The MHICC Biostatistical team is made up of biostatisticians coming from a wide range of academic and pharmaceutical backgrounds. For more than 20 years, our team has been involved in the design and analysis of large phase II-IV registered clinical trials as well as academic studies. Regardless of the size of the study, we are dedicated to provide sound statistical methodology recommendations to optimize study design and answer study objectives while maintaining the highest level of scientific integrity. We are also committed to excellence in our statistical programming activities to produce high quality statistical outputs and reports. We are responsive, efficient, accountable and believe in the importance of developing a close relationship with our clients to meet study objectives and timelines.

Our team provides the following services:
• Sample size and power calculation
• Statistical expertise in protocol development
• Randomization list
• Statistical analysis plan
• Generation of derived datasets, including in CDISC format (ADaM, define.xml files, reviewer’s guide)
• Generation of tables, listings and figures
• Generation of statistical reports
• Statistical review of clinical study reports
• Support to data safety monitoring boards or other safety committees, including interim analyses
• Statistical writing for clinical study report, abstracts, publications, etc.
• Participation in discussions with regulatory agencies
• State-of-the-art Statistical Software, mainly SAS and nQUERY