The core of all studies is delivering high quality data.
Reliable data that can provide us with more knowledge and the pieces of evidence we are looking for and hopefully in the future, provide us with better medical options and treatments. Both statisticians and data managers are key people in the processing of reliable, high-quality data and both must be involved in the project from the early planning to the final closing. How to handle study data starts with the definition of sample size, power calculations, and endpoints and should address potential data issues, that may cause problems later on.
We mainly use an efficient and fully 21CRF part 11 compliant and validated eCRF solution (Trial-on-Line). A paper-based solution is also an option.
Data Management services include:
- Input to trial design and protocol
- Data Management Plan (DMP)
- Case Report Form design, both paper and electronic
- Database design (variable formats, code lists, logical flows, etc.)
- Validation plan and validation checks
- Database User Acceptance Testing (UAT)
- Data Entry
- Query process
- Coding (adverse events, diseases and medications)
- Final data cleaning and reconciliation
- Database lock and PI signature management
- Database release and transfer of data
- Data management report (DMR)
- Support interim analyses, data reviews and DMC
- System validation
Statistical services include:
- Input to trial design and protocol
- Statistical support regarding regulatory issues
- Sample size and power calculations
- Randomizations design, (incl. envelopes when applicable)
- Preparation of Statistical Analysis Plan (SAP)
- Preparation of statistical analysis report
- Statistical programming (SAS programming)
- Data analysis, final as well as interim
- Preparation of tables, listings, and graphs
- Input to the final clinical study report