The United States Patent and Trademark Office (USPTO) has granted two additional patents for ERT, a global technology-driven provider of health outcomes services to biopharmaceutical sponsors and contract research organizations (CROs). The US patents No. 8,065,180 and 8,145,519  are titled System for Clinical Trial Subject Compliance and were acquired by ERT as part of the recent acquisition of invivodata.

“We are very pleased to be issued these additional patents,” said Saul Shiffman, PhD., pioneer of the electronic patient reported outcomes industry, invivodata founder and one of the inventors of this intellectual property. Shuffman further added, “It is extremely rewarding to have our processes, which are based on proven scientific principles, be recognized in this manner and to see first-hand the benefits they are delivering to researchers who seek the most reliable and valid patient-centered data possible.”

The patents cover the tracking and enhancement of participant compliance with a research protocol and can also be used to provide evaluability data related to participant performance in a clinical trial. Participant compliance is defined as the degree to which trial participants (patients and study team – including investigative site personnel) meet the expectations of the trial sponsor with regard to using a diary or other reporting mechanism to record answers to questions about their experiences during the trial.

Participant compliance with the research protocol is critical to ensuring the success of clinical trials. ERT's electronic diary solutions - DIARYpro for remote patient data collection, and SITEpro (for site-based data collection) - are built on these patented compliance-enhancing methods and have been repeatedly proven to capture important COA data at the point of the participant's experience, yielding a more accurate measurement of treatment effect.

ERT has launched a tiered licensing programme to enable other industry suppliers to include this innovative functionality in their products. Initial contacts have already been made with the key eDiary providers and several have expressed interest in participating. “We will support an open dialogue with other eDiary providers that may want to include participant compliance enhancing features in their solutions,” said Dr Jeffrey Litwin, CEO of ERT. “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.”

ERT leads the industry in creating and deploying meaningful innovations that advance the collection of effective COA data for clinical research. A sample of these innovations and industry-firsts include: creation of the first handheld patient eDiary, first wireless eDiary solution, first scientific demonstration of significant increases in patient compliance with eDiaries, first new drug approved based on primary efficacy data collected on an eDiary, and the first proven increase in study power due to the integrity of eDiary data.

ERT harnesses leading technology coupled with reliable processes and scientific expertise to collect, analyze, and report on clinical data to support the determination of health outcomes critical to the approval, labeling and reimbursement of pharmaceutical products.