The software as service (SaaS) tool –Informed Consent Form Author –enables sponsors, sites, and contract research organizations (CROs) to view an online portal and produce informed consent forms (ICF) for delivery via eConsent or traditional paper.
Eric Delente, general manager of Patient Consent at IQVIA told us, “Simply put, we wanted the industry to know that there is an easy way to implement eConsent without cost and schedule implications.”
Trial transparency, a movement in the clinical trial sector aimed to make research knowledge more readily available often relies on eConsent. Delente told us, “Trial transparency has been paramount for eConsent since its inception, as the rich, unalterable audit trails facilitate visibility and confidence into the consent process.”
“While the consent process must ultimately be the responsibility of the investigator, transparency is challenged by the traditional paper-based ICF process, where essentially a signed piece of paper and some notes are often all that are available,” he added.
Through the software, visibility into the ICF development process is available. Thus, the protocol to which the patient has consented to is also visible. “It's critical that all stakeholders in a clinical trial - including patients – be able to easily understand how a protocol and ICF has changed over the course of a study,” said Delente.
The ICF Author uses configurable workflows, checklists, and automated version control to manage and track authorship, review, and approval processes. According to Iqvia, this “dramatically improves” visibility and transparency leading to improved compliance.
Iqvia said CROs will be able to use the configurable workflows as a way of preventing accidental omissions before “they become a major problem.”
Research solutions restructured
The company also recently launched a new suite of virtual study options to challenge clinical research mindsets.
The virtual study suite powered by the Iqvia Study Hub, houses workflows, supports patient communications, stores documentation, captures study activity, and telemedicine visits.
Richard Staub, president of research and development solutions at Iqvia said at the time, “In a time where connectivity is transforming every industry, it’s time for one of the most critical functions in the biopharmaceutical space to evolve and take it to the next level.”
