Drafting protocol sections covering design, statistical analysis and sample size
Support in contacts with regulatory authorities
A Veeda CR biometrics project manager assists the project team from early stage in the project development. Advice is offered on study design, determination of study endpoints, and support is provided in contacts with regulatory authorities. Sample size and power calculations are performed based upon the study’s primary objective and hypothesis. Protocol sections covering design, statistical analysis and sample size are drafted in collaboration with the sponsor.
