
Web Seminar Recordings on Key Clinical Research Topics
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Archive: Medical Writing Fundamentals: How to Write Regulatory Documents -
Archive: Overseeing Teams and Projects -
Archive: ICH E8 (R1): Designing Quality into Clinical Studies -
Archive: Managing Phase I Clinical Trials -
Archive: Building Quality by Design (QbD) and Risk-Based Quality Management (RBQM) Systems into Clinical Operations -
Archive: ICH GCP E6 R2 and R3 Updates: Implementing Risk Management Approaches for Compliance -
Archive: Approaches to Address Challenges in Vendor Management -
Archive: Corrective Action Plans: Essential Documentation of a Site's Response -
Archive: CRO Partnership Management -
Archive: Introduction to Statistics for Non-Statisticians -
Archive: Clinical Trial Start-Up: Using a Work Breakdown Structure (WBS) for Effective Planning -
Archive: FDA's Bioresearch Monitoring (BIMO) Program: Inspection of Sponsors, CROs, and Monitors -
Archive: ClinicalTrials.Gov Requirements: Clinical Trial Registration and Trial Results Reporting, Expanded Registry and Results Data Bank -
Archive: Risk-Based Monitoring and Quality Management of Clinical Trials: Recent Guidance Updates from the FDA and EMA -
Archive: Developing Clinical Study Budgets for Sponsors -
Archive: Electronic Medical Records: Approaches for Ensuring Source Document and 21 CFR Part 11 Required Components -
Archive: Ensuring Success Through Smarter Site Selection and Study Feasibility -
Archive: Electronic Informed Consent Guidance: Regulatory Updates -
Archive: TMF/eTMF Audit Strategies -
Archive: TMF/eTMF Regulatory Agency Expectations, Inspections, and Findings -
Archive: ICH E8 (R1): Changes Impacting Sponsors/CROs -
Archive: Investigator Initiated Trials: Roles and Responsibilities -
Archive: State Laws Governing Clinical Trial Regulatory Compliance -
Archive: Minimizing Risk in Negotiating Clinical Trial Contracts and Budgets