DATA MANAGEMENT

Data Management is a key component of the clinical development process. High quality data provide the foundations from which the results and conclusions of the study are derived, and therefore thorough data management is fundamental.

All key stages in the data management process are critical to ensure the high quality of the study results. These range from data collection on paper (hard copy) or in electronic format, through to data checking, entry, coding, auditing and export for subsequent statistical analysis.

Our ORACLE based Data Management software (Capture System®) enables us to provide a full range of Data Management services including Electronic Remote Data Entry. Our system has been validated internally and is compliant with regulatory requirements, including the FDA's "Guidance for Industry: Computerized Systems Used in Clinical Investigations" and document 21 CFR Part11 on electronic records and electronic signatures.

ONDAX Scientific can provide a full Data Management service or any of the individual services described below:

• Data Management Plan development
• Database design
• Data entry (single/double/double interactive)
• Data cleaning and resolving data queries
• Electronic CRF design
• EDC (Electronic Data Capture) System
• Consistency test programming
• Randomisation plans
• Coding (VEDDRA, WHODRUG, etc.)
• Exporting data for statistical analysis (SAS, SPSS, ASCII, HTMLA, etc.)