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Now Available: Clinical Pathways’ Major Changes ...

05/30/2025

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In the ever changing world of clinical research, staying up to date with the latest guidelines and best practices is crucial. Our Major Changes in GCP from ICH E6(R2) to (R3): Road Map is designed for busy professionals who want to deepen their knowledge on GCP to help ensure they meet the highest standards of quality, safety, and compliance.

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FDA Draft Guidance on Considerations for AI Use

05/21/2025

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In January 2025, the US Food and Drug Administration (FDA) published a draft guidance titled “Considerations for the Use of Artificial Intelligence (AI) to Support Regulatory Decision-Making for Drug and Biological Products” for trial sponsors and stakeholders intending to use AI to generate data and clinical evidence.

FDA Draft Guidance on Considerations for AI Use
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EMA on the use of Real-World Data/Evidence in ...

04/30/2025

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In March, 2025, the European Medicines Agency (EMA) released a “Reflection paper on use of real-world data (RWD) in non-interventional studies (NIS) to generate real-world evidence (RWE) for regulatory purposes” as a guidance for stakeholders on quality planning, conduct and analysis of NISs that intend to use RWD to generate RWE.

EMA on the use of Real-World Data/Evidence in Non-Interventional Studies
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FDA Warning Letter to Sponsor – Records, ...

04/22/2025

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In November 2024, the US Food and Drug Administration (FDA) issued a warning letter to the sponsor as a result of a BioResearch Monitoring Program (BIMO) inspection which observed objectionable conditions. The warning letter cited two violations of the Title 21 CFR.

FDA Warning Letter to Sponsor – Records, Reports, and Audit Trails
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OGPS and FDA discuss FDA’s Role in the DoH ...

04/08/2025

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In December 2024, following the release of the 2024 revision of the Declaration of Helsinki (DoH), US Food and Drug Administration (FDA) staff shared the FDA’s perspective on what their role was in the development of the 2024 DoH and how it may impact FDA procedures. The DoH is intended to guide clinical research involving human participants that is often used as the foundation for other guidelines such as the International Council for Harmonisation (ICH) Good Clinical Practice (GCP).

quality systems

Sam Sather a Speaker and Panelist at SCOPE Virtual Summit for Clinical Ops Executives

2/23/2021

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Topic for Speaking Engagement and Panel Discussion: Central and Remote Monitoring: Leveraging Central and Remote Monitoring in Risk-Based Quality Management

Topic for Panel Discussion: Medical Device Trial Regulations, Quality and Data Management: Navigating a Changing Regulatory Landscape and Accelerating Approvals

Dates: March 2 - 4, 2021

Location: The virtual summit consists of pre-recorded sessions with live panel discussions and live Q&A sessions.

Register: https://register.healthtech.com/reg/scope

Sandra “SAM” Sather is:

Clinical Trial Risk & Performance Management vSummit Sept. 8th - 12th

9/01/2020

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Sandra “SAM” Sather, VP of Clinical Pathways and a 2020 MCC Ambassador, is speaking on the topic “The RBM Training Gap: Risk-Based Monitoring the Noun vs. the Verb”. Have you heard "We are not doing RBM for this study . . ." What? Our quality system should support a risk-based approach to many clinical trial activities like site monitoring, data quality oversight, vendor oversight, safety surveillance, audit planning, and more.

The Future of Risk-Based Monitoring: What We Are Learning During COVID-19 Restrictions

7/07/2020

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Have you ever heard or stated, “We are not doing risk-based monitoring for this study”? This is using the term to refer to a style vs. a process to conduct monitoring based on risk. This means that there was a decision to conduct “traditional” monitoring, with 100 percent source data verification (SDV) and/or 100 percent data review of trial subjects.