Only 53% of patients understand the potential for placebos in clinical research from informed consent documents i
Protocols with 3+ amendments add 3 weeks to planned treatment duration, on average i
Experience 100% visibility over consent and reconsent at all sites and for all patients
Reduce regulatory risk, administrative burdens, and study duration and expenses, created by mid-trial consent requirements.
In today’s complex clinical studies, informed consent isn’t just a first step in a patient’s clinical trial journey. It’s a process that must be repeated along the way, as the vast majority of protocol amendments require the patients to re-consent. The result is heightened risk of regulatory non-compliance, heavier administrative burden, and increased study expense and duration. In fact, according to the Tufts Center for the Study of Drug Development, trials with three or more amendments add on average three weeks to treatment duration.
When approximately 70% of the oncology studies we support have at least one protocol amendment, we believe the control and visibility of Suvoda eConsent make it a must-have tool for study and site teams—and their patients.
Improve patient comprehension. Reduce site burden. And decrease regulatory risk, delays, and expenses created by mid-trial consent requirements.
In today’s complex clinical studies, informed consent isn’t just a first step in a patient’s clinical trial journey. It is central to a patient’s understanding of study procedures and is a critical ethical requirement. And it is a process that must be repeated along the way, as the vast majority of protocol amendments require the patients to re-consent. The result is heightened risk of patient misunderstanding, regulatory non-compliance, heavier administrative burden, and increased study expense and duration.
When approximately 70% of the oncology studies we support have at least one protocol amendment, the patient experience and sponsor visibility of Suvoda eConsent make it a must-have tool for study and site teams—and their patients.
with 75% in oncology, rare disease, and CNS
with trial sites in thousands of locations
year after year, in our annual company survey
Powerful features that drive patient understanding and reduce regulatory risk.
Suvoda eConsent features robust functionality that gives patients the tools they need to understand complex study information. At the same time, the visibility over consent across all study sites and patients means sponsors have control over the full process to minimize delays and reduce the risk of a regulatory finding.
Built on our single clinical trial technology platform, Suvoda eConsent and IRT drive automated control.
To your study and site users, eConsent will simply appear as additional functionality within the Suvoda IRT system. Why? So that data is seamlessly shared, workflows are fully streamlined, and the process is completely controlled. We’ll simply upload your approved consent documents, and whenever a site user begins a study visit, IRT will automatically check in with Suvoda eConsent to confirm that the patient has consented to the latest. If not, a prompt within the IRT drives completion of the consent forms—a matter of just a few clicks within the same digital environment—before the visit is allowed to proceed.
A simple user experience across eConsent and IRT applications - for simplified training and workflow.
Clients have consistently given Suvoda IRT high marks for its minimalist look and feel, intuitive navigation, and patient-centric processes—and ability to drive focus on the immediate task at hand.
Suvoda eConsent has the same intuitive user interface, managed in the same digital environment as IRT. It enables study and site professionals to calmly and smoothly move from randomization and trial supply management (RTSM) activities to eConsent tasks and back again, without needing to sign onto a new system or significant additional user training. And their ease with the system should help patients find the informed consent process more accessible and understandable.
Gain real-time visibility to subjects’ consent status across all your sites, right in the Suvoda IRT system.
We know that if you can’t measure it, you can’t manage it. That’s why Suvoda eConsent maximizes transparency and visibility, compiling critical consent data and presenting it through our robust IRT reporting tools.
Identify, in real-time, the sites that are lagging in getting patients to consent to the latest versions. Digitally archive consent documents for compliance and audit. With full access to eConsent reports, study teams and field monitors can then take early corrective actions with outlier sites and verify consents were done properly without the need for physical visits. The result? Increased regulatory compliance and reduced risk of excluded patients and discarded data at the end of the trial.
FEATURED IRT MODULES