Ergomed offers full data management services no matter what phase or type of clinical trial.
At Ergomed, clinical data management is performed by experienced teams with a breadth of knowledge and expertise. We cover the full range of services from eCRF design to the creation of a clinical database, delivering clean data ready for statistical analysis.
Unlike other clinical research organizations, we don’t try to fit your clinical study into our software. Instead, each study we undertake is custom-designed to capture your clinical endpoints in the most effective way, while always ensuring the integrity of the data.
We offer an in-house electronic data capture solution that is fully compliant with the requirements of FDA 21 CFR Part 11 and EMEA Annex 11, as well as fully equipped to support other industry-standard EDC systems.
Our data management teams offer:
- Case report form (CRF) design
- Inhouse EDC system with integrated randomization module
- Database design and build according to CDASH standard
- Data integration from all sources
- Medical coding (MedDRA, WHO Drug Global)
- Data cleaning with query management
- Online and Offline edit check programming
- Patient report outcomes (PRO) management
- Patient Profiles
- Data Review Meetings