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PharmaVigilant has been selected by Synergy Pharmaceuticals Inc. to support its one-year, multicenter Phase II study focused on the development of a new drug to treat gastrointestinal disorders and diseases. Synergy will be implementing PharmaVigilant's Inspire EDC System, Clinical Data Warehouse, Investigator Portal and I-Vault eTMF system to support the preparation, conduct and closeout of their Phase II gastroenterology clinical trial, scheduled to begin in mid-February 2010.
According to Craig Talluto, PhD, Executive Director of Clinical Development, Synergy Pharmaceuticals, Inc., "We wanted to partner with a technology provider that would help us easily manage the collection and maintenance of our trial data, without costly delays and inefficiencies. We selected PharmaVigilant's technology suite not only because of the significant cost savings, but also because this technology allows enhanced transparency and access to our data, which will empower us to minimize any potential bottlenecks and delays."
"We're proud that our technology will play a role in helping to bring a significant new treatment to market for those suffering from debilitating GI conditions," said James DeSanti, Founder and Chief Executive Officer, PharmaVigilant.
This project will include the development of an electronic Investigator Portal to facilitate the site selection and initiation process and to provide a common interface and access for all sites and users for the duration of the trial. PharmaVigilant's I-Vault electronic trial master file system will help Synergy to facilitate site startup and IRB submissions. Through this partnership, Synergy will also have unlimited access to its clinical data in the I-Warehouse using PharmaVigilant's InSpire Reporting Tool.
PharmaVigilant offers a full suite of clinical trial technology offerings including Electronic Data Capture (EDC), data warehousing, study building (I-Builder 2.0), Electronic Trial Master File System (eTMF), Remote Source Document Verification (rSDV), study administration and an automated site payment system. PharmaVigilant focuses on Phase I-IV clinical trials, registries and other post-marketing studies. The technology has supported more than 200,000 patients in 14 countries across North America, Europe, Asia and Australia and continues to expand rapidly.