Data Management and Statistics
We are a world class Clinical Research Centre offering the full range of data management and statistical services. The Data Management and Statistics team have many years' experience of processing clinical trial data to ICH/GCP standards, and are able to provide services ranging from CRF design through to statistical analysis. The team is able to provide all or some of the following activities which can be tailored to address individual needs:
Data Management
- Case Report Form (CRF) design either from client/sponsor specifications or using Surrey Clinical Research Centre standard modules
- Annotation of CRFs and creation of a Data Specification Plan
- Database design for inhouse data entry using SigmaSoft DMSys and Microsoft Visual Foxpro. The DMSys system is 21 CFR part 11 compliant
- Pre-entry review of completed CRFs
- Data entry, verification entry and a comparison of the two
- Running of 'within form' and 'cross form' consistency checks
- Raising of queries and submission to client/sponsor
- Resolving of queries and correcting data as required
- Coding of medical data using the MedDRA and WHODrug dictionaries
- SAS programming for data extraction and importation of electronic data
- Submission of data in Excel or SAS format
Statistics
- Sample size determination and input regarding the trial design and Protocol, including definitions of populations and methods to be used for analysis
- Preparation of a Statistical Analysis Plan
- Preparation of Randomisation lists
- Programming for statistical analysis
- Generation of figures, tables and listings
