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Videos
About
3:06
Essential Documentation in Clinical Trials at Research Sites
3:19
Clinical Trial Start-Up: Using a Work Breakdown Structure (WBS) for Effective Planning
1:49
Building QbD and RBQM Systems into Clinical Operations
3:44
Inspection Readiness: Understanding BIMO Inspection Req for Sponsors, CROs, Monitor, Investigators
4:09
ICH E8 (R1): Designing Quality into Clinical Studies
2:18
Trial Master File (TMF) for Sponsors: Set Up and Maintenance
2:03
Approaches to Address Challenges in Vendor Management
2:09
Corrective Action Plans: Essential Documentation of a Site’s Response to GCP Deficiencies
5:07
Managing Phase I Clinical Trials
3:00
CRO Partner Management
4:30
Overseeing Teams and Projects
2:17
Introduction to Statistics for Non-Statisticians
2:29
ICH GCP E6 R2 and R3 Updates Implementing Risk Management Approaches for Compliance
5:01
Good Clinical Practice: A Question & Answer Reference Guide 2024/2025
2:37:33
Introduction to Statistics for Non Statisticians
3:45
ICH E6 (R3) and ICH E8 (R1)Updates: Impact on Sponsors
6:46
FDA’s Bioresearch Monitoring (BIMO) Program: Inspection of Sponsors, CROs, and Monitors
7:26
ICH GCP E6 R2 and R3 Updates: Implementing Risk Management Approaches for Compliance
6:49
ICH E6 (R3) and ICH E8 (R1) Updates: Impact on Sponsors
6:55
Developing Clinical Study Budgets for Sponsors
7:03
Risk-Based Monitoring & Quality Mgmt of Clinical Trials: Recent Guidance Updates from FDA & EMA
6:58
ClinicalTrials.Gov Requirements
7:05
Electronic Medical Records: Approaches for Ensuring Source Document & 21 CFR Part 11 Req. Components
7:19
Investigator Initiated Trials: Roles and Responsibilities
6:01
Electronic Informed Consent Guidance: Regulatory Updates
6:15
Ensuring Success Through Smarter Site Selection and Study Feasibility
6:01
Strategies for Managing Difficult Clinical Research Sites
6:27
TMF/eTMF Audit Strategies
6:13
Trial Master File (TMF) for Sponsors: Set Up and Maintenance
7:06
ICH E8 (R1): Changes Impacting Sponsors/CROs
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