Orbus Therapeutics, Inc., a private, clinical-stage biopharmaceutical company focused on the development and commercialization of therapies that treat rare diseases, has selected DSG, a leader in electronic data capture (EDC), to provide a fully supported eCaseLink EDC system including IWRS Web-based randomization and local lab technology for a global Phase 3 trial for patients with recurring Anaplastic Astrocytoma.
DSG’s eCaseLink will allow Orbus 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.
“The approach in use by Orbus Therapeutics represents some of the most innovative cancer research in the country, and we are proud to support those efforts,” said Tony Varano, CEO of DSG. “The selection of DSG by Orbus reaffirms our state-of-the-art user-friendly EDC technology often deployed in oncology and orphan condition studies.”
eCaseLink IWRS, an integrated component of the EDC software, will allow Orbus to 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 Orbus with clean, timely, and cost-effective deliverables throughout the lifespan of the study. With 24 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/verification 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 Orbus Therapeutics
Orbus Therapeutics, Inc., a private, clinical-stage biopharmaceutical company is dedicated to developing products that treat rare diseases for which there are few, if any, effective therapies. The Company’s product candidate in clinical development is eflornithine. Eflornithine is a novel cytostatic agent, which the Company is developing to treat patients with recurrent anaplastic astrocytoma, a rare form of central nervous system cancer. Eflornithine irreversibly inhibits ornithine decarboxylase, a key enzyme in mammalian polyamine biosynthesis that is up-regulated in certain types of cancer. For more information, please visit the Company's website at http://www.orbustherapeutics.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 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: www.dsg-us.com.
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Last updated on: 30/09/2016
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