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
Apr 06, 2025 Defining success for early-stage, small biotech trials Small biotech companies encounter significant challenges in designing and implementing clinical development programmes. These companies... 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 17, 2025 Truths About Sample Size and How to Calculate It Sample size is a quantity of immense strategic and ethical importance in treatment development. It... 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 shift 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
Jan 12, 2025 Focusing Too Many R&D Resources on One Drug: The Hidden... Drug development is a high-stakes, high-cost endeavor. Every new drug entering clinical trials requires careful... Learn more
Dec 10, 2024 Value of strategic statistical consultants Value of strategic statistical consultants Many sponsors are restricting the utilization of strategic statistical consultants... Learn more
May 19, 2024 Leveraging Machine Learning For SDTM Mapping Data standards support the robust organization, analysis, and reporting of clinical trials and many regulatory... Learn more
Apr 19, 2024 Case Studies: FSPs in Action If you’re contemplating a Functional Service Provision (FSP) model to enhance your biometric team, understanding... Learn more