EU Clinical Trial Regulation (EU-CTR) Requirements

EU Guideline on Computerised Systems and Electronic Data in Clinical Trials

Expediting Drug & Biologics Development: A Strategic Approach 2021

FDA Drug Approval Process

FDA Medical Device Approval Process

FDA Requirements for Electronic Source Data in Clinical Investigations

FDA's Draft Guidance on Ethical Considerations for Clinical Investigations of Medical Products Involving Children

FDA's February 2025 Guidance Update: Key Changes for IRBs and Clinical Investigators

FDA's February 2025 Guidance Update: Key Changes for IRBs and Clinical Investigators

FDA's Updated Informed Consent Guidance: WhatEEs New?

FDAEEs Bioresearch Monitoring (BIMO) Program: Inspection of Sponsors, CROs, and Monitors

FDAEEs Draft Guidance on Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice

FDAEEs Draft Guidance on Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice

Fundamentals of Good Clinical Practice (ICH E6 R2)

GCP Renovation (ICH E8(R1) and ICH E6(R3))

GCP Renovation (ICH E8(R1) and ICH E6(R3))

Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 and ISO 14155

Good Clinical Practice for Investigators

Good Clinical Practice for Sponsors & CROs (ICH E6 R2)

Good Clinical Practice for Study Coordinators

Good Clinical Practice: A Question & Answer Reference Guide 2020/2021

Good Clinical Practice: A Question & Answer Reference Guide 2020/2021 (Electronic)

Good Clinical Practice: A Question & Answer Reference Guide 2024/2025