Data Management
We are your one-stop shop for all clinical investigation data management needs.
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).
Read more in our blog
Data management in clinical investigations - Part 1: Study variables
The high quality of clinical investigation data is critical for demonstrating the performance and safety of a medical device.
Data management in clinical investigations - Part 2: General data protection regulation
Sensitive personal health data is being collected and processed in clinical investigations aiming to demonstrate the performance and safety of medical devices.
Data management in clinical investigations – Part 3: Data traceability
Data traceability is a foundational principle for clinical investigations aiming to demonstrate the performance and safety of medical devices.
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Meet us in Tomar, Portugal
Labquality will attend SPML's (Sociedade Portuguesa de Medicina Laboratorial) 16th scientific meeting in Tomar, Portugal, from 12 to 13 April 2024.Meet us at ECCMID in Barcelona
Visit our booth E5 in the ECCMID exhibition and hear about EQA services for microbiology, as well as CRO services for pharmaceuticals and MD/IVD manufacturers.Why Modeling Data Flows Is Needed in Clinical Investigations
data management manager explains how data flow modeling will help keep clinical investigation stakeholders informedEQA Coordinator Anna-Riitta Vanhanen Retires After 34 Years of Service
EQA Coordinator Anna-Riitta Vanhanen is retiring in the autumn of 2024 after working at Labquality since 1990. Biochemist Hanna Heikkilä will take over Anna-Riitta's EQA rounds.Read now the new customer reference
Peili Vision has chosen Labquality as the partner for a clinical study to assess the performance and safety of their browser-based, game-like medical software.Subscribe to our newsletter
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