ICH E6(R3) Explained: Key Changes to GCP Guidelines
Explore the updated ICH E6(R3) Good Clinical Practice (GCP) guideline. Learn about the key changes from R2, the new structure with Annex 1 & 2, and risk managem
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Articles tagged with “data-governance”
Veeva OpenData Onboarding: Data Quality Pitfalls & Fixes
A guide to Veeva OpenData onboarding for life sciences. Learn to identify and avoid common data quality pitfalls like duplicates and outdated HCP/HCO records.
What Is a Semantic Layer? A Guide to Unified Data Models
Learn what a semantic layer is. This technical guide explains how it bridges data sources and BI tools, creating unified metrics and business-friendly data mode
A Guide to Automating Veeva Vault Metadata Change Detection
Learn why automating Veeva Vault metadata change detection is vital for life sciences compliance. This guide covers methods to prevent data risks and ensure aud
ICH E6(R3) Explained: A Guide to the 2025 GCP Update
An in-depth analysis of the ICH E6(R3) Good Clinical Practice guidelines for 2025. Explore key changes in Quality by Design, data governance, and decentralized
The Role of WORM Compliance in Biotech Data Integrity
Learn how WORM (Write Once, Read Many) storage ensures data immutability and integrity for electronic records in the highly regulated biotechnology industry.
AI in the Pharmaceutical Sector: An IT Management Guide
An overview of AI applications in the pharmaceutical sector, from generative AI to ML. Explains key IT management challenges like data, compliance, and security.
Integrating ECM Systems: Box, Veeva Vault & Compliance
This article examines strategies for integrating content management systems like Box and Veeva Vault to overcome information silos in regulated environments.
A Guide to a Single Source of Truth for Drug-Lifecycle Data
An explanation of a single source of truth (SSOT) for the pharmaceutical industry. Learn how an SSOT integrates data across the drug lifecycle to ensure consistency.
HCP Data Providers: U.S. Market, Compliance & Best Practices
Overview of major HCP data providers, U.S. compliance rules, and best practices for pharma IT. Includes vendor comparison, legal requirements, and governance tips.
Integrating RTSM Systems with EDC Platforms in Clinical Trials
A comprehensive guide to integrating Randomization and Trial Supply Management (RTSM) systems with Electronic Data Capture (EDC) platforms, covering benefits, challenges, and vendor solutions.
State-of-the-Art Data Warehousing in Life Sciences
A comprehensive guide to modern data warehousing solutions for life sciences organizations, covering cloud vs. on-premise strategies, technology stacks, compliance requirements, and scalable approaches for organizations of all sizes.