MDS Pharma Services provides full statistical support for your clinical study. The statistical staff provides input throughout the clinical trial including protocol development, database lock procedures, statistical analysis of safety, efficacy and pharmacokinetic data, production of tables, figures and listings, and data interpretation in the report. The expertise of our statistical staff includes:

• Knowledge of current FDA opinions and methods for statistical analysis
• Experience with statistical analysis of QT/QTc, PK, PD and Biomarker endpoints
• Generation of randomization schedules
• Writing of integrated statistical analysis plan
• Selection of appropriate statistical methods
• Defining analysis populations
• Creation and documentation of logical edit checks
• Conducting blinded reviews of data and interim analysis
• Identifying outliers
• Writing and documenting validated SAS programs for data analysis and reporting

Early Clinical Research

Phase I-IIa

Bioequivalence Studies

PK/PD

Study Design and Protocol Development

Data Management

Statistical Analysis

PK/PD Analysis

Medical Writing and Reporting

Modeling and Simulation

Consultation