Data management

Data management services can be included in a “Full-service package” or performed
“à la carte” according to Sponsor’s requirements and sub-contracting strategy.
Our data management specialists are key members of our multidisciplinary team and
work closely with the IT developers, statisticians and clinical operations.
They contribute to study design as well as data collection, validation and analysis,
for greater efficiency, quicker problem-solving and reduced follow-up time.

OUR SERVICES INCLUDE:

• Protocol review, blank CRF review
• Data Management Plan (DMP) and Data Validation Plan (DVP) development: for every trial we develop a detailed plan on how study data is captured and handled from study start to database lock
• Clinical database creation, validation, and auditing (annotated CRF, dictionary of variables, SAS format database), data entry screen/e-CRF
• Edit Check Programming, Development, and Testing
• Design and development of CRF/e-CRF and other collection tools (e-PRO) in close collaboration with the IT department, the project manager and the medical and scientific affairs department
• Expertise in data flow and interoperability for the management of decentralised studies
• Management of protocol deviations and intercurrent events (in close collaboration between data managers, statisticians, and CRAs): our data managers perform regular reviews of the trial data and solve any discrepancies by efficient query handling processes. Standard reports provide data managers and Sponsors with study status in real-time
• Adverse event, concomitant medication, and medical history coding (MedDRA, WHO-DDE…) and medical validation
• SAE reconciliation between safety and clinical databases
• External data transfers management
• CDISC SDTM mapping
• Database anonymisation
• Organisation of data review meeting(s) for interim and final analyses
• Database lock and freeze