eConsent
eConsent
Patients
Phase III trials have highest deviations, involving approximately 1/3 of patients in trial1
Amendments
Protocols with 3+ amendments add 3 weeks to planned treatment duration,
on average1
Oncology trials
70% of Oncology trials Suvoda supports have at least one amendment2
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.
Reduce regulatory risk, administrative burdens, study delays, and excess 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.
eConsent
Trials conducted
with 75% in oncology, rare disease, and CNS
Countries supported
with trial sites in thousands of locations
Client satisfaction
year after year, in our annual company survey
Built on our single clinical trial technology platform, Suvoda eConsent and IRT drive seamless, automated control
To your study and site users, our eConsent application 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, our 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.
An added benefit to this unified approach? It can enable deployment of the Suvoda eConsent application within 3-5 business days of your consent document approval.
Meet differing global consent requirements with flexible eConsent features and functionality
Do you need to offer an electronic signature in most countries, wet-ink upload in some others, and print-and-sign in yet a few more? Will you have to accommodate multiple consent types—subject, caregiver, legally-authorized representatives—in multiple languages? Are you looking to make consent documents available on multiple devices, both on site or at home? And do you want all these options on any one trial?
No problem. Like the Suvoda IRT, our web-based eConsent was designed for the most complex clinical trials, with the flexibility you’ll need, built right in.
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’s 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 your Suvoda IRT system.
We know that if you can’t measure it, you can’t manage it. That’s why our Suvoda eConsent application 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 consents 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
1January/February 2022 Impact Report, Tufts Center for the Study of Drug Development.
2Suvoda data and customer interviews