Study design selection

Sample size calculation / Power analysis

Statistical part of study synopsis and protocol writing

Statistical Analysis Plan (SAP) and Statistical Interim Analysis Plan (SIAP) writing

Programming of summary tables, data listings, graphs and derived datasets

Generation of Tables, Figures and Listings (TFLs)

Conversion of data to CDISC SDTM and ADaM format

Creating, validating and executing SAS programs and macros

Creating and executing SAS edit check programs

Development of protocol specific electronic Case Report Forms (eCRF)

Clinical database setup and validation

Quality assurance (QA) and Quality control (QC) including data quality control checks and data clarifications

Database lock

CDASH (Cllinical Data Acquisition Standards Harmonization) followed in CRF design

SDTM (Study Data Tabulation Model) domains preparation adn datasets programming

ADaM (Analysis Data Model) datasets programming

Define.xml creation

Medical coding using standard dictionaries (MedDRA and WHO DD)

Medical review - professional audits on medical records to identify safety issues and ensure data consistency

Customized approach based on the indication and phase of the clinical trial

Interim analysis for open-label and blinded studies

DSMB: complete management organizational and technical

Preparation of materials for open and closed sessions of DSMB