Pharmanet

Study:	A Phase II, double-blind, placebo-controlled trial to evaluate the safety and efficacy of a novel compound in subjects with diabetic polyneuropathy. More than 180 subjects were enrolled at 30 US sites.

Services Provided:	Full services, including: project management, clinical monitoring, site management, vendor management, medical monitoring, pharmacovigilance, data management, regulatory review, and medical writing.

Challenges:	High rates of pre-screen and screen failure caused by tight criteria for inclusion and exclusion. In addition, 20 sites were capable of using electronic data capture, but 10 sites were limited to traditional paper methods.

Solutions:	The PharmaNet Neuroscience team worked closely with the PharmaNet Clinical Recruitment Group to implement fast, efficient processes for pre-screening and screening. The team also implemented PharmaSoft,® a complete, integral solution for capturing, verifying, and managing the data associated with clinical trials. PharmaSoft provides true hybrid data capture by collecting input from multiple sources, including single-data entry, double-data entry, direct input over the Internet, faxed CRFs, telephoned responses, and scanned, paper CRFs.

Outcome:	More than 450 subjects were pre-screened or screened in a very short timeframe. 187 subjects were enrolled in 74 days. Study data were collected quickly and efficiently from both electronic and paper sources. This client was extremely pleased with PharmaNet’s performance across all departments. The study was completed in record time.