When setting out to provide clinical trial technology solutions for pharma and biotech, James DeSanti, founder and CEO of PharmaVigilant, carefully scrutinized the landscape because, as he puts it, “Who really wanted another EDC vendor?”

That was in 2006. Now, almost 2010, DeSanti is ready to go prime time with PharmaVigilant’s suite of trial module offerings. To be sure, the product modules have been already been used in Phase I through Phase IV trials, rescue studies and registries by biotech and pharma. But PharmaVigilant has been on low profile in the eClinical space. This is based in large part on the company’s philosophy and a conservative background that comes direct from DeSanti’s lengthy pedigree in pharmaceutical marketing.

DeSanti has spent 20 years in the pharma industry including time with J&J in product development and launches, and later president of Walsh Americas, which used patient data to determine market success of drugs. His resume is peppered with international startups and executive management. It was when he joined Phase Forward in 1999 that he first worked directly with clinical trials. When he left the company in 2002, he knew that industry needed solutions; and wanted to drive the business toward aligning with sponsors, much like Phase Forward. The solutions he envisioned would have to have the EDC underpinning but would be forward-facing. “These are not back end systems. These are tool sets that can be utilized by those that need the information.”

Forward Facing
After acquiring a large system developed by Cognizant from advertising and marketing conglomerate Omnicom (not to be confused with Florida-based clinical trial technology provider OmniComm Systems), PharmaVigilant set to work on the rest of its forward-facing philosophy. To date, its modules include:

• InSpire, its EDC system with features for industry and end users
• I-Warehouse: A commercially available data warehouse, providing analytics across multiple trials
• I-Vault eTMF: Electronic Trial Master File System (eTMF) that offers a fully integrated end-to-end solution for clinical development and submissions
• I-Vault rSDV: Remote Source Document Verification (rSDV) offers ongoing data monitoring independent of site visits
• Inspire Control Center (ICC): A study administration tool for study start up, versioning and on-going maintenance for sponsor’s complete portfolio of studies
• I-Builder: Creates and validates study builds, reducing the time it takes to build a trial
• PaySite: Automated site payment for reporting and time to site payment reduction

These modules don’t necessarily fall into what we’ve come to define as traditional eClinical categories. Instead of a data repository, it has a data warehouse that provides analytics to everyone, not just the few with access to the warehouse. Instead of CTMS it has a study administration tool targeted at study startup activities and maintenance for a complete product portfolio of studies. Two modules have the possibility to change the way sponsors and sites relate to each other. Those are I-Vault rSDV, which allows ongoing data monitoring independent of site visits and PaySite, which automates site payments and reporting. rSDV, or remote source document verification, can “cut the time on site by almost 50%...resulting in substantial savings,” said DeSanti. In fact, when the product was used prior to rollout, PharmaVigilant solicited feedback from sites and sponsors. According to DeSanti, the sites were pleased that monitors were not always showing up at their offices. And for sponsors, they were able to identify underperforming sites more quickly. DeSanti is completely comfortable with his company’s conservative marketing approach, even as pharma reinvents the way it needs to do business. “Fundamentally, the pharma industry is not changing its goal to provide new drugs to market,” said DeSanti. “R&D is changing. It’s no longer the sacred cow. All the resources it needs will be provided and the tool sets will be provided and adopted to achieve efficiencies.” And while technology will be necessary to feed the new breed R&D, it is its understanding of pharma’s ways that may set PharmaVigilant apart. “Each pharmaceutical company cultures’ are different. And you have to understand how to align with them. And you need to understand they need a high level of quality,” said DeSanti.