Feeling overwhelmed? Let us help
Re-imbursement is an important part of product registration and marketing, let us be part of your team. There are times when a successful re-imbursement strategy needs the input from an experienced statistician; a resource not available in-house to all reimbursement teams. This is where we can help! We can work with you when you devise your re-imbursement strategy; planning with the end in mind. We can help you review the information you need and the information currently available. Such information required to underpin your submission may come from:
• Your global clinical trials presented or analysed differently from the regulatory package
• Subgroup analyses from global clinical trials
• Meta analysis of your global clinical trials
• Meta analyses using information in the published literature or available from FDA/TGA websites
• Indirect comparisons and network analyses
• Synthesis of epidemiological data to estimate the patient population or potential market size
• May not be currently available, so we can help you devise a method to obtain what you need as quickly and efficiently as possible; perhaps through a survey, a registry or epidemiological study.
Involving an experienced statistician at the planning stage can improve your chances or being successful the first time; which translates to huge financial gains for your product.