Software Makes It Easy for Patients, Sites and Sponsors to Share Knowledge and Streamline Approvals During Decentralized Trials
PALO ALTO, Calif.–(BUSINESS WIRE)–#biotech—Medable Inc., the leading software provider for decentralized clinical trials, today announced general availability of Medable TeleConsent™, a new product that enables fully remote informed consent and re-consent for clinical trials. Unlike traditional eConsent products that require both patient and investigator to be physically present together in the clinic, Medable TeleConsent allows patients, doctors, nurses, and clinical trial staff all to connect and sign remotely from any location.
Medable TeleConsent solves one of the most complex aspects of clinical trials for sites and sponsors—and transforms the initial experience for patients. By eliminating the need for multiple round-trip visits to clinical sites, TeleConsent dramatically improves patient access to studies, connecting them directly with trial investigators and site teams from their home location. This results in faster enrollment, greater participant diversity and better retention for trial sponsors.
TeleConsent also improves patient knowledge and comprehension by providing medical information in visual and multimedia formats, which patients can review in depth together with family members and caregivers. They can then engage visually with their physician to sign consent forms digitally from the comfort of their home or local clinic.
Medable TeleConsent is especially critical in the COVID-19 environment, where many patients are staying home to avoid social interaction and minimize exposure. Sites and sponsors can now screen, enroll and consent study participants without meeting in person, taking advantage of Medable’s TeleVisit application to conduct personalized interactions that improve patient understanding. Sites and sponsors benefit from streamlined workflows and enhanced data quality and compliance. Sponsors also get increased transparency with real-time reporting and insight into study progress. TeleConsent can also be used for re-consenting patients for any future changes that may happen in a clinical trial.
“Medable TeleConsent is a critical step in the evolution of decentralized research, as consent is the gateway to trial participation,” said Dr. Michelle Longmire, CEO and co-founder of Medable. “This has the potential to enable global patient access and improved knowledge, leading to greater participant diversity, retention, and ultimately research quality and speed. We’re excited to break down these barriers to benefit patients, sites and sponsors alike.”
Medable TeleConsent was designed uniquely with a patient-centric perspective, informed by Medable’s Patient Advisory Council, a nationwide network of advocates who advise Medable and customers on ways to improve patient access, experience, and outcomes.
“As the mom of three sons with rare diseases, we have a lot of experience with travel burden,” said Jennifer McNary, rare disease advocate and chair of Medable’s Patient Advisory Council. “I definitely support reducing the risk to families, especially those with compromised health during this time. Making consent remote also helps those who may not otherwise be able to participate in a trial.”
Medable TeleConsent is designed to be flexible, so the features can adapt to local regulatory, site and patient-preferred workflows. This enhances the experience while ensuring clear and accurate dissemination of critical information. TeleConsent also records digital evidence of comprehension and knowledge transfer, while capturing investigator and patient agreements to proceed. Having access to digital records is valuable for all stakeholders and sets the foundation for ongoing digital engagement between sites and patients.
Dr. Remo Moomiaie-Qajar, president and CEO of Cytonus Therapeutics, agrees with this approach. “At Cytonus, our diverse portfolio includes a COVID-19 therapeutic. One major problem we have had is the constantly changing regulatory requirements in various regions and countries. This has added multiple layers of complexity when it comes to consenting and necessitates re-consenting patients. Given that most therapeutics to treat viruses like COVID-19 are time-sensitive for the health of the patient, without a solution like Medable TeleConsent we would have significant delays enrolling patients that are extremely costly. Medable TeleConsent eases the administrative burden of thousands of hours safely spent remotely consenting for both investigator and patient.”
Available immediately, Medable TeleConsent was designed specifically to power several modalities of decentralized trials—and is the first eConsent application that enables patients, sites and sponsors to all engage remotely via web or mobile device in multiple languages.
Please click here to register for a live webinar October 6 on using TeleConsent to reduce patient burden in decentralized trials.
Medable is on a mission to get effective therapies to patients faster by transforming clinical drug development with disruptive technologies. The company offers a flexible digital platform for decentralized trials, replacing siloed systems with integrated tools, data and interfaces to streamline design, recruitment, retention and data quality. Medable connects patients, sites and clinical trial teams to improve patient access, experience, and outcomes. Medable is a privately held, venture-backed company headquartered in Palo Alto, California. For more information, visit www.medable.com and follow @Medableinc on Twitter.
Lisa Barbadora, Big Valley Marketing for Medable, +1 (610) 420-3413, email@example.com