Supernus Pharmaceuticals Selects DSG, Inc. for EDC and IWRS in Phase 3 Clinical Studies

DSG, a leader in electronic data capture (EDC), was selected by Supernus Pharmaceuticals, a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, to provide a fully supported eCaseLink EDC system, including IWRS Web-based Randomization-Clinical Supply, a Central lab and third-party CRO data integration, and data management services for two blinded Phase 3 clinical studies on impulsive aggression in pediatric patients being treated for Attention Deficit/Hyperactivity Disorder (ADHD). Leveraging pieces of DSG’s eCaseLink system (EDC and IWRS) will allow Supernus to significantly reduce clinical trial time, reduce trial cost, improve trial accuracy, and overall provide a more effective clinical trial with greater impact.

A truly integrated solution, DSG’s eCaseLink seamlessly combines EDC, ePRO, Risk-Based Monitoring, eSource, IWRS Randomization-Clinical Supply, Drug Safety, Site Payments and CTMS into a single harmonized system. DSG’s clinical study build tool makes initial EDC startup intuitive and fast, with unparalleled support services and hands-on training for self-build studies, used also by DSG’s team in providing full service SaaS software systems.

“DSG is extremely proud that Supernus has chosen the eCaseLink suite,” said Tony Varano, CEO of DSG. “We look forward to helping Supernus advance the treatment of central nervous system diseases through the use of embedded and transformational applications. This is further evidence that our eClinical solutions are not only leading from a technology perspective, but that our people, processes and product delivery remain the most highly trusted in the industry.”

eCaseLink IWRS, an integrated component of the EDC software, allows Supernus to manage randomization, subject enrollment, and drug supply in their clinical trial. DSG is managing all aspects of clinical study data management from database setup through lock. DSG’s data management team adds value to their EDC service by providing Supernus with clean, timely, and cost-effective deliverables throughout the lifespan of the study. With 25 years of clinical trial software and service experience, DSG expertly provides the development and design of customized databases, design and review of eCRFs, data validation programming, comprehensive data management plans, ongoing review of data and logic checks, local laboratory Normals maintenance, data management, data encoding, reconciliation of serious adverse events, and database lock, submission and archiving.