Clinical trial management software firm Bio-Optronics has released a number of telehealth enhancements to its CCeConsent eSignature solution for electronic informed consent. According to the company, the technology helps ensure regulatory compliance, empower patient understanding and reduces delays for decentralized and hybrid trials.
The solution is designed to simplify the process of building multimedia content, in order to increase patient understanding and retention of information. The ability to capture 21 CFR Part 11 compliant eSignatures from any device is intended to provide users with a secure consent solution easy for patients to interact with.
Cooper Vanlare, commercialization manager for Bio-Optronics, said the CCeConsent technology offers users with a range of benefits designed to increase efficiency, cost-effectiveness and patient-centricity.
“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,” Vanlare said.
Other features designed to work with the CCeConsent feature of the CCTrialSuite CTMS is CCVideo, which delivers a combination of tools intended to help increase remote study enrollments. It enables users to see and interact with patients, caregivers and family members while tracking the consenting process and level of comprehension.
CCeConsent centrally stores completed forms and secure eSignatures during a remote workflow. It also reportedly reduces staff burden by providing modular templates that enable quick customizing of consenting per subject with minimal effort, as well as allowing version control over multiple consent versions; additionally, embedded basic texting capability enables fast, simple sending of messages.
Max Elbaz, chief commercial officer, said, “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 reportedly allows users to deliver sponsor-required results faster, with high quality, reduced effort, increased safety, and reduced expenditure, while ensuring efficient operation of decentralized and hybrid studies. The solution also is engineered to reduce patient barriers with easy remote access, interactive content, 21 CFR Part 11 compliant security, and support for multiple languages.
Bio-Optronics is an associate sponsor of CRAACO 2020, a virtual online event (scheduled November 4-6) focused on sharing trends discussing solutions around clinical trial as a care option. Visit bit.ly/3kBUce5 for more information.