Within this white paper you will be introduced to Statistical Consultancy for clinical trials and the benefits it can provide.
Advice may cover issues from study design and strategies, to the analysis of study data and informed interpretation of results.
A statistical consultant brings a statistical perspective into the sponsor company, often from a practitioner with a good number of years’ service, who will have seen data of all shapes and sizes, and studies of different designs that either succeed or otherwise.
Key areas explored include:
- The Benefits of Statistical Consultancy
- An objective voice from outside the company
- Time to explore/research/apply
- Experience from outside the industry
- Various models of consultancy
- The Perceived issues
- Examples of Statistical consultancy
- Bayesian Study Designs
- Estimands
- Integrated Summary of Safety (ISS) and Integrated Summary of Effectiveness (ISE)
An ideal paper for device and drug development companies which may not have statistical consultancy resource in-house, or require additional resource to support existing and future studies and are interested in utilizing a CRO or freelance statistician.
