Data Management and Statistics
Data Management
ORION's team of Data Managers, Data Coordinators and Data Entry staff all work in close collaboration with the Clinical Operations, Project Management and Pharmacovigilance teams.
The team has particular strong expertise in managing studies that involve large and complex case report forms.
Our services include:
- Database design and validation
- Development of query resolution conventions
- Independent double data entry and reporting
- QC of database and database lock
- Blind review and reporting including ongoing safety table generation if required
Statistics
Our dedicated team of Statisticians and SAS programmers works in close collaboration with the Data Management, Clinical Research, Medical Writing and Project Management teams.
Our services include:
- Statistical consultation
- Preparation of the statistical sections of protocols
- Preparation of randomisation lists and central randomisation
- Preparation of Statistical Analyses Plans
- Preparation of the statistical sections of clinical study reports