SCDM Selects DSG'S eCaseLink EDC Randomization Solution as the Winner of Their First Annual Data Driven Innovation Award.MALVERN, Pa. -- DSG DSG Direct Shift Gearbox (Audi)
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DSG Duke Student Government (Duke University) , Inc. today announced that its collaborative work with Sirion Therapeutics using its eCaseLink EDC EDC
See: Export Development Corp. software was selected as the winner in the 2007 Society of Clinical Data Management's (SCDM SCDM Society for Clinical Data Management
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SCDM Self-Contained Dispensing Mechanism (nuclear warhead) ) first annual Data Driven Innovation Award competition. DSG, Inc. supports clinical trial data collection globally through its eCaseLink EDC software, electronic patient diaries, and Clinical Trial Management Systems software. Sirion Therapeutics is an ophthalmic biopharmaceutical company.
DSG was recognized for developing patient randomization randomization (ranˈ·d·m , drug delivery and supply management, and reconciliation in real-time as base functionality in DSG's eCaseLink EDC product. DSG developed this functionality working in partnership with Sirion, which specifically defined the functionality that they required for this solution. Sirion Therapeutics' investigative sites were able to perform all patient randomization, drug accountability, and EDC tasks in one fully integrated system, and no longer needed to use multiple systems with multiple vendors to provide this functionality. It was also demonstrated to the judges that DSG and Sirion Therapeutics successfully deployed this innovative technology in six studies, and that the data was captured via tablet PCs as eSource.
"We are honored to be recognized by SCDM for this innovative solution. We provided Sirion Therapeutics the best of what EDC can offer in terms of functionality and integration," stated Tony Varano, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of DSG. He continued, "All innovative solutions start with our customers. We delivered the functionality that Sirion needed in eCaseLink--a fully integrated randomization and drug module. To satisfy our customers' requirements and provide them with enormous savings is what software development is all about."
"We were able to utilize our staff's background in the development of online data capture systems in collaboration with DSG to leverage technology which resulted in more efficient processes," said Kimberly McLeod, vice president of clinical operations at Sirion.
Through DSG's partnership with Sirion, eCaseLink EDC technology was developed to randomize ran·dom·ize
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment. subjects and issue investigational product in real time, enabling continuous reconciliation to occur and minimizing the need for additional external reconciliation. This completely replaced IVRS IVRS Interactive Voice Response System
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IVRS Ironside Volunteer Rescue Squad (Maryland) and associated costs. Specialized edit functionality, specific only to eCaseLink software, warned users instantly of problems before submission to the database, which sped the process and reduced transcription errors that may otherwise have occurred. Additionally, Sirion deployed tablet PCs to allow clinicians to enter data in real time with no paper source, greatly reducing transcription errors.
DSG, Inc., headquartered in Malvern, PA, has been supporting clinical trial data collection with innovative technology solutions including EDC, electronic patient diaries and digital on-demand CRF CRF
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CRF Chronic renal failure publishing management software since 1992. DSG's products allow user-friendly, accurate and efficient data capture at any investigator site regardless of the site's technological infrastructure. DSG has successfully supported over 400 clinical trials for more than 300 companies, at over 18,000 sites with more than 200,000 patients worldwide. For more information, please visit www.dsg-us.com.
Sirion Therapeutics is a privately held biopharmaceutical company pursuing the discovery, development and commercialization of products addressing unmet medical needs in the protection and preservation of eyesight. Sirion's pipeline includes four late-stage opportunities: ganciclovir, a topical antiviral for herpetic keratitis which is awaiting an NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any filing; difluprednate, a potent topical steroid in Phase III development for post-operative inflammation and uveitis uveitis
Inflammation of the uvea, the middle coat of the eyeball. Anterior uveitis, involving the iris or ciliary body (containing the muscle that adjusts the lens) or both, can lead to glaucoma and blindness. ; cyclosporine, a topical immunomodulator in Phase III testing for dry eye and fenretinide, a first-in-class oral vitamin A binding protein antagonist in Phase II development for geographic atrophy associated with dry AMD (Advanced Micro Devices, Inc., Sunnyvale, CA, www.amd.com) A major manufacturer of semiconductor devices including x86-compatible CPUs, embedded processors, flash memories, programmable logic devices and networking chips. . For more information, please visit http://www.siriontherapeutics.com.