PHT Corporation's Market Leading LogPad(R) and StudyWorksTM ePRO Solutions Used in Sanofi Pasteur's Phase II Study of New Clostridium Difficile Vaccine
BOSTON, Mass. – December 16, 2009 – PHT Corporation announced that Sanofi Pasteur is using PHT’s LogPad® System and StudyWorksTM online portal for a Phase II trial to develop a vaccine against the Clostridium difficile bacterium. PHT is the leading provider of ePRO solutions used in pharmaceutical and biotechnology clinical trials worldwide. Sanofi Pasteur, a world leader in the vaccines industry, is the vaccines division of the sanofi-aventis Group.
Sanofi Pasteur is working with PHT Corporation to collect direct capture patient experience data quickly, safely and accurately at medical centers across the United Kingdom and the United States. Sanofi Pasteur’s phase IIb trial plans to study over 600 people with an acute infection caused by C. difficile. The bacterium spreads through the human intestinal system causing diarrhea, fever, nausea, abdominal pain, and serious intestinal conditions such as colitis, which can result in death.
Vicki Tyler, a Clinical Trial Manager at Sanofi Pasteur’s Massachusetts facility, explained that, unlike with a paper diary, sites and sponsors know they are receiving real-time trial data when using the LogPad. Sanofi Pasteur has used PHT’s ePRO solutions successfully for other trials and expects to achieve specific improvements in the data gathering processes, data quality, patient compliance, and trial process efficiency by using the LogPad instead of paper for this trial.
PHT Vice President of Marketing and Product Management Sheila Rocchio said, “With paper diaries, researchers can only hope that patients remember to complete their diaries. When patients comply, the data are incomplete and often inaccurate. PHT’s LogPad time-stamps all data entries, providing an immediate data advantage over paper. Using ePRO promotes safety and accuracy in studies, enabling sponsors to bring new drugs to market faster and more economically.”
About PHT Corporation
PHT is the world’s leading provider of electronic patient reported outcome (ePRO) solutions for pharmaceutical and biotechnology clinical trials. The proven LogPad® and SitePad® systems deliver the voice of the patient and capture high-quality and time-stamped assessments with minimal respondent burden. Using PHT’s products, trial sponsors are able to run smaller and more conclusive clinical research programs resulting in significant R&D cost savings. Real-time study management through PHT StudyWorks™ features eClinical data integration, standard and custom data summaries for compliance and enrollment, SafetyPRO™ email alerts, and the industry’s premier study archive. Sponsors have successfully used patient experiences captured firsthand by PHT’s products in at least 12 NDA submissions and seven approvals. For more information and interactive product demonstrations visit www.phtcorp.com.
PHT, LogPad, eSense, StudyWorks, SafetyPRO and SitePad are among the registered trademarks and trademarks of PHT Corporation.
Contact: Brenda Nashawaty, bnashawaty@phtcorp.com, 617-688-3253
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