Datacare System
The way clinical data is generated has continued to evolve in line with the ongoing development of supporting technologies such as the increasing use of electronic data capture, automation of systems and use of remote technologies. The effort and resource applied to assure the integrity of data should be commensurate with the risk and impact of a data integrity failure to patient and health data. Collectively these arrangements fulfill the concept of data governance. Our expertise enables us to efficiently face the daily challenges of data management and ensure data protection and security.
Server house & data centre technology and procedures
The data collection process must be supported by a secure data management and storage system. Our research projects are based on encrypted servers located in dedicated data centres on our biometric hub. We can rely on a primary data centre and on a second server for daily backups, storage and disaster recovery.
Specialized staff and experts are called upon during the pre-production phases, during the study’s execution, to develop and test custom-made data storage solutions that can support the post-production phase – from raw data collection to final custom data transfer.
Learn how our server services can support your study:
– Support resource sharing across studies in a secure manner;
– Manage longitudinal data for complex and recurring patient visits;
– Automated and manual capabilities for import, export, and data interchange with other systems;
– Rule engine that performs advanced validation of study data and define automated actions within the system;
– Enable compliance with Good Clinical Practice (GCP) and regulatory guidelines, such as 21 CFR Part 11, by means of differentiated user roles and privileges, password and user authentication security;
– Electronic signatures, SSL encryption, de-identification of Protected Health Information (PHI), and comprehensive auditing to record and monitor access and data changes.