Biostatistics & Statistical Programming Services for Clinical Trials
Sofpromed offers biostatistics and SAS programming services for pharmaceutical and biotechnology companies focused on the devolpment of new drugs. All our services are provided in compliance with ICH guidelines (E9 Statistical Principles for Clinical Trials and E3 Structure and Content of Clinical Study Reports).
Protocol development/review (statistics sections), power and sample size calculations, statistical analysis plans (SAP), randomization processes, blinding/unblinding processes, interim/final statistical analyses/reports, pharmacokinetics (PK) analyses/reports, and Data Safety Monitoring Boards (DSMBs) for randomized trials.
Derived datasets, database standardization for FDA submissions, SDTM and ADaM (annotated CRF, specifications, datasets), define.xml, SAS programming of tables, figures, and listings (TFLs), statistical reports, and validation/auditing of statistical outputs.