Strengthening rare-disease pharmacovigilance with curated real-world data
By Lucy Fulford-Smith, Head of Pharmacovigilance & Medical Services [...]
Navigating the first regulatory milestone: how to prepare a successful clinical trial application
Submitting a clinical trial application (CTA) is a pivotal [...]
The 5 key stages of the drug commercialisation process explained for first-time sponsors
Between 2020 and 2023, 173 innovative medicines received marketing [...]
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 [...]
Employing advanced analytics and artificial intelligence in rare-disease pharmacovigilance
By Lucy Fulford-Smith, Head of Pharmacovigilance & Medical Services [...]
The limits of traditional pharmacovigilance in rare diseases
By Lucy Fulford-Smith, Head of Pharmacovigilance & Medical Services [...]
How to choose the right functional service provider operating model for scaling your drug development programme
For small to mid‑sized biotech and pharma companies, building [...]
Designing early-phase clinical trials for advanced therapeutics: key considerations and challenges
Entering early‑phase clinical development with a novel advanced therapeutic [...]
How to craft an effective EU pharma strategy for small to mid-sized biotech and pharma companies
The European market offers a large patient base, strong [...]
How to integrate early access programmes into your pharma market access strategy
Access is everything for rare disease patients, who often [...]