Data Management
4Clinics Data Management (DM) team will provide project management oversight to ensure the right data collection, high-quality of data and respect of timelines.
Our goal is to collect appropriate data with quality and integrity in order to ensure that the project results and deliverables are reliable and consistent with the protocol requirements.
4Clinics Data Management team works in close collaboration with the clinical and the statistical teams, in a secure and validated environment
Data Management Team
4Clinics Data Management team is composed of Clinical Data Processors (CDPs), Clinical Data Analysts (CDAs) and Clinical Data Managers (CDMs).
CDPs provide operational support. They are dedicated to all aspects of documentation and data collection, tracking and archiving. They perform data entry and QC. They are trained to design and manage the CRF.
CDAs provide technical expertise for Data Management. They set up of clinical databases, program edit checks, upload electronic data, build on-line reports, create data listings, program data mapping procedures, process data mapping and generate SAS copies of data.
CDMs are responsible for coordinating DM activities. They prepare data management/data validation/data mapping plans and reports, and coordinate all data management activities within the timelines and workflow they define. They perform medical coding as well as reconciliation of SAE. They supervise the application of QC procedures and take responsibility for DB locks.
Stemming from its years of experience, the 4Clinics Data Management team has developed expertise using various tools such as:
- Clintrial
- Oracle Clinical
- SAS
- EDC and RDC's tools.
The 4Clinics Data Management team has also a good knowledge of CDISC-SDTM and CDISC-CDASH standards. The use of these global standards will ensure consistency through your different projects. The 4Clinics team can guide you through their implementation.
Data Management Services
4Clinics Data Management team insures the rapid and accurate collection and cleaning of all kind of clinical data by collaborating closely with the different teams, in compliance with regulations, procedures and protocol-required information.
Due to our experience, we minimize the review cycles of all documents and our commitment involves flexibility and support across every part of the trial process.
Our panel of services of Clinical Data Management includes:
- Involvement in development/review of the protocol
- CRF design and printing
- CRF completion guidelines
- Development of project documentation: Data Management Plan, Data Entry Conventions, Data Cleaning/Validation Plan, Data Cleaning conventions, Self-evident corrections, Data Management Report, ...
- Generation of annotated CRF following the sponsor/4Clinics standards
- Database design and set-up
- Validation of the database with dummy patients
- Data extraction, mapping and pooling
- CRF tracking
- Data Entry (double or interactive mode)
- Data Cleaning: checks programming and testing, query management
- Medical term coding (MedDRA, WHOdrug)
- Release of patient profiles and listings
- Performance of medical review
- Quality control of data
- External data uploading (ECG, Ct-Scan, MRI, lab results, drug levels concentrations, PK data ...)
- SAE Reconciliation between the safety database and the clinical database.
- Protocol deviations: definition, detection and evaluation
- Regular reporting: metrics, study status...
- Management of randomisation list
- Participation in the data/blind review meeting
- Database lock (Interim and final lock)
- Data Transfers
- Maintenance of DM study file and archiving
- Data management
- Pharmacovigilance
- Biostatistics
- Medical & Scientific writing
- Regulatory Affairs
- Scientific communications
