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
Sep 16, 2025 All-Patient-Focused Trial Design: Driving Better Outcomes for Patients and Sponsors Most discussions around patient involvement in clinical trial design focus narrowly on the participant... Learn more
Sep 01, 2025 Audit Trails Under the Microscope: What ICH E6(R3) Means ICH E6(R3) requires sponsors to perform risk-based, timely, and focused audit trail reviews as part... Learn more
May 12, 2025 AI for Decision Making: what does AI have to say... Artificial Intelligence (AI) has already been used in many areas of clinical development and clinical... Learn more
Apr 22, 2025 The Data Tsunami: How Clinical Trial Complexity Fuels Warning Letters Eyal Wultz, Bioforum Co-founder and BionData Co-founder and President Data integrity in clinical trials refers... Learn more
Apr 14, 2025 Why Do So Many Clinical Submissions Get a Red Card? Authored by Eyal Wultz, Bioforum Co-founder and BionData Co-founder and President Over the past few... 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