Clinical Data Management: We ensure your data are of the highest quality, reliable and trustworthy.
Capture, comprehend, and report clinical data
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.
Data protection and transparency are top priorities
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
FAQ – frequently asked questions
What is Clinical Data Management?
Clinical Data Management (CDM) is a branch of medical data management that deals with the coding and verification of data collected in medical or clinical trials in which medicinal products and medical technologies are tested. Data management includes data collection and presentation using case report forms (provided in an electronic format), creation of study databases according to regulatory requirements, query management to clarify inconsistencies from plausibility check or missing data, and preparation and transfer of raw data to the biometry department. It is a highly structured area of work that contributes significantly to quality assurance in clinical research.
Why is Clinical Data Management required?
Clinical Data Management (CDM) is needed to ensure that the data as the source material for outcome reports are of high quality, reliable and trustworthy. Clinical data managers check the data against various criteria before releasing it for further processing. Since these study data contribute significantly to the success of subsequent evaluation, data management is an essential component of clinical trials. The increasing awareness of quality assurance and the shifting requirements of authorities, study registries and scientific journals requires the structures handling of study data, making data management a vital component of clinical research in the pharmaceutical industry.
Which standards must Clinical Data Management follow?
When performing Clinical Data Management (CDM), various guidelines and quality assurance measures must be adhered to, including GCP, AMG, and the GCDMP. Common standards such as CDASH and SDTM must be applied when developing databases. For electronic signatures, the requirements of 21 CFR Part 11 are usually mandatory. For validation, appropriate standards such as GAMP5 should be used. Compliance with these guidelines fosters data quality and helps to ensure that the subsequent processing of data is more efficient.