Dec 17 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.”
http://www.phtcorp.com/
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