An imaging capability integrated with its clinical software suite has earned trial technology provider PharmaVigilant a contract with TissueGene. The regenerative-medicine maker is running a Phase II study for a drug candidate to treat a degenerative joint disease of the knee.
MRIs, typically too large to be opened in an EDC system, provide a method of determining biomarkers for use in drug development, says the software company. Integration of MRIs with trial data systems reduces the number of steps that researchers take to access and review the images. It lets sponsors manage our trial participants' MRIs "through one integrated solution with a single login, rather than relying on a separate organization to provide these capabilities," says Kwan Hee Lee, CEO at TissueGene, in an announcement.
PharmaVigilant's system is called I-Vault. Its subsystems correspond with the company's view of two submission components for clinical trials: I-Vault eTMF (electronic trial master file) is a repository for site- and patient-related data. The I-Vault rSDV (remote source document verification) system provides data monitoring independent of site visits.
- here's the announcement