OpenClinica, a Boston-based provider of software for electronically capturing clinical research data, has launched Participate, a mobile, device independent solution for engaging participants in clinical research. Participate broadens possibilities for clinical research, by making it easier to meaningfully engage patients and collect high quality, timely data from patients in a way that is convenient for them.
To date, OpenClinica has produced clinical trial electronic data capture software, widely used by biopharma, medical device, CRO and academic researchers. The addition of Participate adds a friendly and effective way to engage patients directly in those same OpenClinica-powered clinical studies.
"Collecting accurate, timely, useful data directly from patients has been a longstanding challenge for clinical research," said OpenClinica's Alicia Goodwin, who helped design Participate. "Researchers have either relied on antiquated paper diaries or the provisioning of additional devices to patients, both of which are expensive, logistically complex and unreliable. Participate makes it easy to create and send forms directly to study participants in a simple and secure interface on their own smartphone, tablet or PC. With the state of technology today, we believe there is no longer a need to use paper PROs alongside EDC, or engage multiple specialized vendors resulting in siloed data sets and integration complexity."
Using Participate with OpenClinica EDC allows researchers to design participant-facing events, reminders, and assessments alongside clinical visits and CRFs, using OpenClinica's existing, user-friendly study build tools. All the clinical and patient reported outcomes data are seamlessly captured in a single place. As data are submitted by study participants, their activities become part of the same regulatory compliant audit trail that tracks all clinical user activity. The data participants submit, are immediately available for review and analysis alongside CRF data from other sources.
"The difficulty of engaging with study volunteers in a meaningful and timely way is as an obstacle to successful research. We live in a world where 90% of adults have smartphones, 81% text and 63% use their phone to go online. We need to reach patients on their terms, whether email, SMS, web, or a mobile device," said Cal Collins, OpenClinica's CEO. "Treating research volunteers as participants, as opposed to subjects, can lead to concrete benefits, such as improved compliance more effective recruiting, and more complete, timely data. It can even help enable new protocol designs that better target populations and/or more closely align with real-world use. But most of all, it just seems like the right thing to do."