Esculape offers integrated and customised solutions for most data management topics, including data management oversight, within clinical operations.
We support our clients as a sponsor in their duties, providing hands-on activities to perform classical data management tasks. Furthermore, we ensure study data quality and integrity from the set-up phase to successful finalisation.
Data management oversight
Esculape remains dedicated to supporting clients as sponsors, with our expertise in all relevant data management aspects within the responsibility of sponsor oversight.
We look at individual study data in its entirety and include risk-based approaches, as well as the translation of clinical reality into the Electronic Case Report Form (eCRF). We often function as an intermediary between Clinical Operations and the Contract Research Organisation (CRO).
Comprehensive range of services provided
Our services include review of all data management documents and User Acceptance Tests. We provide arrangements concerning the eCRF such as timelines, data transfer and reconciliation, as well as review of quotations and cost control.
We offer support for the selection of the appropriate eCRF, including analysis and management of its demands, validation, standard operating procedure (SOP) creation and implementation, as well as qualification or project audits.
Esculape provides long and short-term planning, design and CRO selection services for new studies. Enhanced data management oversight is offered for running studies.
Data management CRO
Data management processes are implemented in a project. However, if a lead or project data manager is missing, we offer creation of a data management plan and report, data validation plans / eCheck and reconciliation. Coding, data transfer, such as agreements and definition, and data review / query management can be provided.
Clients may rely on our assistance for a defined period or long-lasting cooperation and we can adjust to their needs.
Data management training
At Esculape, we believe that knowledge and expertise flourish through communication and exchange.
If potential customers feel the time has come to set up in-house data management but require support in doing so, or find that all details and complexities of data management are not yet internalised, we can customise training according to individual aims and needs.
Data protection and safety
Esculape is committed to data, including in management and protection. For German companies in the clinical realm, we can be an outside privacy officer and conduct external data privacy audits with a focus on evaluation and guide. We can set up and implement data privacy guidelines for quality management systems, including consulting and training internal personnel.