Practical Considerations for Clinical Trial Sites using Electronic Health Records Certified for Clinical Research
The EHRCR Project released a paper to address regulatory considerations regarding clinical trial sites using electronic health records. This is the first paper of its kind, speaking directly to clinical research investigative sites regarding the use of electronic health record systems. It is based on clinical research regulations and guidances and includes a checklist for sites to assess how their systems (whether certified or not), and their processes comply.
The EHRCR Project is comprised of members from pharmaceutical sponsors, CROs, software vendors (both CR and EHR), and has included regulatory review. They have produced an EHRCR Functional Profile which is now an ANSI/HL7 standard, approved by EuroRec, and is currently under consideration to become a CEN/ISO standard. The profile (a) is founded on current clinical research regulations / guidances, (b) translates requirements into measurable criteria to assess suitability of a system for clinical research, and (c) was used as a input for the recently released CCHIT Certified® 2011 Clinical Research certification option for Ambulatory EHRs. For more information on the EHRCR Project: www.ehrcr.org.
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.
