Global life sciences information analytics provider Elsevier announced a collaboration with Novartis to develop a safety margin risk assessment prediction tool, largely using Elsevier’s PharmaPendium data. The data, which includes searchable FDA and EMA drug approval documentation and packages (including Adverse Events Reports and FDA Advisory Committee meetings), and comparative drug safety, pharmacokinetic, efficacy, and metabolizing enzyme and transporter data, will be used to predict and better justify earlier in the process target selections for development related to human safety, interpretation of clinical significance, and early submission to monitor and mitigate safety risks throughout clinical drug development.
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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.