MALVERN, Pa.--(BUSINESS WIRE)--DSG, a leader in electronic data capture (EDC), has teamed up with Soligenix to provide EDC, IWRS Web-based patient randomization and data management services for their current Phase 3 clinical study of SGX301 (synthetic hypericin) coupled with visible light activation in the treatment of Cutaneous T-Cell Lymphoma.
eCaselink significantly increases clinical trial management speed while reducing study management cost. A truly integrated solution, DSG’s eCaselink seamlessly combines EDC, Risk-Based Monitoring, eSource, ePRO, IWRS, 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.
eCaseLink IWRS, an integrated component in the EDC software, will help Soligenix manage randomization and subject enrollment in their clinical trial. DSG will manage all aspects of clinical study data management from database setup through lock. DSG's data management team will add value to their EDC service by providing Soligenix with clean, timely, and cost-effective deliverables throughout the lifespan of the study. With 23 years of clinical trial software and services experience, DSG will provide value added services including the development and design of customized databases, design and review of eCRFs, data validation/verification programming, comprehensive data management plans, ongoing review of data and logic checks, laboratory data management, data encoding, reconciliation of serious adverse events, and database lock, submission and archiving. Soligenix has found that taking advantage of the eCaseLink end-to-end integrated product suite, combined with the knowledge and commitment of the DSG team, is helping them reach their clinical trial goals.
“We are pleased to assist the very experienced and knowledgeable Soligenix team in battling this dreadful disease,” said Tony Varano, CEO of DSG, Inc. “DSG is very confident in the successful conduct of this clinical trial and looks forward to contributing to the fight against lymphoma.”
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense. Our BioTherapeutics business segment is developing SGX301 as a first-in-class photo-dynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn’s disease (SGX203) and acute radiation enteritis (SGX201), and our novel innate defense regulator technology (SGX942) for the treatment of oral mucositis.
Our Vaccines/BioDefense business segment includes active development programs for RiVax™, our ricin toxin vaccine candidate, VeloThrax™, our anthrax vaccine candidate, OrbeShield™, our GI acute radiation syndrome therapeutic candidate and SGX101 and SGX943, our melioidosis therapeutic candidates. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax™. Currently, this business segment is supported with up to $57 million in government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA). Additionally, Soligenix has an exclusive worldwide collaboration with Intrexon Corporation (NYSE: XON) focused on the joint development of SGX101 for the treatment for melioidosis.
For further information regarding Soligenix, Inc., please visit the company's website at www.soligenix.com.
DSG, Inc. 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, Clinical Supply Systems, 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: www.dsg-us.com.
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