Products

Study Site Training Series (2018): Volume 1: The Clinical Study Site Team: Roles and Responsibilities

Study Site Training Series (2018): Volume 2: FDA Clinical Research Regulations and GCPs: The Essentials

Study Site Training Series (2018): Volume 3: IRBs/IECs and Informed Consent: Protecting the Rights of Human Subjects

Study Site Training Series (2018): Volume 4: Sponsor Visits and Regulatory Audits: What You Need to Know

Study Site Training Series (2018): Volume 5: Your Role in Reporting Adverse Experiences

Study Site Training Series (2018): Volume 6: Understanding, Evaluating, and Implementing Clinical Protocols

Subject Recruitment: Proactive Project Plans and Issues Management

Technology Innovation and Intellectual Property (IP) in the Biomedical Industry

The Clinical Research Finance Roadmap Companion Reference Guide: Tools, Templates and Resources (Electronic)

The Clinical Research Finance Roadmap: A Comprehensive Guide to the Financial Aspects of Clinical Research

The CRA Role in Risk-Based Monitoring: Strategies for Effective Remote Monitoring

The Form FDA 1572: A Reference Guide for Clinical Researchers, Sponsors, and Monitors

The Fundamentals of Clinical Research Project Management

The IND in a CTD/eCTD Format

Training Portal Subscription

Understanding ICH E6(R3) (GCP) Updates: Key Changes from R2

Use of Notes to File in Clinical Trial Essential Documentation

Utilization of Real-World Evidence (RWE) and Real-World Data (RWD) and Regulations

Working with Clinical Research Sites: Strategic Planning and Operations for Sponsors and CROs

WORKSHOP: Trial Master Files: Why They Are Important and How to Organize Them

Writing and Updating the Investigator's Brochure

Writing Pharmacology Sections of an IND Application

Writing the Clinical Study Protocol