invivodata's Electronic Patient Diary Is Selected To Capture Patient Reported Outcomes Data in Cephalon Sleep Disorder Trials

Business Wire, August 23, 2004

PITTSBURGH -- eDiary Captures Primary Efficacy Data in Four International Clinical Trials

invivodata(R) inc., an industry leader in electronic patient self-report solutions for clinical research, today announced that Cephalon Inc., a West Chester, Penn.-based global biopharmaceutical company, is using DiaryPRO(TM), invivodata's eDiary system, to collect pivotal Patient Reported Outcomes (PRO) data in four Phase III clinical trials of armodafinil. More than 200 clinical sites worldwide, including those in Eastern Europe and the Pacific Rim region, are enrolling more than 1,000 patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder for these trials.

"We conducted a thorough review of electronic diary providers, including those we have worked with in the past," said Dr. Gwendolyn Neibler, senior director of clinical research at Cephalon. "We chose to work with invivodata based on its expertise in optimizing patient compliance and its experience in executing international trials. invivodata's methodologies are already delivering higher rates of patient compliance than we have seen with other electronic diary systems."

Armodafinil is the second compound in Cephalon's wake-promoting franchise. In ongoing trials of armodafinil, patients are using invivodata's eDiaries to record data that will determine the drug's effect on their nighttime sleep and daytime sleepiness.

invivodata combines behavioral and clinical science with handheld and Web technology to deliver real-time PRO data in clinical trials. As a result, sponsors capture PRO data of the highest integrity and benefit from increased study sensitivity and maximized confidence in the trial data.

"We are thrilled to work with Cephalon on these important trials and to add them to our long and growing list of satisfied customers," said Doug Engfer, founder and CEO of invivodata. "We look forward to providing the PRO data that will determine the effectiveness of this novel compound."

About invivodata inc.

invivodata (http://www.invivodata.com) combines behavioral science, information technology and clinical expertise to capture clinical trial data of the highest integrity directly from patients. invivodata's electronic patient reported outcomes system delivers high-quality patient self-reported data by driving patient compliance with the protocol and eliminating recall biases that plague self-report studies. The invivodata solution also provides real-time access to study data, giving researchers and sponsors visibility into study progress and improving trial efficiencies. The invivodata eDiary has been used in over 80 trials involving tens of thousands of patients. It has also collected more than 30 million patient-initiated records, far more than any other electronic diary solution, and is the only eDiary system that has delivered the primary efficacy data for an FDA drug approval. invivodata inc. is a privately held company with global headquarters in Pittsburgh; its primary development center is in Scotts Valley, Calif.; and its European headquarters are in London.