Feb 10, 2026 The Data Multiplier Effect: When Expertise, Monitoring, Systems, and AI... Clinical research is evolving rapidly. Trials are more complex, data sources keep expanding, and regulators... Learn more
Feb 04, 2026 Outsourcing EDC System Validation: What Sponsors Need to Know For many clinical trial sponsors, validating Electronic Data Capture (EDC) systems internally is a costly,... Learn more
Jan 30, 2026 Digitizing Clinical Software Validation: Why Sponsors Can’t Afford to Stay... For years, sponsors have relied on paper binders, Excel spreadsheets, and PDF checklists to... Learn more
Jan 16, 2026 Why Sponsors Are Moving from CSV to CSA: A Risk-First... Clinical software validation has long relied on the traditional Computer System Validation (CSV) model, which... Learn more
Nov 24, 2025 SaaS-Based EDCs: How Sponsors Can Stay in a Continuous Validation... Electronic Data Capture (EDC) systems are the heartbeat of modern clinical trials. With most platforms... Learn more
Oct 26, 2025 Small Biotech CROs: The Quiet Drivers of Innovation in Clinical... The clinical research ecosystem is undergoing a profound transformation. Emerging biopharma companies, particularly in the... Learn more
Mar 24, 2025 Case Study: Fast-Tracking Pi-Cardia’s FDA Submission with Data-Driven Expertise Accelerating Innovation in Structural Heart Care: Bioforum’s Role in Pi-Cardia’s FDA Journey Bioforum is proud... Learn more
Feb 11, 2025 Navigating the Transition from ICH E6 R2 to ICH E6... As medical writers, staying ahead of regulatory changes is crucial. The Transition from ICH E6... Learn more
Jan 16, 2025 The Evolution of Site Management Organizations: From Patient Access to... Introduction With over 50%[1] of drugs in development reflecting rare/orphan and oncology indications alone, the... Learn more
Dec 05, 2023 Ensuring Data Integrity: Five Key Considerations When Selecting a CRO... Selecting the right Contract Research Organization (CRO) partner is a critical decision for any pharmaceutical,... Learn more
Dec 05, 2023 Unlocking the Power of Data with a Data-Focused Biometrics Service... In today’s evolving clinical research and drug development landscape, with more data sources and technology... Learn more
Jul 10, 2023 Lean Medical Writing Post 2: Lean Medical Writing Strategy By Dionne Crafford In the first of two posts on lean medical writing, we were... Learn more