- Expertise in proposing best study design based on variability of drug and /or drug product.
- Study protocol development that encompass all regulatory requirements and bio success.
- Application of advanced statistical tools(boost strapping, Monte Carlo simulations etc.) to pilot studies to assess variability, number subjects, sampling points and duration of sampling.
- Outlier tests and regulatory strategies for addressing narrowly failed BE studies.
- Error free documentation, report writing and scientific justification writing.
