Supernus Pharmaceuticals Selects DSG, Inc. for EDC and IWRS in Phase 3 Clinical Studies on Impulsive Aggression in Pediatric Patients Treated for Attention Deficit/Hyperactivity Disorder (ADHD)

a leader in electronic data capture (EDC), was selected by Supernus
, 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
seamlessly combines EDC, ePRO,
Risk-Based Monitoring, eSource,
Randomization-Clinical Supply,
, 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

“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.”

, 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.

About DSG

supports clinical data capture and management with a
proprietary, organically integrated suite of award-winning user-friendly
technology solutions, including flagship eCaseLink™ EDC, Risk-Based
Monitoring, eSource, ePRO, IWRS Randomization-Clinical Supply Systems,
Drug Safety System, and CTMS. Since 1992, DSG has successfully supported
thousands of clinical trials for over 400 companies and 25,000 sites
across 93 countries, headquartered in Malvern, Pa., with additional
offices in the U.S. and Asia:

About Supernus

Pharmaceuticals, Inc.
is a specialty pharmaceutical company focused
on developing and commercializing products for the treatment of central
nervous system diseases. The Company has two marketed products for
epilepsy, Oxtellar XR® (extended-release oxcarbazepine) and Trokendi XR®
(extended-release topiramate). The Company is also developing several
product candidates to address large market opportunities in psychiatry,
including SPN-810 for the treatment of impulsive aggression in ADHD
patients. SPN-812 is being developed for treatment of ADHD.

All products and services above are the property of their respective


DSG, Inc.
Jack Minster, +1 484-913-2112