KAI Chooses OpenClinica Enterprise for Phase I–IV Clinical Trials
OpenClinica, LLC has announced that Rockville, MD-based KAI Research, Inc., (KAI), an Altarum Company, has selected the OpenClinica Enterprise Edition to power Phase I – IV clinical trials. Founded in 1986, KAI is a full service contract research organization (CRO) that provides innovative, cost-effective, and practical support to pharmaceutical, biotech and academic institutions, and the National Institutes of Health (NIH).
The OpenClinica software enhances clinical trials by streamlining electronic data capture (EDC) and clinical data management. The result is higher quality and faster access to the data.
“KAI is a CRO that relies on cutting edge information technology to help deliver the greatest value to our clients,” states Patti Shugarts, chief operating officer at KAI. She continues: “OpenClinica’s powerful technology and flexible model enable us to deploy a cutting edge EDC that meets the needs of both our industry and government clients.”
The OpenClinica clinical trial software is provided under a commercial open source model, and available in two editions. The OpenClinica Community Edition software is freely available under a widely accepted open source license. The OpenClinica Enterprise Edition consists of a fully validated version of the open source technology with additional capabilities, services, and resource ideal for mission critical research and highly regulated environments. The OpenClinica software is currently in use at over 500 biopharma sponsors, CROs, academic centers, and government agencies worldwide.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
FDA-Approved Gene Therapy Beqvez Shows Sustained Efficacy, Safety in Long-Term Hemophilia B Trial
April 17th 2025Beqvez (fidanacogene elaparvovec), an FDA-approved one-time gene therapy for hemophilia B, demonstrated sustained factor IX expression, low bleeding rates, and a favorable safety profile over long-term follow-up.
