Privacy Now: Balancing Innovation and Privacy in Genomics
The UK’s Information Commissioner’s Office (ICO) recently issued a critical call for collaboration in genomics, emphasizing the need to...
How GDPR Drives Trust in Patient-Centric Trials
In recent years, patient-centric trial designs have emerged as a transformative approach in clinical research, placing patients at the...
Alzheimer’s Trials and Others See More Diversity When Technology and Humans Work Together
Clinical trial sponsors are facing mounting pressure to secure trial participants that more closely reflect the diverse populations affected...
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The U.S. FDA issued a draft guidance document, “Processes and Practices Applicable to Bioresearch Monitoring (BIMO) Inspections,” to streamline...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...