Design clinical trials, including sample size calculation and randomization.
- Assisting in the design of Clinical Trials and PMCF surveys to ensure robust and valid statistical outcomes.
- Developing comprehensive statistical analysis plans (SAPs) that outline methodologies, data handling, and analysis strategies.
- Ensuring alignment with regulatory standards and best practices in biostatistics.
Customized Statistical Plans for PMCF Studies:
Developing statistical analysis plans specifically for PMCF studies to monitor ongoing device performance and safety.
Assist with statistical sections of regulatory submissions (FDA, Notified Body, etc.), ensuring compliance with relevant guidelines and standards.
Determining appropriate sample sizes to ensure statistical power and reliability of study results. Providing guidance on optimizing trial design to achieve meaningful outcomes with available resources.
Implementing randomization techniques to minimize bias and ensure balanced allocation of participants.
Utilizing methods like group sequential designs to allow modifications based on interim results.
Implementing Bayesian approaches for prior information incorporation and adaptive trial designs.
