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.
|
|