PharmaVigilant, a provider of clinical research solutions, has launched an electronic data capture database for a Phase I/II oncology study in four 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 chemotherapeutic agents gemcitabine, docetaxel or pemetrexed.

The Phase I/II 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 its trial without adding additional resources, PharmaVigilant said.

Stew Kroll, vice president of biostatistics and clinical operations at Threshold, said: "We are impressed with the timeframe PharmaVigilant was able to launch the electronic data capture 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."