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Building Customer Experiences That Lead to More Hope for Patients

Clinical research gives people hope. For some, it’s the chance to hold a new grandchild. For others, it’s walking a

A digital interface showing a person interacting with transparent virtual icons related to compliance, such as "Policies," "Regulations," "Audit," "Guideline," "Requirement," and "Law." The word "COMPLIANCE" is prominently displayed in the center, surrounded by hexagonal icons representing various regulatory and legal concepts.

The Impact of ICH E6(R3) on U.S. and Canadian IRBs

Now that FDA has published the ICH E6(R3) Good Clinical Practice (GCP) guidance, aligning early with these requirements can prepare organizations for the future. ICH E6(R3) encourages ethics review committees to more intelligently apply their resources by enhancing efficiency without compromising participant safety or data integrity particularly regarding continuing review, informed consent, decentralized logistics, and data governance. Sponsors partnering with Advarra can be confident that their studies remain regulation-ready on both sides of the border today and E6(R3)-ready for tomorrow.

CDA Template

This white paper examines four KPIs most impacting timelines and budgets and offers strategies for effective communication and risk mitigation.

Privacy Policy

Overview Advarra, Inc., doing business as Advarra®, and any of our subsidiaries or affiliates (collectively, “Advarra”), provide this policy so

Advarra’s Perspective on FDA’s Draft AI Guidance: Advancing Responsible Innovation

The U.S. Food and Drug Administration’s (FDA’s) recent draft guidance, “Considerations for the Use of Artificial Intelligence to Support Regulatory

The Story Behind Braid: How the Brand Reflects Advarra’s Vision for Data and AI in Clinical Research

Advarra partnered with PreHealth, a brand growth and experience agency, to create Braid, the identity for Advarra’s data and AI

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Are you prepared for ICH E6 (R3)?

The third revision (R3) of the ICH E6 Guideline for Good Clinical Practice represents a significant modernization of global clinical research standards. Research organizations must critically evaluate both their clinical priorities and operational procedures to ensure compliance.

The Executive Order that Brings Private Bioresearch Under Federal Oversight

The release of ICH E6(R3) in January 2025 marks the most significant evolution in Good Clinical Practice (GCP) guidelines in over a decade. More than a revision, E6(R3) marks a shift from traditional practices—making participant safety and data reliability not just priorities, but design drivers, and introducing risk-based proportionality as a foundational approach.

Building Customer Experiences That Lead to More Hope for Patients

The Impact of ICH E6(R3) on U.S. and Canadian IRBs

Privacy Policy

The Story Behind Braid: How the Brand Reflects Advarra’s Vision for Data and AI in Clinical Research

Are you prepared for ICH E6 (R3)?

The Executive Order that Brings Private Bioresearch Under Federal Oversight

ICH E6(R3) Implementation Starts Now: Are You Ready?

Q&A with Advarra’s new Senior Vice President, FDA Regulatory Advisor, Jan Hewett

The Value of Clinical Research