SOURCE: PharmaVigilant


November 03, 2009 08:30 ET

PharmaVigilant Demystifies Clinical Trial Process Costs and Improves Access to Data by Offering Sponsors Complete Visibility

Total Visibility Into Clinical Trial Process -- Cuts Inefficiencies and Eliminates Unnecessary Spending

WESTBOROUGH, MA--(Marketwire - November 3, 2009) - Clinical research sponsors now have a faster, more cost-effective and comprehensive technology solution to manage their clinical trial data with PharmaVigilant, a clinical trial technology provider. PharmaVigilant is demystifying the clinical trial process by offering sponsors complete visibility and access into the collection and management of their clinical trial data.

Historically, clinical trial data collection and management are the costliest factors for pharmaceutical sponsors looking to bring new drugs to market safely and effectively. Additionally, having access to, and control of, clinical trial data can either be one of the most common hindrances or greatest advantages to getting a drug through the rigorous FDA approval process. With the emergence of PharmaVigilant, pharmaceutical sponsors now have greater access and control of their data, enabling them to isolate inefficiencies, achieve significant cost savings and increase time to market for their products.

According to Cathy Radovich, Director of Clinical Operations, QuatRx Pharmaceuticals, "When we set out to identify the best possible technology solution for our Phase II and III studies, we looked at several providers in the space and carefully evaluated our options. It came down to who we felt would be the best partner, with the most cost-effective solution for our needs. Working with PharmaVigilant has offered us far greater flexibility and creativity with our data than we've ever had before. Their data-on-demand feature allows us to customize reports at the click of a mouse without incurring any additional fees and the sites have raved about how fast and intuitive the user interface is. I see this as a long-term partnership that will carry us through the many phases of our work."

"Our solution was designed to give sponsors direct visibility into the process behind building their clinical study and delivering their trial data so that any inefficiencies and wasteful costs have no place to hide," said James DeSanti, Founder and Chief Executive Officer, PharmaVigilant. "Our hope is to disrupt the status quo of clinical trials and introduce a new way of doing things. Our cost-benefit to sponsors goes well beyond access to data -- we cut the time on site by almost 50 percent with our remote monitoring solution, resulting in substantial savings, and by utilizing our suite of products we help sponsors significantly eliminate bottlenecks and delays at all levels. With PharmaVigilant I am excited to be in a unique position to bring to market a solution that can truly shift the way sponsors have traditionally approached their technology partnerships."

PharmaVigilant offers a full suite of clinical trial technology offerings, including:

  • InSpire: Electronic Data Capture (EDC) system brings together best-in-class technologies to address the needs of both the industry and the end-users.
  • I-Warehouse: The industry's first commercially available data warehouse, providing analytics across multiple trials.
  • I-Vault eTMF: Electronic Trial Master File System (eTMF) 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 resulting in significant time and cost savings.
  • Inspire Control Center (ICC): A powerful study administration tool that simplifies 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: Improves site relations and satisfaction with easy automated site payment offering detailed reporting and reducing the time it takes for sites to receive payment.

PharmaVigilant's leadership team has extensive experience in the pharmaceutical and software industry. They have worked with more than 400 clinical trials and have been involved in nine clinical technology transfers in the pharmaceutical, biotechnology and medical device industries. PharmaVigilant focuses on Phase I-IV clinical trials, registries and other post-marketing studies and PharmaVigilant's InSpire solution supports more than 200,000 patients in 14 countries across North America, Europe, Asia and Australia and is continuing to expand rapidly.

About PharmaVigilant:

Based in Westborough, Mass., PharmaVigilant is a technology company founded in 2006 to demystify the clinical trial process for biopharmaceutical companies. Its full suite of patient-based technology automates the collection and management of clinical trial data and most importantly puts that data in the sponsors' hands when and how they want it. Sponsors rely on PharmaVigilant to ease the regulatory and FDA submission and approval process and ultimately go-to-market more quickly with top quality drugs. For more information, visit