Clinical Data Management: We ensure your data are of the highest quality, reliable and trustworthy.
Clinical Data Management refers to processes that collect, manage and use data and is a general term for a wide variety of tasks. As a branch of medical data management, clinical data management encompasses the review and coding of data collected in research studies.
Due to the continuously shifting legal regulations and the increasing awareness of the protection of sensitive data, quality assurance and quality control, data management is becoming increasingly important and is an essential part of clinical studies.
Transparency of all work steps and high-quality processed data are crucial for reproducible and traceable results as well as reliable statistical evaluations.
From collection to analysis – we ensure that your data is of the highest quality, reliable and trustworthy.
During a clinical trial, collected information needs to be structured to enable precise, scientifically sound analysis. Via the use of state-of-the-art software and online technology, we are able to ensure an essential goal of data management: data quality.
Based on our experience and field-tested procedures, as well as our commitment as a member of the Society of Clinical Data Management (SCDM), we can ensure the fast and secure handling of sensitive data.
Our services include:
- eCRF design and generation of annotated CRFs
- Database design, programming of data entry screens and edit checks
- EDC and double data entry
- Transfer and integration of external data (e.g. laboratory)
- Coding (adverse events, diagnosis and concomitant medication)
- Data validation and query management
- Quality control and database locking
- (Blind) data review
- Reconciliation of SAE data
- Preparation of status reports and statistics
- Preparation of statistical or integrated final reports