FGK’s biostatistics team has a wide range of therapeutic experience. Our biometrics services range from statistical planning to analyses, and include sponsor representation at regulatory authority meetings. Our statisticians play an important role in the strategic planning process as they are involved in projects from the earliest stage and provide advice on all aspects of design, sample size, clinical endpoints and conduct of the study. They also work closely with the client, facilitating collaborative, proactive communication.

	Statistical consultancy
	Individual study design, formulation of analysis strategies and sample size calculation consistent with ICH and other regulatory guidelines
	Statistical analysis plans in accordance with sponsor’s specifications
	Statistical programming (descriptive and inferential statistical analyses)
	Statistical reporting
	Attending meetings with regulatory agencies
	Application of state-of-the-art software such as SAS, nQuery, Addplan etc.