Advarra, the market leader in regulatory review solutions and clinical research technology for sites and sponsors, announced a new site-specific eConsent module in the Advarra clinical trial technology portfolio. The integrated solution extends the connectivity of Advarra’s site technology across stakeholders – from sites’ eRegulatory systems to sponsor and CRO trial systems and study participants – to reduce operational friction. Patients benefit from a smoother, digital clinical trial enrollment experience, participation optionality, and expanded, remote access to clinical research opportunities.
“With Advarra eConsent, trial participants enjoy a more seamless consent process, allowing them to consent wherever is most convenient,” said Stacey Banks, Director of Inova Health System’s Clinical Research Support Office. “It allows patients to consent remotely without having to create a log-in or password, while enabling secure access to the latest form without extra trips back and forth to the site.”
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Advarra’s new eConsent module also makes it easier for sites to compliantly manage a complicated and ongoing consenting process throughout the duration of the trial. “Informed consent forms can change frequently, burdening sites with version control to stay current or risk protocol deviation. If a site inadvertently consents a participant using an expired form,” explained Banks, “it must notify multiple regulatory authorities and re-burden the patient to consent all over again.”
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Now, with the eConsent module within Advarra eReg, site staff only need one log-in credential rather than signing into a new system, streamlining the process. System connectivity also ensures that the patient always has access to the latest consent form, giving sponsors confidence in site adherence to the protocol and regulatory requirements as new ICFs are automatically routed from Advarra’s IRB system, CIRBI, to eRegulatory and eConsent systems. And sites can leverage integrated protocol information from their OnCore or Clinical Conductor CTMS to further streamline the consent management process.
“We are focused on the connected ecosystem, integrating technology into every facet of clinical research while being thoughtful about the experience for the site and patient,” said Elisa Cascade, Chief Product Officer at Advarra. “Sites most days are engaged in a swivel chair effect, switching between systems as they serve patients and conduct trials. Our new eConsent module improves the clinical trial experience by allowing sites to operate in their own technology and by providing patients with access to their own consent information during a trial.”
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