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...
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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...
CRF Design for Randomization and Drug Dispensation (Chinese)
Randomization and drug dispensation are key components in clinical trials. The processes usually involve various functions and are sometimes complicated.
Becoming a better LDM, bringing your A-Game
This Webinar will go over the full spectrum of knowledge areas an LDM should have, as well as emphasize the required soft skills to fully represent and assume...
Why and How to Use Global Data Standards
In this webinar we will explore the value of using global, open data standards for clinical research when the data are not intended for a regulatory submission.
Quality By Design And Not By Accident - RBM & Transcelerate
The FDA and EMA guidance documents (2013) that led to the initiation of RBM in clinical trials, have been cemented with the ICH E6 R2 (GCP) update in 2016.
Artificial Intelligence and Clinical Trials: Interventions and Cycles
Examining the various points in a clinical trial life cycle where machine learning can "intervene": from data science, to trial design to patient matching and site...
Lead Data Manager: A Critical Role in any Project or Trial
Do you want to learn or enhance your skills and gain an understanding of the critical tasks managed by the Lead Data Manager (LDM)?
Eeny, Meeny, Miny, Mo - How to Pick that EDC?
This webinar will examine the foundational considerations for selecting an EDC application; identifying the organization’s business needs, implementation timelines,...
Unravelling the mysteries of a Centralized Risk Based UAT Model!
How much UAT is enough? Who performs UAT? Do you have a UAT process in place that is vendor agnostic? How does ICH E6 R2 impact your current UAT process?
Measuring Data Quality—Are all Errors Created Equal?
As Clinical Data Managers we are always conscious that our deliverable-a “clean” analyzable database-is of utmost importance.