“invivodata was able to deliver us the real-time data that we needed to develop an unbiased view into our patients’ pain experiences. This kind of data cannot be collected with paper diaries.”
Dr. Michael Gendreau
Chief Medical Officer, Cypress Bioscience
MediQuest Therapeutics Selects invivodata’s DiaryPRO
- June 19, 2006
MediQuest Therapeutics Selects invivodata’s DiaryPRO for Use in Second Phase III Trial for Raynaud’s Phenomenon
PITTSBURGH — June 19, 2006 — invivodata™ inc., the industry leader in electronic patient reported outcomes (ePRO) solutions for global clinical research, today announced that MediQuest Therapeutics Inc. has selected DiaryPRO®, invivodata’s handheld electronic patient diary system, for a second Phase III clinical trial of its topical gel formulation of nitroglycerin, MQX-503, for the treatment and prevention of Raynaud’s phenomenon.
MediQuest selected DiaryPRO for this second trial, which is based in Europe, due to the high-quality PRO data invivodata delivered in the earlier, U.S.-based, phase III trial for this indication. Both trials will follow a similar protocol in which adult patients use DiaryPRO to record the frequency and severity of their hand pain. Raynaud’s phenomenon causes patients’ blood vessels to constrict, reducing blood flow to their extremities.
“We chose to continue working with invivodata because of the excellent results it delivered during our first project,” said Dr. Fred Dechow, president and CEO of MediQuest. “Capturing this type of patient information in real time is critical to determining the effectiveness of this gel. We trust invivodata to design an ePRO solution that patients — especially older patients — can easily use to record their treatment assessments as the Raynaud’s attack occurs. That type of data is vital to the success of this program.”
invivodata custom-designed an eDiary system for this study that included an enlarged stylus patients could use to interact with the device even during painful attacks. In this new trial, patients will use the eDiary daily, for up to eight weeks, to record the onset of attacks and details about the timing and the severity of the attacks.
“We are honored to be considered a trusted partner by MediQuest and are delighted to continue our relationship with it on this novel international drug-development program,” said Doug Engfer, president and CEO of invivodata.
About invivodata inc.
invivodata combines behavioral science, information technology and clinical expertise to capture the highest-quality electronic Patient Reported Outcomes (ePRO) data in clinical research. The invivodata solution, which includes DiaryPRO® for real-time PRO data collection and SitePRO® for site-based PRO data collection, is based on patented compliance methods that include a proven patient management system that gives researchers and sponsors visibility into study progress and improves trial efficiencies. Strengthened by its regulatory and scientific expertise, invivodata is the industry-leading eDiary provider for delivering primary efficacy data for FDA approvals. Its solutions have been used in 140 clinical trials worldwide by more than 55,000 patients, collecting over 89 million patient-initiated entries for studies in over 65 disease states. invivodata’s scalable business model enables it to satisfy diverse client needs and meet the increasing global demand for its innovative solutions. invivodata inc. is a privately held company with global headquarters in Pittsburgh, Pa., USA; its European headquarters are in London, England; and its technology development center is in Scotts Valley, Calif., USA.
