Harvard Clinical Research Institute (HCRI), a world-renowned academic research organization, has expanded its endpoint adjudication services – and significantly reduced the timeline to complete the process – by implementing eClinicalOS (eCOS), a multi-faceted, cloud-based clinical trials solution from the eClinical division of Merge Healthcare (NASDAQ: MRGE).
An endpoint is an event in or result of a clinical trial that helps measure whether the treatment under investigation is safe and/or effective. Some examples of endpoints may include increase/decrease of symptoms, improvements in quality of life, or a serious event such as a stroke or heart attack. When endpoints are captured in clinical studies, oftentimes an independent, unbiased group of experts (called an Event Adjudication or Clinical Events Committee) is engaged to review the outcomes data and give their expert opinions. Endpoint Adjudication (EA) by a single entity is an important part of a clinical trial because it helps to reduce variation in the interpretation of outcomes and events – a benefit that is especially helpful for regulatory agency review.
The “old way” of performing EA in the industry was cumbersome and manually intensive. Thick binders (called dossiers) were compiled and shipped for every event, creating lag time for those individuals who were required to act upon the information. The introduction of the online Endpoint Adjudication Module (EAM) from eCOS changes that. Unique in the industry, the EAM allows organizations like HCRI to create a fully digital “paperless workflow” for adjudicating study endpoints. It gives all stakeholders real-time, online access to the study status, data, documents, and adjudication determinations based on their roles and permissions.
During 2015, HCRI successfully implemented the EAM in the eCOS platform.
“Before eCOS, we had very highly regarded endpoint adjudication processes, but we were still performing many tasks in a manual fashion,” said Michelle Escarfullery, business manager for Clinical Review and Safety. “With the eCOS EAM, we’ve cut our timeline by an average of 30 percent.”
He also noted that the EAM’s flexibility was a primary factor in HCRI’s selection of eCOS. “Number one, we needed an option that would let us tailor aspects of the workflow to our needs, and eCOS fits that perfectly,” Mr. Escarfullery said. “For example, we can now easily modify adjudication forms to match the needs of specific studies. The module’s ability to let us customize eCRF pages means that our team can collect source documents and translate them into multiple languages in one central location.”
Elaine Catapane, HCRI’s director of Clinical Review and Safety, highlighted another advantage of the eCOS platform and endpoint adjudication module for the organization. “Because we conduct studies around the world, having a cloud-based database empowers us and our partners to work in a truly unified global workplace” she said.
The benefits of the eCOS platform also extend to HCRI’s many sponsors. “The built-in quality control measures and ability to give our sponsors visibility into the process helps us strengthen our sponsor relationships and continue to grow as an organization,” said Spencer Goldsmith, president of HCRI.
“Our goal is for eCOS to be the industry’s standard platform regardless of a study’s size, complexity or location,” said Zaher El-Assi, president of the eClinical division of Merge Healthcare. “We’re exceptionally pleased to expand our relationship with HCRI, one of the world’s preeminent academic research organizations. We’ve seen firsthand the power of our core adjudication solution for driving success at the sponsor level, and we’re thrilled that HCRI will be taking advantage of our platform.”
About Harvard Clinical Research Institute
Harvard Clinical Research Institute’s (HCRI) mission is to improve health and quality of life by collaborating with academic and industry sponsors to conduct high-quality clinical research in a professionally nurturing and world-class academic environment. HCRI accomplishes this by collaborating with a diverse network of academic researchers to offer expertise in a broad range of therapeutic areas. Since 1999, HCRI’s CEC has provided sponsors with high quality and consistent adjudication of reported endpoints and is built on the foundation of expertise, leadership, quality, and experience. Examples of this include the conception and leadership of numerous Academic Research Consortia (ARC, VARC, and BARC), adjudication and analysis for FDA special panel meetings, and the support of over 100 successful PMA and NDA submissions.
HCRI is known to have extensive experience in Cardiovascular devices and drugs, and also has experience in Psychiatry, Heart Failure, Hepatology, and Nephrology. More information is available at http://www.hcri.harvard.edu/.
About the eClinical Division of Merge Healthcare
The eClinical Division of Merge Healthcare is a leading provider of study and data management systems. eClinicalOS (eCOS), the company's flagship product, is a single, scalable, cloud-based platform researchers can configure to suit a study's precise needs. From monitoring inventory and managing randomization to endpoint adjudication and archiving results, users pay only for the options they use. Studies built within eCOS can launch in as few as 10 days, and the average deployment time from project start is 40 days. Through active sites in 80-plus countries, more than 50,000 clinical research professionals in small and large organizations have entrusted their study management needs to eCOS. The division also provides CTMS for Investigators, the first clinical trial management system. More information is available at www.eclinicalos.com, and you can follow us at @goecos.
Merge is a leading provider of innovative enterprise imaging, interoperability and clinical systems that seek to advance healthcare. Merge's enterprise and cloud-based technologies for image intensive specialties provide access to any image, anywhere, any time. Merge also provides clinical trials software with end-to-end study support in a single platform and other intelligent health data and analytics solutions. With solutions that have been used by providers for more than 25 years, Merge is helping to reduce costs, improve efficiencies and enhance the quality of healthcare worldwide. For more information, visit merge.com and follow us @MergeHealthcare.