Clinical trial technology provider has broadened its Lumenis eSource offering to include an eConsent module. The feature is intended to give clinical trial managers greater access to data, including from decentralized locations.
Challenges with consent
Doug Pierce, president and co-founder of Clinical Ink, told Outsourcing-Pharma that proper handling of informed consent documents (ICF) is an all-too-common struggle for site managers.
“It is important that patients have signed the correct version of the ICF before proceeding with the study. As new versions are published, the site must make sure that patients who have signed previous versions re-sign the new version, and they must ensure that new patients sign the most recent version. Failure in either of these regards is a serious issue,” he said.
Pierce added the eConsent module serves to reduce such challenges with automated release of new eICF versions.
“When the tablet comes online and a new eICF is available, it is downloaded to the tablet and ready to use. Sponsors are able, remotely, to verify that patients have signed the correct version, reducing both the cost of site visits and the time required to review ICF status,” he said.
Pierce added that the module also fully supports virtual trials, in which the patient reviews and signs an eICF offsite.
Streamlined data management
In addition to eConsent, the Lumenis platform includes modules that handle direct-data capture, electronic clinical outcome assessment, and electronic patient-reported outcome.
According to the company, Lumenis makes it possible for research teams to remotely monitor data and documents immediately, avoiding long waits for on-site monitoring. Previously, the firm had integrated third-party eConsent tools. This module permits seamless integration with the data capture function, the company said.
Clinical Ink CEO Ed Seguine said in light of the European Medicines Agency’s (EMA) recent qualification opinion supporting eSource DDC in clinical trials, more streamlined eSource technology is necessary, and beneficial, for trial sites.
“A unified, eSource technology must be considered by innovative companies to advance global clinical research. Not only are your sites and patients assured of an easier experience, but you can be certain your protocol is executed correctly,” he said.
Additionally, the Lumenis technology offers support services and features that can be tailored to fit specialized therapeutic areas, such as lupus, gastrointestinal and central nervous system diseases, dermatology, and oncology.
