PharmaVigilant Launches Electronic Capture Database for Phase 1/2 Oncology Trial in 4 Weeks for Threshold Pharmaceuticals

Business Wire, Nov 12, 2008

WESTBOROUGH, Mass. -- PharmaVigilant announced today they launched an electronic data capture database for a Phase 1/2 oncology study in 4 weeks for Threshold Pharmaceuticals. The clinical trial design includes three separate treatment arms examining escalating doses of TH-302, Threshold's proprietary Hypoxia Activated Prodrug in combination with the following chemotherapeutic agents: Gemcitabine, Docetaxel or Pemetrexed. The Phase 1/2 study database design required the creation of over 50 unique case report forms and six separate CRF books to accommodate the study population. The flexibility built into the database design of this oncology trial will enable Threshold to better manage enrollment and the data collection throughout their trial without adding additional resources.

"We chose PharmaVigilant based upon their track record, positive references, and straight-forward cost structure." said Stew Kroll, Threshold's Vice President of Biostatistics and Clinical Operations. "We are impressed with the timeframe PharmaVigilant was able to launch the EDC system for our trial given the sophisticated database design. The process was seamless from the kick off meeting to launch, and PharmaVigilant stayed on time and on budget, despite some database design changes along the way. The system's safety reporting tool and data warehouse will enable us to perform real-time safety monitoring of our patients and ensure regulatory compliance."

"We were pleased to add Threshold to our family of companies." said James DeSanti, CEO of PharmaVigilant. The solution will provide them with the ability to collect data in real time; minimizing their time to clean and validate their clinical data."

About PharmaVigilant

PharmaVigilant offers unique solutions to address the complexities of global clinical research. The Company focuses on Phase 1-4 clinical trials, registries and other post-marketing studies. The InSpire solution supports over 250,000 patients in 14 countries in North America, Europe, and Asia, and incorporates the latest single platform, modularized EDC technology in the healthcare industry. Other solutions include InSpire, I-Warehouse, I-Vault, InSpire Reporting Tool, InSpire Control Center, I-Builder, and PaySite. For more information, please visit the web site at www.pharmavigilant.com.