“An automated process of document versioning and centralized record storage also enables us to ensure that our consenting process is accurate and compliant with both the study protocol and Institutional Review Board guidelines.” Mike SchembriClinical Research ProgrammerUCSF
SAN FRANCISCO (PRWEB) November 01, 2018
Medrio, the leading provider of eClinical technology for early-phase pharma, medical device, and diagnostics clinical trials, has released Medrio eConsent, a tablet-based electronic informed consent application for clinical trial patients. The FDA-compliant product will empower organizations conducting clinical trials to accelerate and simplify their processes, increase compliance, and improve patient retention rates. Introductory pricing for Medrio eConsent is available for Phase I clinical trials through the end of 2018.
Medrio eConsent is the latest innovation from a company known for being the first cloud-based electronic data capture provider, an eSource pioneer, and a user-friendly alternative to the more complex and technically demanding EDC solutions used in large Phase III studies. The product uses the cloud to enable sponsors and CROs to instantly propagate consent forms and deploy changes across all clinical trial sites. By replacing paper consent documents, which require physical storage and carry the risk of loss or damage, with electronic forms, Medrio eConsent will enable users to store data electronically, simplifying reporting and audits and further strengthening regulatory compliance.
In addition to delivering user benefits to sites and sponsors, Medrio eConsent promises to be a valuable patient engagement tool at a time when the clinical research industry is increasingly incorporating patient priorities and input into its processes. The product will leverage graphics, videos, quiz modules, and FAQ documents to increase patient comprehension during informed consent, reducing patient attrition and saving recruitment and study delay costs. It will also protect patients’ personally identifiable information (PII) through strong encryption and data protection measures. By facilitating comprehension and convenience for patients, organizations will be well positioned to maintain healthy patient retention numbers.
The release comes on the heels of two rounds of beta testing in which Medrio customers interacted with Medrio eConsent in test environments. “Patients who participate in clinical trials fill out multiple forms, many of which have significant technical and legal language, so it’s important for us to find a more engaging and informative experience for the participants,” said Mike Schembri, Clinical Research Programmer at the University of California, San Francisco, who participated in beta testing of the product. “An automated process of document versioning and centralized record storage also enables us to ensure that our consenting process is accurate and compliant with both the study protocol and Institutional Review Board guidelines.”
Medrio eConsent arrives amid growing demand for improved informed consent processes in clinical trials. In addition to the industry’s increased focus on patient engagement, the FDA has released substantial guidance for the use of electronic informed consent in recent years, and this year’s General Data Protection Regulation (GDPR) requires the industry provide a consent process that is more thorough and comprehensible to the layperson. “Medrio has been accelerating clinical trials and helping to improve the patient experience since 2005, and Medrio eConsent is a major step forward in those efforts,” commented Mike Novotny, founder and CEO of Medrio. “After seeing its positive impact in beta, we’re excited to release it to the global market.”
Organizations interested in accelerating and simplifying their consent processes can learn more about Medrio eConsent at Medrio’s website.
Medrio is the leading provider of eClinical technology for early-phase pharma, device, and diagnostics clinical trials. Founded in 2005, the company's cloud-based EDC, eSource, eConsent, and ePRO solutions deliver fast, flexible, and easy-to-use tools for the collection and management of clinical data and patient reported outcome responses. Study sponsors and contract research organizations have used Medrio extensively in clinical trials across a wide array of therapeutic areas, with notable success in oncology, infectious disease, and more. Medrio has extensive experience in all study phases and leads the market in early-phase trials. The company serves over 500 customers globally, with headquarters in San Francisco and offices in numerous domestic and international locations. For more information, please visit http://www.medrio.com.
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The information stated above was prepared by Medrio and reflects solely the opinion of the corporation. Nothing in this statement shall be construed to imply any support or endorsement of Medrio, or any of its products, by The Regents of the University of California, its officers, agents and employees.