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,a clinical trial technology provider, was recently selected by TissueGene to support a three-year, Phase II study to test the efficacy and safety of a new drug aimed at treating patients with a degenerative joint disease of the knee. TissueGene, a privately-held biopharmaceutical company with a pipeline of promising regenerative medicine therapeutics in the field of cell-mediated therapy, chose PharmaVigilant as a result of its integrated imaging capability in I-Vault.
Too large to be opened in traditional EDC systems, MRIs are a vital imaging method to determine biomarkers for all phases of drug development. Embedded into one single system, PharmaVigilant's capability allows MRIs to be integrated into the clinical trial process, streamlining the storage, access and readability of the images. By integrating this imaging capability into its I-Vault solution, PharmaVigilant provides TissueGene researchers and trial end users, such as radiologists, with a single login, significantly improving access and control of the trial's MRIs. This is a marked difference from other technology vendors who rely solely on their partnerships with other organizations to provide MRI imaging capabilities to sponsors and require additional steps and processes to manage and view images.
"I-Vault provides us with the opportunity to manage our trial participants' MRIs through one integrated solution with a single login, rather than relying on a separate organization to provide these capabilities," said Dr. Kwan Hee Lee, President and CEO of TissueGene. "Access and control over one's data is critical when conducting clinical trials, and we value the opportunity to retrieve our data through a streamlined and secure process. This has increased the efficiency of trial processes and improved the quality of the data while yielding significant cost savings. Combined, these factors will help us effectively determine the efficacy and safety of this new drug."