News

Today at the 2018 SCOPE Summit for Clinical Operations Executives, DrugDev (an IQVIA company) unveiled the industry’s first truly SaaS solution for electronic patient informed consent. Consent Engineering, the latest addition to the DrugDev Spark™ clinical operations suite, provides all the proven benefits of standard eConsent with the added ability for sponsors and CROs to develop robust and scalable consent systems without having to rely on external providers.

For the first time, Consent Engineering on DrugDev Spark gives study teams the tools, training and best practice resources they need to create, manage and automate consent solutions in-house. This new ability significantly streamlines the time and cost of development and implementation, enabling sponsors and CROs to bring the proven benefits of eConsent to millions more patients worldwide.

eConsent systems already are transforming patient satisfaction and retention, study team efficiency, and regulatory compliance in clinical trials worldwide. DrugDev introduced the life sciences industry to eConsent in 2005 and has since partnered with leading pharmaceutical companies and clinical research organizations (CROs) to implement solutions on over 100 studies.

“Our mission here is not to do eConsent a little bit better, but to fundamentally change how sponsors and CROs manage consent by giving them the power to build and manage a full consent system,” said Eric Delente, President, Patient Consent at DrugDev. “Consistently across companies, consent is one of the most frequent areas of audit findings, which can cost companies significant time and money to resolve. We’re helping sponsors and CROs fix their processes by eliminating inconsistent spreadsheets that grow to be several gigabytes in size and are impossible to track accurately. We’re removing the burden of version control on literally thousands upon thousands of different consent forms to keep track of as amendments come out and patients need to be re-consented in dozens of different languages. We’re streamlining the schedules and expenses of relying on external vendors for every trial. And we’re changing the game so the same effort they currently use to author ICFs in Word and email is now directed into a controlled content management system. Finally, we’re putting consent into the hands of sponsors and CROs so they can get it into the hands of more patients, and faster, than ever before.”

Features and benefits of the DrugDev solution include…

• Centralized ICF authoring, review and approval processes with uncompromising version control
• Intuitive structured form fields, progression checks and wizard capabilities
• Guided ICF creation using templates, Word documents, prior ICFs, or built from scratch
• Unlimited trials, add/remove sites, manage access controls, and more
• Flexible deployment onto any tablet or device at sites, including those already in use (e.g. ePRO/eCOA)
• Configurable role-based workflows (due dates, checklists, audit trails) and document attributes at the country and site level
• Robust API for facilitated integrations with IXRS, CTMS, EDC, eTMF
• Ability to output paper consent and/or eConsent (with eSignature or print-to-sign) per individual study needs and country requirements

“We’ve been doing eConsent for a long time, and it’s extremely important that the consent process is tailored to your patient population to ensure all patients understand and are comfortable with the trial,” added Delente. “Now, we’re finally bringing this capability directly to sponsors and CROs by equipping them with tools which are as simple to use as an office program like Microsoft Word and which guide them to create, update and track ICFs in a fully validated environment. By removing the time and cost barriers typically associated with external providers that prohibit its use on certain trials, Consent Engineering will enable more patients than ever to take advantage of greater understanding and satisfaction. Personally, I believe this move to SaaS will be just as impactful as the leap from paper to electronic methods, and that Consent Engineering will forever change how patient consent is done worldwide.”

To learn more about Consent Engineering, visit DrugDev’s booth #400 at the SCOPE Summit for Clinical Operations Executives in Orlando (Feb 12-15, 2018) or schedule a demonstration at drugdev.com.

About DrugDev
DrugDev, an IQVIA company, helps the world do more trials through industry-wide collaboration, standardization and a beautiful technology experience. DrugDev Spark™, the unified clinical operations suite, is comprised of proven solutions used by over 100 sponsors and CROs on over 2,000 clinical trials to transform the quality and efficiency of clinical trials from startup through closeout. DrugDev Spark is powered by the DrugDev Golden Number, the award-winning universal identifier for global site facilities and investigators used by TransCelerate and the Investigator Databank. Learn why 9 of the top 10 sponsors and 4 of the top 5 CROs trust DrugDev by scheduling a demo of DrugDev Spark at drugdev.com.