Data management
iPharma offers comprehensive data management services within clinical trials. Data is a fundamental element of any study and their integrity, precision and thorough verification are critically important in order for the statisticians to conduct the analysis and forward the results for the final report in a timely manner.
Low-quality data at the statistical handling stage can lead to repeated requests for information from the research centers, exclusion of participants’ data from analysis and even to the risk of failure to achieve the study aims and a denial of the report by the regulatory authorities.
According to the good clinical practice (GCP) manual, the Sponsor and the contract research organization must control data quality and management in all aspects in order to guarantee their reliability and accuracy. At iPharma, all data handling processes are strictly regulated by standard operating procedures of the data management department, the compliance with which is documented and checked during internal audits.
We follow the principle of three-level data validation: the use of verified systems, validation of the specific database and the validation of data itself.
Our specialists use cutting-edge systems for IRC development and data management. If the data need to be presented to foreign regulatory authorities, we can adapt the data in accordance to the SDTM standard. Medical term coding is implemented with the use of the latest versions of the MedDRA and WHO-DDE dictionaries.
The key document which defines data management procedures is the clinical data management plan, which is developed during the initiation of each project and agreed upon with the Sponsor. It includes complete information regarding data management systems, their design, components, verification levels, validation processes and data cleaning procedures.
The data management process involves:
- Developing the clinical data management plan
- Creating a database in accordance with the study protocol
- Programming electronic IRCs
- Developing validation verifications
- Reviewing the clinical data base structure
- Activating the database
- Processing reference values of laboratory indicators
- Automatic data verification on entry
- Creating and processing data clarification requests
- Verifying data listings
- Completing program database checks
- Compiling serious adverse event data
- Medical term coding
- Integration of data from external sources
- Statistical verification of the database
- Closing the data base
- Exporting the data in required formats
After the database is closed, it is forwarded to biomedical statistics and documentation development specialists in order to prepare the final clinical study report.