Protocal Design and Review

• Advice on study design
• Sample size / power calculation
• Drafting protocol sections covering design, statistical analysis and sample size
• Support in contacts with regulatory authorities

Indochina Labs 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.