• Spreading Adoption of Telehealth Solutions
• Fostering eConsent Acceptance
• Leveraging Real World Evidence Data
• Reporting Patient Outcomes

Swiss-made Pryv.io is a ready-to-use personal data lifecycle management software, specifically engineered to empower CRO and Pharma organizations to design and run decentralized, remote and direct-to-patient clinical trials.

• Trials are executed through tele-healthcare, i.e. conducted remotely with participants staying at home.
• Patients can give their consent remotely (eConsent).
• Physician visits can be done remotely (telemedicine).
• Data can be captured remotely via digital biomarkers (medical devices, wearables, apps).
• Real-World Data can be captured (geolocation, environmental exposure such as temperature, sun, humidity, and allergens).
• Lifestyle data can be integrated (nutrition, sleep, stress…).
• Multi-centric clinical trials are conducted where data is stored in different locations.
• Full compliance is respected in terms of data lifecycle management, patient rights, user access control and audit.

“Our platform will not only capture patient data but will also give participants a view on their own trial dataset, sending a strong message of transparency and inclusivity, which can truly engage them.”

Pierre-Mikael Legris, CEO Pryv SA

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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.

Contact us to book eCRF / RWD platform demo 

About Pryv

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.

About BGO

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.

The post Pryv and BGO launch privacy-centric eCRF solution allowing to capture patient’s RWD and Informed Consent appeared first on Pryv.

The collaboration includes the development of an innovative clinical data management solution providing a comprehensive picture of each patient’s journey – one which combines patient reported outcome (PRO) data with clinical records collected by healthcare professionals. The platform is designed to meet the unique needs of the investigational research as well as the post approval market, including phase IV studies, registries and online medical communities.

“Patient relevant outcome measures are a proven necessity to assess the efficiency, effectiveness and personalization of clinical trials” said Samir Mechati, CEO at RodanoTech “It supplements existing clinical data, increases treatment adherence and provides important insight about how patients are doing between medical visits”.

The patient data set is expanding from the high-quality information collected in the clinical protocol to the more private data collated from wearables, mobile apps and in-home clinical devices. By streamlining the collection and integration of this dataset, the joint Pryv/RodanoTech solution ensures a real-time connection with the patient health – capturing insightful data measured and influenced outside the four walls of the clinical setting.

“Real time, real world data that can be captured in patients’ daily lives is a powerful tool to optimise clinical research” said Pierre-Mikael Legris CEO at Pryv “Our platform will not only capture patient data but will also give participants a view on their own trial dataset, sending a strong message of transparency and inclusivity which can turn them truly engaged”.

Patient consent is a critical process that has historically been highly inefficient and prone to error. The joint Pryv/RodanoTech platform optimises that additional level of security between participants and clinical trial sites. Its greatest value comes from its dynamic, fine-grained consent and re-consent capability which gives patients the trust, transparency and control they require from clinical trials. The platform logs all authorizations, including the ‘contract’ between the patient and the investigator, for compliance oversight as mandated by GCP guidelines and privacy regulations.

RodanoTech and Pryv offer tailored solutions to conduct projects of any size, from small Phase I studies to large scale trials involving sophisticated designs and long-term follow-up across clinical settings and geographies. Our Academic offer begins with a “get started” costing for proof of principles and goes to a premium packaged solution for large scale clinical trials.

Contact us to discover the power of a tailor-made platform combining clinical and patient health data and supported by leading experts with extensive experience in clinical development.

About Pryv
Pryv helps organisations manage personal data from creation, to 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.

About RodanoTech
RodanoTech is specialised in clinical data management services and electronic data capture solutions for industry and academic projects. The RODANO platform is the underlying proprietary technology that powers all RodanoTech solutions. RODANO is based on the most recent technical standards to streamline all aspects of the study conduct and complies with the latest recommendations regarding the use of computerized systems in clinical investigations (21 CFR Part 11). The platform can scale and adjust to accommodate clinical trial complexities through systematic automation of repeatable processes while providing appropriate hooks to new data collection methods.

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