Suvoda has announced the general availability of eConsent as part of its unified platform, delivering a streamlined solution that allows clinical trial teams more electronic control over the consent process.
Remote monitoring and the flexibility for tracking consents, screening and randomisation data in a single place will be made possible by this offering.
It will boost real-time visibility, efficiency and ease of use while lowering regulatory risk and reducing the re-consenting burden throughout the trial process.
The company created an easily implementable solution that makes electronic collection and storing of consent documents hassle-free.
By offering real-time visibility and remote monitoring, the solution lowers potential issues associated with re-consenting and inspection findings linked to the complete informed consent process.
Despite the increasing virtualisation of trials, some countries do not permit e-signatures.
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By GlobalDataSuvoda eConsent provides the flexibility to incorporate differences in regulations by country, consent methods, consent types and device needs, resulting in a clear consent process to progress the trial.
It is one of three unified offerings on the company’s platform that aids patients, sites and sponsors in managing time-sensitive, mission-critical moments in life-sustaining trials.
By integrating eConsent with IRT technology on a single platform, sponsors could interactively share details of the trial with patients while enhancing subject enrolment, compliance and retention.
eConsent and IRT facilitate remote monitoring by aiding clinical research associates to evaluate data in reports using the portal without needing to go on-site.
Teams will be able to see each patient’s consent status across trial sites on a real-time basis and monitor other crucial consent parameters in addition to those tracked in IRT.
Suvoda CEO Jagath Wanninayke said: “Informed consent is a continuous process that must be repeated throughout a patient’s clinical trial journey, and no company is exempt from the possibility of lost data and time that re-consenting can bring.
“By listening to customers and patients throughout the early adopter phase, we have designed an eConsent solution that anticipates these challenges before they arise, while also simplifying the consent management with minimal or no changes to existing processes – both at the sponsor and the site.”
The latest development comes after Suvoda and N-SIDE entered a partnership agreement to provide integrated clinical trial optimisation.