Study Start-Up 2021 - Moving Beyond 10 Steps to Clinical Study Startup
Date2021-11-30
Deadline2021-11-23
VenueLIVE WEBINAR, Canada
KeywordsICH E6; Clinical Operations; Study Start-Up
Topics/Call fo Papers
Who Should Attend?
Sponsor and CRO roles who are responsible for:
Country and site identification, feasibility assessment, selection, and activation
Clinical data management, collecting and evaluating trial metrics
Project management of studies, process optimization, and operational excellence
What You Will Learn
In this webinar, featured speakers will explore:
Understanding the operationalization of ICH E6(R1)
The limitations of only 10 steps in multi-site and multi-country trials
Why the 10 steps will not solve the current $2.9B problem or align with ICH E6(R3) efficiency objectives
The benefits of proactive upfront planning in the clinical development plan prior to financially approving the protocol
How new techniques and technology (e.g., quality by design, parallelization, machine learning, etc.) can help improve the operational efficiencies of study startup
Sponsor and CRO roles who are responsible for:
Country and site identification, feasibility assessment, selection, and activation
Clinical data management, collecting and evaluating trial metrics
Project management of studies, process optimization, and operational excellence
What You Will Learn
In this webinar, featured speakers will explore:
Understanding the operationalization of ICH E6(R1)
The limitations of only 10 steps in multi-site and multi-country trials
Why the 10 steps will not solve the current $2.9B problem or align with ICH E6(R3) efficiency objectives
The benefits of proactive upfront planning in the clinical development plan prior to financially approving the protocol
How new techniques and technology (e.g., quality by design, parallelization, machine learning, etc.) can help improve the operational efficiencies of study startup
Other CFPs
- Future of Real-World Evidence: Common Data Models and OHDSI Tools Used in the COVID-Real Case Study
- What is the Link Between Pharmacovigilance and Building Confidence Around COVID-19 Vaccines?
- What is the Link Between Pharmacovigilance and Building Confidence Around COVID-19 Vaccines?
- Utilising a Virtual Central Laboratory Approach to Balance the Delivery, Budget and Risk for Clinical Trials
- Whole-Body MRI Composite Scoring in Neuromuscular Disease Research & Muscle Health
Last modified: 2021-11-18 05:13:25