Statistical Analysis Plans
Pre-defining your approach to clinical trial data summary and analysis is essential. KJC statistics can assist you in preparing high quality SAPs for your clinical trials and trial programmes.
Statistical Input to Preparation of Regulatory Briefing Materials
Careful and concise wording of regulatory background briefing materials and questions to the authorities is essential to get your ideas and proposals across and pave the way for productive face-face interactions. KJC Statistics has extensive experience writing, reviewing and shaping regulatory meeting briefing materials.
Statistical Review of CTD Submission Documentation
KJC Statistics has experience of multiple product license dossiers and applications. Experienced statistical input is essential to deliver scientifically credible and compelling arguments based on trial data and analyses. KJC Statistics will help you to deliver submission documentation of the highest scientific quality and persuasiveness.