Data management / IWRS
Smooth Drug Development provides data management services in clinical trials.
The data are the cornerstone of any clinical trial. Complete, accurate, thoroughly reviewed data allow statisticians to perform statistical analyses as scheduled and provide the results to medical writers for the Clinical Study Report preparation.
Poor quality of data at the stage of statistical analysis may require repeated contacts to investigational sites with queries, exclusion of subjects from the analysis, as well as threaten the achievement of the trial endpoints and the approval of the Clinical Study Report by regulatory authority.
ICH GCP requires a Sponsor and CRO to perform quality control at each stage of data handling to ensure that all data are reliable and have been processed correctly, as well as use validation systems and use of standard operating procedures for all trial related activities. That is why all aspects of data handling in our company are regulated by standard operating procedures of the IT & Data management department, and the compliance is carefully documented and verified during internal audit.
In data management process we adhere to the principle of a triple validation: using validated systems, validation of a particular database, validation of the data.
For a long time the main instrument for data collection was a paper Case Report Form (CRF). In today's world the use of paper CRFs is more logistically complex, increases the time and cost of research, that's why in 2013 our company has completely transferred to electronic CRFs. Since 2013 the company conducted 60+ studies using electronic CRFs, developed and validated by specialists of Data management department of our company.
For eCRF development our data management specialists use inhouse platform for data management Smooth CTMS. The system is fully compliant with the Title 21 CFR Part 11 and CDISC requirements. When needed the data may be presented in SDTM format. Medical coding is performed using the latest versions of MedDRA and WHO-DDE dictionaries.
The main document regulating the handling of data in a clinical trial is the Data Management Plan, which is being developed at the beginning of the study and approved by the Sponsor. This document contains all information about how to perform data management in the particular study: systems used, system design and management components, the levels of checks, the description of data validation and cleaning procedures.
Data management process includes:
- Development of Data Management Plan
- Development of a clinical database
- Programming of the e-CRF
- Programming of the validation checks
- Validation of the structure of clinical database
- Transfer to production mode
- Collection and processing of the laboratory references
- Automatic data checks at the entry
- Creating and processing of data queries
- Data listings review
- Perform programmed database checks
- Reconciliation of Serious Adverse Events
- Coding of Medical Terms
- Data transfer from external sources
- Blinded database check by statisticians
- Database lock
- Export data into the required formats
After the lock the database is sent to biomedical statisticians and medical writers of the company for preparation of a Clinical Study Report.