Phlexglobal Announces Availability of New eTMF AI
Phlexglobal has announced the general availability of PhlexTMF v21: an eTMF solution with artificial intelligence. Organizations can utilize PhlexTMF v21 to reduce TMF document misfiles and metadata errors—improving TMF quality, completeness, and timeliness.
PhlexTMF v21 immediately enables new as well as experienced document submitters to:
- Improve TMF quality and reduce inspection risk
- Increase the speed and accuracy of document submissions
- Focus on bringing TMF best practices around quality, completeness, and timeliness into the process earlier
Reference
Phlexglobal Announces Industry-First eTMF AI that Reduces Risk of Document Misfiles and Metadata Errors to Improve TMF Quality and Inspection-Readiness. (2023, March 20). Phlexglobal.
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.
