Data Management

General Data Management

We ensure that data will be collected as intended and analysis objectives are realized. Our data flow modelling, server environment and data security review services are tailored to your needs. We cover full end-to-end control of data collection, processing and archival.  

Our service starts from the technical specification of study variables identified in the Clinical Investigation Plan (CIP), design of electronic case report forms (eCRF), programmatic data quality controls and reporting, transfers of data and eventual data archival. 

Data Protection

We provide data protection services to ensure that the rights of the data subjects are protected in the study “by design” and “by default”. We ensure General Data Protection Regulation (GDPR) principles are applied to the study design development and, provide documents needed to demonstrate compliance. 

Our GDPR services cover principles applied to the study design development, documents needed to demonstrate compliance (“accountability”), and necessary technical and organizational measures.

Biostatistics

We provide biostatistics services and seamlessly integrate experienced external statisticians/biometricians to complement our service. We ensure that biostatistics are correctly applied in your clinical investigation to enable a successful outcome.   

Biostatistics is applied in the design of the Statistical Analysis Plan (SAP) and Statistical Analysis Report (SAR) as well as statistical parts in the Clinical Investigation Plan (CIP).