Services
Data Management
A study database must be complete and accurate. Different processes can contribute to achieve this aim. These processes should be coordinated in order to avoid unnecessary double checks and also to keep the number of possible queries to the study centers as low as possible. Therefore, a “Data Cleaning Plan” is developed which provides an overview of all M.A.R.C.O. processes used in data cleaning and of all parties involved. This improves communication between the Sponsor and the executing parties and supports the Sponsor’s oversight in a study.
Our dedicated data management team supports you with:
- Generation of the “Data Cleaning Plan”
- Generation of the validation plan
- Set-up of (e)CRF applications
- Data base development and validation
- Data entry and verification (double data entry)
- Data cleaning and query management
- Coding of medical terms with MedDRA and WHO-DD
- CDISC / SDTM competence
- CDISC / FDA conform data export
We would be happy to answer your questions about our services personally.