Science/Nature

Medable Launches TeleConsent for Clinical Trials to Streamline Approvals During Decentralized Trials – MedLancr

What You Should Know:

– Medable launches Teleconsent, part of its Telehealth
family of cloud-based software for decentralized clinical trials.

– The application represents the next big step in
enabling fully virtual trials and is key to patient-centric trial design
because it allows patients to handle the lengthy process of consenting – and
re-consenting – to trial participation conveniently from anywhere.


Medable Inc.,
a 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.

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.

Medable TeleConsent: The Next Piece of the Decentralized
Trial Puzzle

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.

Why TeleConsent Is Critical During COVID-19

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.

Design Approach

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.  

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.

“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.”

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