Although often not a component of the initial study plan, a contingency plan can be needed if a study is transitioned because of acquisition at the sponsor level, performance/capability issues or study re-design. When addressing this type of transition or “rescue” scenario, it is important to recognize the unique challenges that a study team will face. Because study conduct is already underway, the focus shifts beyond initial study implementation to the entire study process, requiring meticulous planning for simultaneous transition of administration, logistics and technology, as well as project and data management. Effective, efficient transition of study conduct requires consideration of not only the sponsor, CRO and associated service providers but also particularly the study sites, to avoid losing or potentially to regain or energize participating sites.

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Speaker

Kevin Bishop, VP, RTSM, Bioclinica

Kevin Bishop 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, Bishop 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. Bishop has a Bachelor’s degree in Physiology and Pharmacology from the University of Southampton (UK).

Message Presenter

Who Should Attend?

This webinar is suitable for managers, leads and other relevant job titles in the following departments:

Clinical Supply
RTSM
Interactive Response Technology
Clinical Trial
Clinical Operations
Clinical Outsourcing
Clinical Technology
Data Management
Regulatory
Site Management
Clinical Monitoring
CMO, CSO, CIO
TA Head
Medical Monitors
Clinical Scientists
Imaging or Biomarkers Scientists
Heads of: R&D, Clinical Research, Clinical Development, Clinical Operations
Study/Project Manager
Protocol Manager
Study Startup

What You Will Learn

Drawing on experiences of undertaking study rescues and transitions, participants will learn about:

Key considerations and learned lessons when transitioning mid-study
Resource requirements for rapid deployment
The effect of study stage on patient safety and regulatory considerations

Xtalks Partner

Bioclinica

Bioclinica is a global life-science provider that utilizes science and technology to bring clarity to clinical trials – helping companies to develop new, life-improving therapies more efficiently and safely. The company’s offerings include medical imaging and cardiac safety services; clinical adjudication; randomization and trial supply management and optimization; electronic and eSource data capture; site and patient payments and budget forecasting; pharmacovigilance, and trial management.