Today’s clinical studies are increasingly complex and require patient-centric trial designs, like decentralized trials, more than ever before. As trials incorporate more decentralized components there is an ever-present need for multiple system integrations to support the various trial functions, with the goal being that all trial data flows seamlessly between systems and is stored in one repository for efficient oversight and analysis. These numerous integrated systems require closely managed integration, synchronization, and supportive partnerships to minimize error and maximize efficiency. In this case study, partners endpoint and THREAD dig-in to explore how IRT can be integrated with decentralized clinical trial (DCT) technology, working through tightly integrated workflows, to provide a streamlined process, a better user experience for Sites and Participants, higher quality data and real-time access to information.
Making the Grade: Registries as Sources of Regulatory-Grade Real-World Evidence (RWE)
February 13th 2025Dr. Peter Wahl, MLA, MS, ScD, VP and Global Head of Scientific Affairs at CorEvitas, part of the PPD™ clinical research business of Thermo Fisher Scientific, discusses the critical role of protocol-driven registries in generating regulatory grade RWE to serve multiple and evolving evidence needs across the drug development life cycle. He covers key considerations for selecting the right type of registry, explains why registry data is the gold standard in RWD, and how it contextualizes safety and effectiveness to fulfill FDA and EMA post-marketing requirements.
Optimizing Phase III Oncology Trial Recruitment with Data-Driven Insights
February 3rd 2025A pharmaceutical company aimed to launch a Phase III clinical trial for a new oncology drug, focusing on efficient and effective patient recruitment across diverse regions. They evaluated patient populations by analyzing demographics, social determinants of health, and geography. Investigator profiling included practice details, affiliations, referral networks, and clinical trial experience. The final step involved selecting and extracting target lists for implementation.
Data-Driven Insights can Optimize Clinical Trial Site Selection
February 3rd 2025Clinical trials are crucial for drug development but often face delays due to poor site selection, which can lead to protocol violations, poor data quality, and increased costs. Ninety percent of clinical trials fail to meet their timelines, and issues like inadequate staffing and patient recruitment are significant challenges. Traditional site selection methods are inefficient, and the COVID-19 pandemic has further complicated the process. Data-driven insights can optimize site selection by evaluating current data on patient populations, investigators, and site capabilities.