Fractional Auditing in Pharmaceutical Quality Assurance
In the increasingly complex landscape of pharmaceutical research and development, maintaining data integrity while balancing resource constraints has become a critical challenge for quality assurance professionals. Fractional auditing has emerged as a strategic methodology that enables organizations to optimize their quality oversight without compromising compliance. This article explores the implementation of fractional auditing approaches.
The Helsinki Declaration 2024 Update: Advancing Ethical Standards in the Era of Digital Clinical Research
The 2024 update offers important clarifications for pharmaceutical sponsors, clinical research organizations (CROs), and biotech innovators navigating the increasingly digital clinical trial landscape. Read more here
The Evolving Landscape of Pharmacovigilance IT: Key Considerations for the EU Regulation Amendment
The European Commission’s draft amendment to Implementing Regulation (EU) No 520/2012 introduces significant updates to pharmacovigilance requirements, with far-reaching implications for IT quality assurance in the pharmaceutical industry. These changes will extend well beyond computer system validation (CSV) to include data governance, data integrity, and comprehensive audit strategies. Full article here
The evolution of IT Quality and Validation in Clinical Trials – Final part
You can find the final instalment of Matt’s mini series here. If you missed part two, click here and part one is here
The evolution of IT Quality and Validation in Clinical Trials Part 2
You can find Part Two of Matt’s paper here. Part Three will be coming soon. If you missed Part One, click here
Advancing Pharmaceutical Protocols: How ICH M11 CeSHarP Transforms Digital Compliance
The pharmaceutical industry is undergoing a significant transformation with the adoption of the International Council for Harmonisation (ICH) M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP) standard. This technical specification, updated in March 2025, represents a pivotal shift in how clinical trial protocols are structured, managed, and exchanged across global regulatory environments. Read more here
The Evolution of IT Quality and Validation in Clinical Trials Part 1
The clinical trial landscape has undergone significant transformation with digital technology becoming increasingly central to trial design, data collection, and management. The recently updated International Council for Harmonisation (ICH) Good Clinical Practice (GCP) E6(R3) guideline, adopted in December 2024 and coming into effect July 2025, represents a major evolution in how regulatory bodies expect sponsors […]