Secure and compliant electronic consenting application ensures ease of use and comprehension for patients, simplifies process oversite for sites, and ensures fast approvals during virtual and hybrid trials.
ROCHESTER, NY – October 13, 2020 – Bio-Optronics, Inc., the makers of the CCTrialSuite that includes the CTMS most widely used by sites in the world, announces significant telehealth enhancements to the recently launched CCeConsent – now the industry’s most secure remote eSignature solution for electronic informed consent that ensures regulatory compliance, empowers patient understanding and eliminates unnecessary study delays for decentralized, virtual and hybrid trials.
By simplifying the building of engaging multi-media content, CCeConsent helps ensure patient understanding and increase retention. The ability to capture 21 CFR Part 11 compliant eSignatures from any device is key to providing a secure consent solution that is easy for patients to use. This feature makes CCeConsent the first truly secure BYOD (Bring Your Own Device) telehealth approach to consenting during decentralized and virtual trials.
“CCeConsent provides a more consistent and compliant process than competing systems that benefits sites and sponsors alike, not only reducing costs by eliminating paper and the need for in-person consenting, but also increasing patient access by providing the flexibility to be performed in-person or completely remote with optional parallel video interaction.”, said Cooper Vanlare, Commercialization Manager
CCeConsent is complemented in the CCTrialSuite by the CC CTMS integrated CCVideo, providing the perfect mix of tools for increasing study enrollments remotely. In this way, users can see and interact with patients, caregivers and family members while tracking the consenting process and level of comprehension. CCeConsent centrally stores essential form completions and secure eSignatures during a remote workflow. It also reduces staff burdens by providing modular templates for quickly customizing consenting per subject with minimal effort, in addition to providing strict version control over multiple consent versions. With basic texting capability embedded in CCeConsent, sending messages is both faster and easier.
Users will also benefit from the efficient training and deployment of CCeConsent. Known for stellar customer support, at no additional cost, Bio-Optronics even helps new users setup the first few interactive consent flows to submit for IRB approval.
According to Max Elbaz, Chief Commercial Officer, “Bio-Optronics is committed to providing secure and compliant remote workflow technologies for hybrid and virtual trials, making sure tools such as CCeConsent are continually enhanced to deliver all capabilities needed to keep trials operating safely and efficiently. In collaboration with our valued customers, CCeConsent will continue to evolve to meet ease of use, safety, regulatory, efficiency and security needs of a quickly changing industry.”
CCeConsent give organizations the ability to deliver sponsor-required results faster, with higher quality, less effort, increased safety, and reduced expenditure, while ensuring virtual and hybrid studies operate as efficiently as possible. CCeConsent is also designed to eliminate patient barriers with easy remote access, interactive content, 21 CFR Part 11 compliant security, and support for multiple languages. This results in the easy to use and highly secure remote consenting capabilities required for our new clinical trial landscape.
Bio-Optronics is a leading software and services company dedicated to providing user-focused applications for healthcare organizations that positively impact operational performance and final results. With applications focused on clinical research, automated resource utilization and patient safety, Bio-Optronics solutions are used by thousands of healthcare organizations worldwide to simplify complex clinical processes, enhance financial performance, ensure regulatory compliance, increase patient safety, boost efficiency, and ensure the overall quality of results.