The innovative RWD eConsent solution is ideal for enhancing clinical trials with Real-World Data (RWD), achieving privacy compliance and improving patients’ engagement.
Switzerland, Morges, 12 June 2019 – Pryv, the leading Swiss provider of privacy and personal data management software, and BGO Software, a Bulgaria-based leading software services and product development company, have announced the launch of an innovative eCRF solution to manage Real-World Data (RWD) and informed electronic consent (eConsent).
Designed to meet the requirements of GDPR and HIPAA regulations, the eCRF solution is based on Pryv.io middleware and BGO Software’s Metaforms software. Among the key functionalities of the solution is its ability to dynamically capture and store patients’ informed eConsent. To ensure trust and compliance, a full audit trail documenting interaction with the data is embedded in the solution.
The web-based form-building software allows researchers and clinicians to capture patients’ RWD and pave the way to useable insights . This data includes information from complex forms, questionnaires, voice input, wearable devices, mobile health (mHealth) apps, electronic patient-reported outcomes (ePRO), environment and more.
RWD is considered to be a major source of valuable information from patients in real-world conditions. Capturing RWD improves personalized patient care and enables more efficient scientific and clinical research. Additionally, this data makes it possible to monitor a patient’s safety and evaluate risk, 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.”
Though the software architecture of an mHealth application is important to ensuring the successful implementation and usage of the solution, this is only one part. A user-friendly design is more than just aesthetics. It 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 Pryv/BGO eCRF RWD solution can be accessed anywhere and can be customized to fit the needs and processes of any business or organization. Its functionalities benefit multicenter clinical trials. An API for third-party integrations has been made available to optimize data collection and real-time sharing. The solution is easily adopted and can be quickly launched – a transition to a paperless process is possible within a few weeks and the solution can be deployed on site or over the cloud.
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.
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.