invivodata Granted Patent on Patient Compliance System

June 21, 2005

Applied Clinical Trials

Key Functionality Drives Data Precision in Patient-Reported Outcomes-Based Research

PITTSBURGH -- June 21, 2005 -- invivodata inc., the industry leader in electronic patient-reported outcomes (ePRO) solutions for global clinical research, today announced that the U.S. Patent and Trademark Office has issued patent No. 6,879,970 to the company. This patent covers management of subject compliance in clinical research.

"We are very pleased to be issued this patent," said Saul Shiffman, Ph.D., co-founder and chief science officer at invivodata and one of the inventors of this intellectual property. "We first began using electronic diaries (eDiaries) in our research in 1987 as an outgrowth of our behavioral science research. By applying our unique scientific methods and software algorithms, we have been able to identify ways to deliver unmatched patient compliance in clinical research."

Patient compliance plays a critical role in the success of clinical trials. By using DiaryPRO, invivodata's electronic patient diary, which is based on these patented compliance-enhancing methods, clinical trial sponsors can capture important PRO data from patients at the point of their experience. This approach to capturing real-time data has been proved to significantly improve trial sensitivity, yielding a more accurate measurement of treatment effect.

invivodata intends to work closely and professionally with other suppliers that may desire to include this innovative functionality in their products. Initial contacts have already been made with the key eDiary providers. "We will initiate and support an open dialogue with other eDiary providers that may want to include patient compliance features in their solutions," said Doug Engfer, president and CEO of invivodata. "This constructive dialogue is essential to ensure that the drug-development community has access to the best possible research tools, while protecting our innovative and valuable intellectual property."

About invivodata inc.
invivodata (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 (PRO) 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, which includes DiaryPRO for real-time PRO data collection and SitePRO for site-based PRO data collection, provides access to study data, giving researchers and sponsors visibility into study progress and improving trial efficiencies. invivodata's solution has been used in more than 100 trials involving over 35,000 patients. It has also collected nearly 50 million patient-initiated records, and is the only eDiary system that has delivered the primary efficacy data for FDA drug approvals. 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.