Data Management and Biostatistics is the most vital part of conducting clinical trials. Our team works with both paper-based and web-based data.
Our wen-based process implies that data is entered directly from study sites into electronic CRFs (eCRFs). Error checking during data entry at the sites allows early detection and correction of errors including direct checking against source documents. This method helps to avoid additional costs associated with the double entry of data from paper-based forms into the web-database, as well as significantly reduce the terms of data processing.
Data is collected on paper forms and entered by two individuals, each working independently of the other, into two separate data sets. In case of inconsistencies, the reviewer selects the correct data in accordance with the source documents. The results of the review are saved and locked in, in order to prevent any changes from being made.
- Electronic Data Capture in full compliance with CFR 21 part 11
- The software is fully validated and complies with CDISC standards
- A built-in system of randomization
- A module for planning and conducting inventory of drugs and materials for the trial
- Independent double data entry from paper sources
- Data quality control with the use of automated and manual checks
- Coding terms using MedDRA and WHO Drug
- Import of data from external sources
- Generating standard and custom reports
- Statistical analysis of SAS and SPSS data
Results of both internal and external audits of our data base have verified our compliance with all regulation of data feeding of the Russian Ministry of Health, FDA, and EMA.