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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).

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WMA Adopts 2024 Revision of the Declaration of ...

03/24/2025

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In October 2024, the World Medical Association (WMA) announced the adoption of the 2024 revision of the Declaration of Helsinki (DoH) during the 75th WMA General Assembly in Helsinki, Finland, the same location where the Declaration was initially adopted 60 years prior.

WMA Adopts 2024 Revision of the Declaration of Helsinki
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IRB Warning Letter from BIMO Inspection

03/10/2025

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On September 27, 2024, the US Food and Drug Administration (FDA) issued a warning letter to an Institutional Review Board (IRB) as a result of a (BIMO) inspection from July of 2023. BIMO inspections evaluate compliance with of FDA regulatory requirements, in this case, title 21 CFR Parts 50, protection of human subject, and 56, Intuitional Review Boards.

IRB Warning Letter from BIMO Inspection

Visit Clinical Pathways, LLC.com to Hear Our Interview with MCC’s Executive Director Linda Sullivan

3/23/2021

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Metrics Champion Consortium (MCC) has partnered with Clinical Pathways LLC to expand their eLearning courses on performance management and good clinical practice (GCP). This expansion will add 13 new eLearning courses to their program with more in development.

We sat down with Linda Sullivan, the Executive Director of the WCG - Metrics Champion Consortium (MCC), an industry consortium dedicated to bringing clinical research sponsors, vendors, and investigative sites together to collaboratively develop standardized performance.

Draft GDPR Adequacy Decision for UK

3/02/2021

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When the Brexit transition period ended at the end of 2020, the United Kingdom (UK) officially left the European Union (EU) single market and customs union. This means that for the purposes of the General Data Protection Regulation (Regulation (EU) 2016/679 or GDPR), the UK is a third country with regards to data transfer. As a third country, personal data transfers require additional safeguards. At the beginning of 2021, the EU-UK Trade and Cooperation Agreement came into effect. A part of this Agreement includes a provision which allows data transfers to continue without additional mechanisms until an adequacy decision is adopted, for a maximum of six months.

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:

Is Your Study High Quality? Investigator Warning Letter Issued

2/16/2021

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During the pandemic, onsite FDA inspections were temporarily suspended starting in March 2020 and restarted late summer. Our blog “FDA Resumes Domestic Inspections” describes the risk-based approach to remote assessments during that time period. This in part explains the long interval since the last warning letter. The first new warning letter after inspections resumed was issued to an investigator.