Interactive Response Technology manages clinical trial randomization and getting the right investigational product (IP) to the right patient at the right time. What happens when trials do not mature as expected? Perhaps enrollment is slow and new regions and sites have to be added. Perhaps new doses and cohorts are added to a protocol. How do you capture these changes into your interactive response technology (IRT) system? How do these changes impact production or clinical supply at the depot. Join this webinar to hear Tony Warren, the director of tech product management at Bioclinica, discuss these types of scenarios and how to best manage them.
Kevin Bishop, VP, Enabled Client Services – Software Solutions, Bioclinica
Kevin is a recognized clinical research senior executive with more than 30 years of operational and business leadership experience, the last 20 years of which have been in the high-growth eClinical technology space. In his current role, Kevin is responsible for driving the growth strategy for the Randomization & Trial Supply Management (RTSM) business, encompassing Bioclinica’s innovative IRT platform, clinical supply forecasting, optimization and planning services, as well as further developing Bioclinica’s unique project delivery methodology. Prior to Bioclinica Kevin led the RTSM and clinical logistics solution business at PAREXEL Informatics. Before that, Kevin was with ClinPhone for ten years focused on RTSM and other eClinical solutions before being acquisition by PAREXEL in 2008. Kevin has lived in the USA since 1999 when he relocated from the United Kingdom to facilitate the establishment of ClinPhone’s business and North American operations. Prior to this he spent approximately ten years managing the execution of clinical development plans for various multinational pharmaceutical companies spanning all stages of pre-clinical and clinical research. Kevin has a Bachelor’s degree in Physiology and Pharmacology from the University of Southampton (UK).
Tony Warren, Director, Tech Product Management, Bioclinica
Tony Warren is Director, Technical Product Management in Bioclinica’s Software Solutions group. He is Product Owner for the Randomization and Trial Supply Management (RTSM) and Trial Supply Optimization (TSO) solutions. Tony has been working in this field since 2000, where he managed an IVRS randomization system and led the evolution of that system to a web-based system supporting not only randomization, but supply management and patient reported outcomes in globally managed trials. He had led the implementation of RTMS in a wide range of therapeutic areas. He is currently managing upgrades to Bioclinca’s RTSM solution for direct to patient drug delivery, continuous supply optimization forecasts (integration with the TSO solution), and enhanced support for Platform (based, umbrella) trials and adaptive trials.
Who Should Attend?
- Chief Medical Officers
- VP/Directors of Clinical Operations
- VP/Directors of Clinical Supplies
What You Will Learn
In this webinar, participants will learn that:
- Configurable IRT systems can better manage and adapt to changing studies
- Trial supply optimization is the best way to simulate changes in studies and their impact to clinical supply
- An integrated system is the best way to manage a study with changes
Bioclinica, an ERT company, is an integrated clinical life science solutions provider, leveraging knowledge and insight to minimize risk and accelerate development in clinical trials. Through deep medical, scientific, and technology expertise, the company provides medical imaging and cardiac safety services, clinical endpoint adjudication, clinical trial software, and drug safety solutions. For more information, visit www.bioclinica.com.
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