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.
Reportedly, the project is expected to 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 seamless 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. The combination of transparency and access to its data with the streamlined startup and submission process translates into cost and time savings for Synergy.
James DeSanti, founder and CEO of PharmaVigilant, said: “Being selected to partner with Synergy on this important project is a testament to the strength of our solution. 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. I am confident Syngery will quickly find value in the flexibility, transparency and ease-of-use our technology suite offers.”