Randomization and trial supply management (RTSM) and electronic data capture (EDC) technologies and systems are essential to managing clinical trials. As clinical trials become increasingly complex, biostatisticians become even more essential, providing the needed insight to understand protocol-specific randomization nuances and make optimal randomization decisions to improve trial outcomes. In this case study-focused webinar, the featured speakers will highlight how biostatistics is crucial at multiple stages of clinical trials such as study design, randomization implementation, rerandomization needs, randomization and drug supply checks, unblinding and final analysis.
Register to learn about the added value of biostatistics in randomization and trial supply management system solutions for clinical trials.
Paul Vanbosterhaut, Sr. RTSM System Specialist, IDDI
Paul Vanbosterhaut is the Senior RTSM System Specialist at IDDI, a therapy-focused expert clinical data services and high-level strategic consulting contract research organization committed to increasing efficiency and mitigating risks throughout the drug development process. He is an expert in clinical data from trial design to data submission and is dedicated to maximizing business results. Paul is passionate about technology and innovation as evident in his ability to understand and synthesize customer needs. Prior to his role at IDDI, Paul was the Trade Commissioner at the Embassy of Canada and also held roles at Vircom Europe, SA and RealScale Technologies. Paul holds a master’s degree of science in Mathematics.
Anthony Warren, Director, Technical Product Management, Clario
Tony Warren is the Product Owner of the Clario IRT and Trial Supply Optimization (TSO) software solutions. Tony became involved in IRT during the days of phone-base (IVR) systems at a CRO (Kendle International) back in January 2000. Tony led the growth of this product and its transition to a hybrid (phone & web) system as well as the development of advanced algorithms for dynamic minimization and clinical supply management. In 2018, Tony joined OmniComm (later Anju Software) and launched their new IRT product line. Tony joined Clario in 2021 and has led the expansion of the Clario IRT system to support Direct to Patient, program trials, clinical supply forecasting optimization and more advanced dynamic minimization algorithms.
Who Should Attend?
Professionals involved in design, management, analysis and regulatory aspects of confirmatory clinical trials in the pharmaceutical, biotechnology and medical device industries.
What You Will Learn
Through three real-life case studies, attendees will learn:
- How combined advanced biostatistics and innovative integrated randomization and trial supply management system (RTSM) solutions can increase efficiency and mitigate risks throughout the drug development process
- How complex studies benefit from close collaboration between biostatistics experts and RTSM specialists at study design, study set-up (including trial supply optimization) and managing mid-study changes
Clario delivers the leading endpoint technology solutions for clinical trials. Through experience gained from over 19,000 clinical trials delivered in support of 870 regulatory approvals, Clario fuses scientific expertise and global scale into the broadest endpoint technology platform to enable pharmaceutical, biotech and medical device partners to transform lives. Through Trial Anywhere™, Clario has mastered the ability to generate rich evidence across all trial models: decentralized, hybrid and site-based clinical trials. With 30 facilities in nine countries across North America, Europe and Asia Pacific, Clario’s global team of science, technology and operational experts has been delivering the richest clinical evidence for nearly 50 years.