A Critical Review of Current Initiatives and Guidelines with Regard to Their Impact on Sponsors Approach to Quality
The session will cover the current and planned changes to GCP (ICH E6 R2 / R3) and associated guidance ICH E8 R1) with their impact on the clinical development...
Bayesian Adaptive Designs for 21st century Clinical Trials
I this webinar your will learn the basic philosophy of Bayesian statistics, why it is not the main-stream method and why it will become more and more popular for...
Vaccine and Clinical Data Management
Participant will be able to find out about the Vaccine in brief, the process of Vaccine Production, their impact on Human life, Vaccine Evolution, Clinical Trials of...
Introduction to Artificial Intelligence in Drug Development (Part 1 and 2)
This webinar is a first step to support our Drug Development community comprehend a key component of our future: AI!
New Research: Patient Data Collection Concerns in Pandemic Environment
The COVID-19 pandemic has - without warning - turned clinical operations on its head, forcing the clinical research industry to re-evaluate how to manage clinical...
Demystifying Decentralized Trials - Best Practices, Pitfalls and What Data Managers Need to Know
It’s hard to not hear about vaccines all over the news, given the current world situation. How are these clinical trials performed? What sort of data do they collect?...
The evolution of the CDM Roles according to the latest SCDM Reflection Paper on our journey towards Clinical Data Science
It’s hard to not hear about vaccines all over the news, given the current world situation. How are these clinical trials performed? What sort of data do they collect?...
Vaccine Clinical Trials – What Data to Collect and How to Review It
It’s hard to not hear about vaccines all over the news, given the current world situation. How are these clinical trials performed? What sort of data do they collect?...
Acceleration of Digitization of Clinical Development post COVID-19
n the midst of the COVID-19 pandemic, more than ever before, BioPharma companies are looking to bring agility, velocity and acceleration to their clinical development...
Data Science: New Approaches for Old (and New) Problems
The purpose of this webinar is to provide interested parties with an overview of the emerging field of Data Science. We will discuss what is meant by the term Data...
Risk-based Computer System Validation; Reduce Costs and Avoid 483 - July 10
This training session describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications....
How To Manage Unique Data Types Within Oncology Trials: Biomarkers, Imaging, Radiotherapy, eCOA
Oncology trials collect unique data types. Attendees of this webinar will get an overview of Oncology data types, the challenges faced during the study design phase...
Embracing Oncology Trials Design: Neo/ Adjuvant, Basket, Umbrella Designs
Definitions of each study design, differences among the study designs, challenges faced during design, data collection and data cleaning. Common themes across the...
What’s the Experiment? (Protocol Review)
Foundational information regarding what constitutes a good clinical study in relation to regulations, and the incorporation of basic scientific and ethical principles...
Data validation – Why, What and How in the context of new technology
Data validation is one of the key activities and critical process to ensure good data quality for a clinical trial. Defining the data validation strategy depends on...