The diagnostic odyssey: how misdiagnosis and indication broadening can undermine rare disease clinical trials
Written by Dr Victoria Datsenko, Vice President of Clinical [...]
Clinical protocol design in complex oncology: how to reduce avoidable amendments
More than 90% of oncology protocols implement at least [...]
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 [...]
Translating an early clinical development plan into an effective site and patient selection strategy for rare disease clinical trials
The global rare disease clinical trials market is projected [...]
Designing early-phase clinical trials for advanced therapeutics: key considerations and challenges
Entering early‑phase clinical development with a novel advanced therapeutic [...]
The future of the rare disease landscape and the value of CRO support in this specialist area
The World Health Organization (WHO) defines a rare disease [...]
FDA provides new guidance on conducting clinical trials with decentralised elements
Clinical studies have traditionally required participants to come to [...]
The role of pharmacovigilance in oncology drug trials
Some of our experts recently penned a thought-provoking article [...]