Clinical data management

From initial CRF design to final database lock, we manage the full data lifecycle with a clear focus on quality, efficiency and traceability. Our approach ensures that your data is not only correct, but also ready for analysis and submission without unnecessary delays or rework.

CRF design and development

Design of paper and electronic Case Report Forms (CRFs), structured to capture data in a clear, consistent and analysis-ready format.

Database setup

Configuration of (e-)clinical databases aligned with study requirements, including CDASH standards where applicable.

Data validation and medical review

Implementation of validation checks and ongoing data review to resolve discrepancies through queries, ensuring accuracy, consistency and completeness.

Clinical coding

Coding of medical terms, such as adverse events, medical history and medications, using standard dictionaries like MedDRA and WHO Drug to support consistent interpretation and analysis.

SAE reconciliation

Reconciliation of serious adverse events across datasets to ensure completeness and regulatory compliance.

External data integration

Integration and reconciliation of external data sources, such as laboratory or imaging data, into the clinical database.

CDISC SDTM conversion

Preparation of datasets in CDISC SDTM format to support regulatory submission.

Common challenges we help prevent

• Inconsistent or incomplete data capture due to unclear CRF design
• Data discrepancies between clinical, safety and external data sources
• Delays caused by late identification of data quality issues
• Misalignment with CDISC or regulatory standards
• Time-consuming database cleaning at the end of a study

The result

A clean, consistent and well-documented database that supports reliable analysis and meets regulatory standards.

How we work

Our approach is structured and transparent. We focus on data quality from the start, apply consistent processes and ensure that all steps are clearly documented and traceable.