Current Edition

Clinical Trial Transparency: New Data Anonymisation Requirements

Faced with new European Medicines Agency (EMA) guidance on the anonymisation of clinical trial data, drug manufacturers targeting the vast EU market have two choices – do what it takes to meet the November deadline – which prioritises clinical study report content – or embrace a smarter and more sustainable strategy that starts with the patient-level data. Chris Olinger, CTO of d-Wise, advises against taking shortcuts.