Large Phase 2 and Phase 3 Studies
Process and Deliverables by Stage
Study Start-Up
Data Management
Review the paper representation of the electronic Case Report Form
Review and provide input into the paper representation of the electronic Case Report Form
Perform User Acceptance Testing on EDC system
Review Case Report Form Completion Guidelines
Review Data Management Plan
Review Data Transfer Specifications
Study Conduct
Data Management
Generate status reports on an ongoing basis to assist with trial monitoring
Generate data listings and patient profiles for sponsor review
Provide CRO oversight
Biostatistics
Create Statistical Analysis Plan
Create mock tables and listings
Document exploratory analyses
Program Analysis Datasets
Program SDTM / ADaM submission datasets
Program tables, listings and figures
Program exploratory analyses
Last Patient Last Visit to Database Lock
Data Management
Generate status reports on an ongoing basis to assist with trial monitoring
Generate data listings and patient profiles for sponsor review
Provide CRO oversight
Biostatistics
Program / Validate Analysis Datasets
Program / Validate SDTM / ADaM submission datasets
Program / Validate tables, listings and figures
Program / Validate exploratory analyses
Database Lock to Study Finalization
Biostatistics
Generate / QC final analysis datasets
Generate / QC final SDTM / ADaM submission datasets
Generate / QC tables, listings and figures
Generate / QC exploratory analyses
Create Ad hoc / Post hoc Analysis Plans (if necessary)
Generate / QC Ad hoc / Post hoc analyses (if necessary)
Interact with the medical writer to generate the comprehensive study report
Assist in the creating of presentations and abstracts
Post Study Finalization
Biostatistics
Generate / QC exploratory analyses
Assist in the creating of presentations and abstracts
Creation of ISS and ISE outputs and reports
