King of Prussia, PA – November 16 – DrugDev’s unified clinical operations suite enables leading sponsors and CROs to transform how global trials are run using innovative technology. With the company’s acquisition of SecureConsent, this leading platform now features the industry’s definitive eConsent solution, which is deployed on tablets and other mobile devices (including BYOD) to optimize site and patient convenience.
SecureConsent has been pioneering electronic informed consent since 2003 by working closely with patients, IRBs, CROs, sponsors, hospital systems, academic institutions and regulatory authorities to deliver the best process possible. The fully validated solution features multimedia education, real-time reporting and end-to-end document management to create better-informed patients, eliminate paperwork, simplify remote monitoring and ensure complete transparency for regulatory audits.
The eConsent team will continue to operate out of its headquarters in the Washington DC area, with SecureConsent co-founder Eric Delente assuming leadership and growth of DrugDev’s entire portfolio of patient solutions which also include feasibility and engagement capabilities.
“We’re working hard to put the ‘informed’ back into ‘informed consent,’” said Delente. “Prior to starting SecureConsent, we were focused on patient education for healthcare with a proprietary learning management system – so using familiar and efficient tools such as tablets to deliver easily consumed informational content was a natural extension from our initial mission and passion. We could not be more proud and honored to integrate our solution into the DrugDev suite in order to continue to help sponsors, CROs, sites – and now patients – to do more trials together.”
Considering 10-15% of audit findings are related to consent, there is significant risk for sponsors to rely on antiquated paper methods which lack control over the process – for example, ensuring patients sign the right documents, use correct dates, and acknowledge protocol changes.
“The common thinking used to be that paper is cheap, and works well enough because that’s what the industry had used for years – and sadly that’s true of many processes, not just patient consent,” said Hugo Stephenson, MD, DrugDev Executive Chairman and active principal investigator in Australia. “Thankfully, times have changed. Today we have a much better understanding of the staggering potential cost of resolving paper-based errors, and we have access to smart technology that enables us to fix these clearly broken practices. The impact our eConsent solution can have on monitoring costs and quality oversight are difficult to quantify but cannot be overstated.”
In recent years, support from patient advocacy groups and draft guidance from the FDA have served as catalysts for adoption of electronic informed consent. This heightened demand has necessitated rapid scalability of SecureConsent’s eConsent mobile solution, which over the past two years has been further developed under the guidance of Dr. Stephenson.
“We realized early on how much pent-up demand there was in the industry for a solution like ours, and that scalability would be a primary challenge to solve sooner rather than later,” said Delente. “Although we had several financing options, the moment we met DrugDev – including Ibs, Hugo and Brett Kleger, Chief Commercial Officer in particular – we were inspired by the similarities in our vision to help the world bring more drugs to market by easing the site and patient experience. By joining DrugDev, our solution will be a key part of a unified platform, rather than yet another standalone system, and frees us from worrying about company growth logistics so we can spend all of our time focused exclusively on creating the best eConsent solution possible.”
Ibraheem “Ibs” Mahmood, DrugDev President and CEO, said, “Eric and his team have pioneered the use of electronic informed consent and are true visionaries in the field, with customers successfully using the solution in real clinical trials every day. People who know me would say I have an unhealthy obsession with things that are new, but in this case I could not be more excited to add something that already exists. As of today DrugDev can provide our customers with direct access to the most proven, reliable and trusted eConsent solution available. We already know it works. Now we’re just making it easier for sponsors, CROs and sites of all sizes to get it.”
“Plus,” added Mahmood, “On a personal level, Eric wrote and recorded the strings section on Lenny Kravitz’s first three albums, which instantly elevates the coolness factor of our company several notches as well.”
To schedule a demo of the DrugDev eConsent solution, visit drugdev.com.
About SecureConsent (Part of DrugDev)
SecureConsent has been pioneering electronic systems for informed consent for global studies since 2005. The eConsent solution increases patient comprehension with multimedia education, enhances efficiency with remote centralized oversight, and improves regulatory compliance. The flexible solution supports numerous consent workflows and global regulatory environments as the forms and processes can be configured according to individual sponsor, study and site requirements. The fully-validated solution can run on virtually any device. Learn more at www.secureconsent.com.
DrugDev’s unified clinical suite enables sponsors, CROs and sites to do more trials through industry-wide collaboration, standardization and a beautiful technology experience. Featuring solutions for global site payments, site identification and activation, workflow optimization, learning management, and site and patient engagement, DrugDev helps companies transform the quality and efficiency of clinical trials from startup through closeout. The company also powers the revolutionary TransCelerate Investigator Registry and Investigator Databank collaborations with the universal identifier known as the DrugDev Golden Number. Learn more at www.drugdev.com.