MALVERN, PA — DSG, Inc. is supporting two Phase 3 studies sponsored by Romark, L.C. to evaluate an investigational new drug for prevention of COVID-19 in elderly residents of long-term care facilities and healthcare workers.
Given the urgent nature of the COVID-19 pandemic, getting a trial up and running fast is crucial but even more critical is to build a trial that is adaptive with all the uncertainties and challenges of the current situation. DSG, with 28 years of experience in this industry and best-in-class service provided by its team, bringing to bear its full suite of eClinical software tools within its flagship eCaseLink™ product line, including tools to build a traditional, virtual or hybrid trial, is the perfect partner to identify and provide the ideal solution.
Romark needed multiple systems including EDC, IRT and ePRO with built-in capabilities for Centralized Monitoring to meet the trial requirements. These studies had to be adaptive and flexible to accommodate the ever-changing COVID-19 landscape. The need was for a team who would be an extension, understanding the needs and challenges and aligning the protocols with existing products to create an efficient and effective solution. DSG provided the right mix of experience in working quickly through challenging scenarios while considering all potential contingencies, and then able to design, build, launch and support complex interoperable clinical data collection and monitoring systems merely within days during the pandemic; also with enough flexibility to ensure the success of these trials.
First introduced in 1999, eCaseLink combines Participant Registration, eConsent, eSource, EDC, IRT/IWRS/RTSM, eCOA/ePRO, Telehealth, Risk-Based and Remote Monitoring, CTMS and Safety into a single system that is module-based and patient-centric, built for all web-connected devices such as tablets, smart-phones, laptops and desktops. eCaseLink provides the fastest start up, quickest database lock, and most rapid FDA submissions resulting in a measurable ROI. The enhanced interoperable API based on the CDISC ODM allows eCaselink to work with other trial applications used across a study enabling sponsors and CROs to completely work within a functional service provider model.
“Being a part of the solution in the fight against COVID-19 pandemic, by working along with our great partners at Romark is an honor,” said Tony Varano, CEO at DSG. “This pandemic is triggering an unprecedented set of events around the world and disrupting our industry. Our team at DSG is committed to providing assistance to any company in the healthcare domain, using our award-winning software suite and resources to mitigate the impact on their existing or upcoming trials.”
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