The innovative RWD eConsent solution is ideal for enhancing clinical trials with Real-World Data (RWD), achieving privacy compliance and improving patients’ engagement.
BGO Software, the Bulgarian leading software services provider and product development company, together with Pryv, a Swiss leading privacy and personal data management software provider, launched an innovative eCRF solution for managing Real-World Data (RWD) and informed electronic consent (eConsent).
The eCRF solution is based on BGO Software’s Metaforms Data Collection Platform and Pryv.io middleware, and meets all requirements of GDPR and HIPAA regulations. The ability to dynamically capture and store patients’ informed eConsent is one of the key functionalities the solution provides. Additionally, the solution is provided with embedded full audit trail documenting interaction with the data for ensuring trust and compliance.
The web-based form-building software empowers researchers and clinicians to capture patients’ RWD. This data includes information from complex forms, questionnaires, voice input, wearable devices, mobile health (mHealth) apps, electronic patient-reported outcomes (ePRO), environment and more.
Real-World Data is a main source of valuable patients’ information in real-world conditions. Capturing RWD is crucial for improving personalized patient care. Moreover, RWD capturing enables more efficient scientific and clinical research. This data allows monitoring of a patient’s safety and evaluating risk. In addition, it makes it possible to demonstrate efficacy and effectiveness, gain market access and address the public’s growing interest in an efficient and sustainable healthcare system.
“Real-World Data is undoubtedly a valuable asset. However, creating and integrating dynamic forms and complying with regulations can be a very complex task and requires specific knowledge,” said Ivailo Ivanov, CTO of BGO Software. “Collaborating with Pryv adds an additional layer to the management of clinical data in our product Metaforms and ensures the patient’s data remains private. This is vital to ensuring they feel confident in sharing their data and giving us access to RWD.”
The software architecture of an mHealth application is important to the successful implementation and usage of the solution, still this is only a part of it. A user-friendly design plays a crucial role in the patient’s engagement, the operational efficiency, and the overall management of clinical data.
“A regulatory-compliant eCRF solution is one of the most common requests we receive from customers,” said Pierre-Mikael Legris, CEO of Pryv. “A user-friendly design is the key to collecting enriched RWD. By using BGO’s clinical data management experience and engineering know-how, we have been able to create an easy-to-use, modern and intuitive end-to-end solution that captures RWD and manages dynamic eConsent.”
The eCRF RWD solution is accessible from anywhere and it can be customized to the needs of any business or organization. Its functionalities makes it very beneficial for multicenter clinical trials. The solution is provided with an API for third-party integrations for optimizing data collection and real-time sharing. The BGO/Pryv privacy-centric eCRF solution can be adopted easily and launched quickly – a transition to a paperless workflow is possible within a few weeks. The solution is suitable for deployment on site or in a cloud environment.
BGO designs and develops solutions that help and support a number of governmental institutions, enterprises and IT organizations globally and has considerable expertise, primarily in healthcare, pharmaceutical and the clinical research industry. The company facilitates the work of researchers, clinicians, CROs, biotechnology experts, trial managers, trial investigators, coordinators and other industry administrative professionals. BGO Software is an official Microsoft Gold Partner, Specialized supplier for manufacturing of IT of Hoffmann-La Roche and Genentech, Official Government Supplier for the Health Research Authority of the Department of Health in the United Kingdom & Progress Premier Partner.
Pryv helps organisations manage personal data from creation, use and sharing as well as address the enhanced data subject rights under GDPR such as transparency, portability and right-to-be-forgotten. Packaged for rapid integration, the software solution comes with a turnkey IoT connectivity, secure storage vault, fine-grained consent management and comprehensive auditing capability that radically cut IT development costs and accelerate time-to-benefit while addressing most stringent data protection requirements.