Vibha is a senior writer covering pharmaceutical and medtech regulatory developments across the globe. She plays a key role in tracking and writing about news of important regulatory issues affecting the sectors, and explaining their implications for industry. Vibha's fields of interest include the EU regulations on clinical trials, pharmacovigilance and pediatrics, on which she has written several exclusive articles from various industry conferences. She has also commissioned some pieces of expert analysis on major developments in the pharma and medtech regulatory arenas.
Latest from Vibha Sharma
The Association of the British Pharmaceutical Industry said 2024 marks the fourth consecutive year of declining patient recruitment in UK industry trials, calling it the most concerning trend despite a surge in trial initiations.
Integrating patient choice in clinical trials is a compelling vision, but achieving it at scale requires balancing flexibility with regulatory compliance, operational feasibility, and data integrity.
Decentralizing clinical research demands rethinking accountability and logistics to prevent gaps that could compromise safety and trial integrity.
Europe’s RADIAL study comparing fully decentralized, hybrid and conventional trial approaches reveals why online recruitment is not simple.
Sponsors and CROs planning commercial trials in the UK can now use a standardized template to confirm NHS site selection and start study setup activities in parallel with formal contracting and regulatory approvals.
While the upcoming EU Biotech Act presents an opportunity to simplify the regulatory landscape for clinical trials, improving the current Clinical Trials Regulation remains the immediate priority.