IT is not enough
The effective implementation of clinical research projects is dependent on many activities that are closely related to the IT solutions adopted. These activities concern the identification of the main stakeholders of the project to facilitate its approval, the review of the approval process, both from an ethical and privacy point of view, up to the correct execution in terms of internal procedures and training of the personnel involved.
The importance of these activities is greater in the context of observational studies of Real-World Evidence that involve the re-use of clinical data for research purposes.
Consulting services to support clinical research projects
- Assistance in the drafting of SOPs (Standard Operating Procedures) related to the management of installed systems
- Consulting for GDPR compliance verification and data protection impact assessment (DPIA) drafting
- Consulting for the verification of compliance with the minimum ICT security measures for public administrations issued by AgID
- Assistance in the drafting of a Data Management Plan (DMP)
- Support for the drafting of synopses, protocols and scientific projects necessary for approvals at CE (Ethics Committees)
- Provisioning, design and implementation of an AWS (Amazon Web Services) Cloud infrastructure if needed
The BIOMERIS team has a decade of experience in projects involving the reuse of clinical data for research purposes. During these projects it has developed a consolidated ability to support researchers in various activities related to the IT solutions adopted.