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/Review Statistical Analysis Plan
Create/Review mock tables and listings
Document/Review exploratory analyses
Program/Review Analysis Datasets
Program/Review SDTM / ADaM submission datasets
Program/Review tables, listings and figures
Program/Review 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 / Review Analysis Datasets
Program / Validate / Review SDTM / ADaM submission datasets
Program / Validate / Review tables, listings and figures
Program / Validate / Review exploratory analyses
Database Lock to Study Finalization
Biostatistics
Generate / QC / Review final analysis datasets
Generate / QC / Review final SDTM / ADaM submission datasets
Generate / QC / Review tables, listings and figures
Generate / QC / Review exploratory analyses
Create / Review Ad hoc / Post hoc Analysis Plans (if necessary)
Generate / QC / Review 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 / Review exploratory analyses
Assist in the creating of presentations and abstracts
Creation of ISS and ISE outputs and reports
