features such as an intuitive electronic case report form (eCRF) design interface, patient-centric eConsent solutions, and real-time data visualization through Insight, OpenClinica’s platform is designed to enhance data integrity and streamline study management. The platform's secure infrastructure is certified with SOC and ISO27001, ensuring data protection and compliance with regulatory requirements like 21 CFR Part 11, GDPR, and HIPAA.

OpenClinica's ePRO and eConsent Solutions

OpenClinica provides a fully integrated electronic patient-reported outcomes (ePRO) solution that works on any device without the need for an app download. This flexibility ensures high patient engagement and data accuracy. Additionally, their patient-centric eConsent solution includes multimedia support and automated workflows, making the consent process more comprehensive and user-friendly. These solutions not only enhance patient experience but also improve the quality and reliability of the collected data, which is crucial for the success of clinical trials.

OpenClinica's Regulatory Compliance and Security

OpenClinica is committed to maintaining the highest standards of regulatory compliance and data security. Their platform supports compliance with key regulatory requirements such as 21 CFR Part 11, GDPR, and HIPAA. Additionally, OpenClinica provides a secure cloud infrastructure with SOC and ISO27001 certification, ensuring that all clinical trial data is protected against unauthorized access and breaches. This robust compliance framework not only safeguards sensitive information but also enhances the credibility and reliability of the clinical research conducted using their platform.