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Navigating FDA’s Draft Guidance on AI in Drug Development: What It Means for Clinical Research
February 4, 2025
The FDA’s latest draft guidance on artificial intelligence (AI) is setting the stage for how AI can be used to support regulatory decision-making in drug and biological product development. This is a …
ICH E6(R3) Is Finalized! What’s Different from the Draft Guidance?
January 16, 2025
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has finalized the much-anticipated E6(R3) guideline on Good Clinical Practice (GCP). …
ICH Releases Draft Annex 2 for GCP E6(R3): Public Consultation Now Open
November 25, 2024
The International Council for Harmonisation (ICH) has taken another significant step toward modernizing Good Clinical Practice (GCP) guidelines with the release of the draft Annex 2 to GCP E6(R3). …
Understanding the New 2024 Declaration of Helsinki: Key Updates for Clinical Research
October 30, 2024
The World Medical Association (WMA) has recently unveiled a significant revision to the Declaration of Helsinki, a cornerstone document guiding the ethical principles of medical research involving …
Strategic Planning for Clinical Research Enterprises
October 22, 2024
Why Your Clinical Research Organization Needs a Strategic Plan In the evolving world of clinical research, developing or updating a strategic plan is essential for keeping pace with industry …
Overview of ICH GCP E6 R3: Key Changes and What They Mean for Clinical Trials
September 14, 2024
Overview of ICH GCP E6 R3: Key Changes and What They Mean for Clinical Trials The release of ICH GCP E6R3 marks a significant update to the Good Clinical Practice (GCP) guidelines, reflecting the …
WHO’s Global Guidance for Best Practices in Clinical Trials- Coming September 2024
September 13, 2024
WHO’s Global Guidance for Best Practices in Clinical Trials In May 2022, the World Health Assembly (WHA) passed Resolution WHA75.8, aiming to improve the quality, coordination, and reliability …
Good Clinical Practice (GCP) E6 R3 Development, Release Date and Adoption
August 24, 2024
The International Council for Harmonization (ICH) proposed the updated to GCP from E6R2 to E6R3 back in June 2019. Fast forward to today as we are approaching the implementation of E6R3 sometime in …
Managing the CRO Through the Clinical Development Journey
May 30, 2024
Managing the CRO Through the Clinical Development Journey Monitoring a Contract Research Organization’s (CRO) performance throughout the life of a clinical trial is crucial to ensure that the …
Understanding the CRO Selection & Management Process
May 3, 2024
Understanding the CRO Selection & Management Process Small emerging biopharma companies typically choose a contract research organization (CRO) based on several key factors, including expertise, …
Do I need a contract research organization or can we do this on our own?
May 2, 2024
Do I need a contract research organization or can we do this on our own? Hiring a contract research organization (CRO) to execute on your clinical studies / program can be a daunting task. Finding …
How do I get started? A Crash course on bringing new therapies to market
May 1, 2024
How do I get started? A Crash course on bringing new therapies to market Starting a pharmaceutical company and bringing a drug to market is a complex process that requires significant expertise, …
A Critical Look at Inclusion & Exclusion Criteria
September 10, 2018
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Developing a Training Program at your Institution- The 7A Model
June 6, 2018
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Expanding Technology in Clinical Trials Fosters Process Improvement
April 9, 2018
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FDA Common Rule- A Much Needed Update
March 22, 2018
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FDA Releases GCP E6 R2 Guidance
March 22, 2018
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Clinical Research Conferences 2018
January 18, 2018
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Quality Management in Good Clinical Practice (GCP) E6 R2 Update
April 2, 2017
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Investigator Oversight: Changes in Good Clinical Practice November 2016 Update
March 28, 2017
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