We focus on the clear translation of the protocol into CDISC-compliant data structures, efficient data validation and review tools. Each study is lead by a dedicated Project Data Manager, accountable for all data management deliverables. The Project Data Manager acts as the primary contact for all data management activities from planning to risk management to resource management and to operational oversight. The Project Data Manager is supported by an operational team of Senior Clinical Data Managers, Clinical Data Managers and Associate Clinical Data Managers ensuring optimal resourcing and team engagement.
At Accelsiors you can work with our current technology platform that is based on a robust and well-established Electronic Data Capture (EDC) platform, Oracle Clinical and Oracle Remote Data Capture (RDC) or we also have current experience across a number of other leading EDC solutions. Our coding solution employs the integrated Thesaurus Management System.
Our EDC implementation is fully validated and FDA CFR Part 11 compliant. We offer fully CDISC compliant deliverables from CDASH to SDTM mapping.
You can populate our database by external data sources as well and we have extensive experience in the planning, specification, process management and oversight of external vendors: central laboratories, ECG, MRI, biomarker assessments, etc.
A risk-based approach to clinical monitoring can support efficient project delivery without compromising patient safety or data quality. Our Data Center supports you with central monitoring oversight. Operational and clinical data trends are monitored and available for you with real-time input to project delivery. This centralised data surveillance ensures that trial risks are effectively and efficiently managed and you always have eall information on your trial.
WE ARE CONSCIOUS OF THE IMPORTANCE OF:
- Building on industry data standards with clear and efficient translation of protocol requirements to the data capture tools;
- Intelligent data validation and proactive site feedback to drive continuous process improvement;
- Close cross-functional collaboration to drive industry leading cycle times from Last Patient Last Visit to Database Lock.
Data management services:
- eCRF design;
- Development of eCRF Completion Guidelines and Data Entry Guidelines;
- Development of the Data Management Plan;
- Development of the Data Validation Plan;
- Database development, testing, deployment and maintenance;
- Edit check programming and testing;
- Data validation and query management;
- Medical coding and SAE reconciliation;
- Third party data handling and reconciliation;
- Status reporting;
- Database close-out activities;
- Training and support.