Sep 01, 2025
ICH E6(R3) requires sponsors to perform risk-based, timely, and focused audit trail reviews as part...
May 12, 2025
Artificial Intelligence (AI) has already been used in many areas of clinical development and clinical...
Mar 24, 2025
Accelerating Innovation in Structural Heart Care: Bioforum’s Role in Pi-Cardia’s FDA Journey Bioforum is proud...
Jan 16, 2025
Introduction With over 50%[1] of drugs in development reflecting rare/orphan and oncology indications alone, the...
Apr 19, 2024
If you’re contemplating a Functional Service Provision (FSP) model to enhance your biometric team, understanding...
Apr 19, 2024
Choosing to supplement your internal biometrics team via Functional Service Provision (FSP) offers numerous benefits,...
Apr 19, 2024
Pharma and biotech companies often face the challenge of needing additional biometrics support, whether due...
Mar 18, 2024
Bioforum and Dren Bio (“Dren”) joined forces to focus on Dren’s first clinical trial evaluating DR-01 in patients...
Dec 05, 2023
Selecting the right Contract Research Organization (CRO) partner is a critical decision for any pharmaceutical,...
Dec 05, 2023
In today’s evolving clinical research and drug development landscape, with more data sources and technology...
Sep 11, 2023
Audit trails are a regulatory requirement. How to take an RBQM approach. Audit trails have...
Jul 24, 2023
For many sponsors of clinical trials, particularly the smaller pharmaceutical, biotech, and medical device companies,...