EDC & Data Management
ESTERN Medical Data Management group employs leading technologies, processes and experts to successfully deliver on every project’s specific requirements.
With our collaboration Data Management model, we can offer:
Our long-standing tradition of providing high quality data management services that exceeds our client’s expectations, leading to many partnerships & alliances.
We use well-established and efficient processes Electronic Data Capture (EDC) trials. We support clients in selecting the appropriate technology for each trial based on our experience with several EDC platforms used for clinical trials of variable size and therapeutic areas.
Study documentation is developed to document all steps of the data management process and study specific procedures and includes Data Management Plan, validation checks specifications, study specific guidelines for SAE reconciliation, and medical data coding.
Quality control is built into each step of the process and is documented through a study-specific quality control plan.
Our Data Management Services include:
- Selection of Appropriate Technology and Processes for each Study
- Design/Development of Case Report Form/ eCRFs s and Completion Guidelines
- Investigator Meeting Presentations
- Monitors meeting presentation and training
- Establishment of the Data Management Plan (DMP) and Data Handling Guidelines
- Database Design, Development and User Acceptance Testing
- Data Validation Checks Specification, Programming and Testing
- Patient/CRF Tracking, Entry, and Verification
- Electronic and Manual Discrepancy Identification and Data Clarification Form (DCF) Generation
- Medical Coding
- Integration and Verification of External Electronic Data
- SAE Reconciliation
- Identification and Tracking of Protocol Violators
- Remote Data Access
- eCRF and Query process Metrics, Trends, and Data Reporting
- In-stream Patient Closure and Quality Control Auditing
- Evaluability Meeting Preparation and Attendance
- Accelerated Database Lock
- Final Archiving and Imaging