The electronic consent (eConsent) solution, TrialConsent, can integrate with electronic clinical outcome assessment (eCOA) or stand alone.
Jeff Lee, product lead, patient engagement and eConsent at CRF Bracket, said the new secure password-protected login account feature for patients is important. “Optimizing how this gets handled allows for the patient to pause/resume during the consenting process, which is a key patient-centric design feature,” he told us.
This login feature – not available on the company's other eConsent systems – eases the patient experience during re-consent, said Lee. He added, “Patients and their families are also given the opportunity to flag any concerns or questions on the documentation and resolve these before providing their consent on a trial.”
Since the remote study model was pioneered by Pfizer in 2012, and given “an additional bolt of interest” by ResearchKit in 2015, Lee said most initiatives have had “fairly modest ambitions,” targeting observational studies “where the expectations for study conduct are more forgiving.”
Still, demand for remote studies has steadily increased over recent years, he said.
“Increasingly, sponsors have come to recognize that fully virtual studies are less realistic. It’s more likely that studies will become ‘semi-virtual,’ where some of the visits are supported remotely, but some still occur at the study site,” explained Lee.
He added, “In a way, this realization takes the pressure off the industry to fully resolve challenging issues associated with remotely joining a study, such as how to remotely verify the patient’s identity and direct-to-patient drug supply.”
Lee said this should prompt more use of remote study activities in standard interventional studies.
“Since we have randomization, eConsent, patient engagement, eCOA, drug supply management, all within a single organization, we feel a responsibility to push ourselves to solve these difficult challenges and help the industry achieve breakthroughs around fully or partially virtual studies,” he added.
Moving forward, Lee said the company’s roadmap includes “multiple additional enhancements” to its current support of the remote study model.
CRF Bracket recently closed its first full quarter as a combined entity, after the private equity firm behind Bracket purchased CRF Health in July 2018. The company saw more than a 20% increase in new clinical trial business in the quarter and will “aggressively look for partners” from its current and future customers, CEO Mike Nolte told us at the time.
