Preparing for the upcoming UK CTR and ICH E6 (R3) changes
Integrating strategic functional consulting expertise to accelerate your drug development timeline
Speed is rarely achieved by pushing one function harder. [...]
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 [...]