Products

Recent Trends in Noncompliance: Critical Review and Analysis of Recent Regulatory Letters and Communications from the FDA, EMA, and Health Canada

RECIST 1.0 and 1.1: Overview and Data Challenges in Oncology Clinical Trials

Regulatory Intelligence

Risk-Based Auditing: Effective Compliance Strategies

Risk-Based Monitoring and Quality Management of Clinical Trials: Recent Guidance Updates from the FDA and EMA

Risk-Based Quality and Compliance Management in Combination Product Trials

Risk-Based Site Monitoring

Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) in Site Management

Service Provider Oversight: Practical Tools for Clinical Operations Teams

Source Documentation: What is Adequate & Accurate?

Source Documentation: What is Adequate & Accurate?

Sponsor Management of Investigator Non-Compliance

Sponsor Responsibilities for Global Drug Studies

State by State Clinical Trial Requirements (Print)

State-by-State Clinical Trial Requirements Reference Guide 2012 (electronic)

Statistical Concepts for Non-Statisticians

Statistical Intuition for Clinical Research Data Managers

Strategies for Active Listening

Strategies for Assessing Risk Tolerance

Strategies for Effective Remote Monitoring

Strategies for Having Difficult Conversations

Strategies for Managing Difficult Clinical Research Sites

Strategies for Remote Auditing of Investigative Sites