New EDPB Opinion: Vendors in Clinical Trials
The European Data Protection Board (EDPB) recently issued Opinion 24/2024, focusing on a critical aspect of data protection compliance:...
Unpacking FDA Guidance on Digital Health Technologies in Clinical Trials
Digital Health Technologies (DHTs) use in clinical research is no longer a futuristic concept—it’s quickly becoming the norm. Recognizing...
How Geopolitical Economic Changes Are Impacting Big Pharma
Globalization has long been seen as a cornerstone of growth for the big pharma industry, enabling companies to expand...
Transparency and Anonymization in Research: EMA Guidelines
As the clinical trial landscape evolves under the EU Clinical Trials Regulation (CTR), transparency and privacy have become central...
EHDS & GDPR Compliance: Urgent Action Needed for Biopharma
In the rapidly evolving landscape of health data regulation, the European Health Data Space (EHDS) initiative marks a transformative...
Unpacking New FDA Guidance: Processes and Practices for BIMO Inspections
The U.S. FDA issued a draft guidance document, “Processes and Practices Applicable to Bioresearch Monitoring (BIMO) Inspections,” to streamline...
Real-World Data in Clinical Trials: Benefits & Privacy Risks
The landscape of clinical trials is experiencing a paradigm shift with the integration of Real-World Data (RWD). Traditionally conducted...
The Trial Master File: A Window into the Quality of Any Clinical Study
In the complex and highly regulated environment of clinical trials, the Trial Master File (TMF) is a foundational tool...
Clinical Trial Recruitment: Can a Comparative Analysis of Database-Driven, Digital Technology, and Integrated Strategies Break the Cycle?
Patient recruitment and retention are among the most critical challenges in the fast-evolving world of clinical trials. In 2000,...
AI in Research: Key Takeaways from the EU AI Act
Artificial Intelligence (AI) is playing an increasingly significant role in scientific research and development (R&D), particularly within the biopharmaceutical...