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Biostatistics

Our biostatisticians team are well experienced, produces comprehensive, high-quality, timely analysis and reporting of study results across a broad range of therapeutic areas. We have extensive knowledge of experimental design, statistical methodology, and global regulatory requirements.

Clintrac has highly qualified professionals in statistics and SAS programming, have vast knowledge in efficient trial designs. We advance every study with the endpoint in mind by applying our clear understanding of regulatory requirements, statistical programming applications and experience in a variety of therapeutic areas. A carefully designed analysis plan is an essential prerequisite to a thorough analysis through accurate interpretation of the study data. 

Our team provides insight into trial design, develop complex statistical analysis plans and support the sponsor through-out the regulatory filing process. Our team dedicate themselves to a clinical project from initiation to completion. Our aim is to deliver clean and accurate data and lock the database on time.

Our biostatistics services include:

 

Sample Size & Power Calculation.

Statistical Inputs for Protocol Preparation.

Validation of Biostatistical Programs and Outputs.

Statistical Analysis Plan SAS Programming using SASŪ9.1.3.

PK/PD Analysis.

Analysis Programming.

Inputs to Clinical Study Reports.

Statistical Report Writing.

Interim Analysis.

Randomization and Unbinding Procedures.

Statistical Analysis Plan.

Integrated Clinical Safety & Efficacy Summary.

 

 

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