TransCelerate BioPharma has established two new global initiatives in the clinical trials area. Both initiatives - Placebo / Standard of Care Data Sharing and Electronic Labels for Clinical Trials (e-Labels), are made possible through the collaboration of participating Member Companies.
The Placebo / Standard of Care Data Sharing Initiative is to create a framework for data sharing that allows for the leverage of data from previous studies respecting boundaries of informed consent. It offers the potential for more rapid understanding of safety signals to better manage patient safety during clinical trials, as well as identify statistical techniques that may deliver more accurate study design and statistical power calculations. The platform will be provided to Member Company biostatisticians to hopefully lead to improved protocol development, reduction in protocol amendments and a better understanding of disease models to identify the right targets. The goal is to maximize the value from the data generated from a patient participating in a clinical trial, as well as the R&D investment.
The e-Labels Initiative will support TransCelerate Member Companies in establishing an innovative information channel: Electronic Labels (e-Labels). This initiative will work to enhance label utility for patients, provide more consistent labeling approaches for sites and offers the potential to reduce clinical labeling timelines and provides cost efficiencies for sponsors. The Initiative, in collaboration with Regulatory Agencies, will develop guidance to facilitate implementation of e-Labeling.
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.