The diagnostic odyssey: how misdiagnosis and indication broadening can undermine rare disease clinical trials
Written by Dr Victoria Datsenko, Vice President of Clinical [...]
Post-approval risk management plan updates: what changes, who owns it, and how to avoid compliance issues
In the EU and UK, a risk management plan [...]
Development safety update report writing mistakes that trigger regulator questions (and how to prevent them)
The development safety update report (DSUR) is often the [...]
Drug commercialization: how to build a lean EU and UK launch model without losing control
European marketing authorization can feel like the summit. Years [...]
Clinical protocol design in complex oncology: how to reduce avoidable amendments
More than 90% of oncology protocols implement at least [...]
New drug approvals: how to de-risk the transition from early development decisions to approvable EU/UK submissions
The European Medicines Agency (EMA) and the Medicines and [...]
What to lock down 12–18 months before submitting your marketing authorization application in the EU/UK
The European Medicines Agency (EMA) review clock starts from [...]
6 common pediatric investigation plan challenges US companies face when seeking EU/UK marketing authorization
If you're preparing to seek marketing authorization in the [...]
Strengthening clinical governance for decentralised elements in early-phase clinical trials
Remote engagement is no longer a ‘nice to have’ [...]
Minimising safety concerns in early-phase clinical trial application submissions
Early-phase clinical trials are among the most consequential steps [...]