EDC & Data Management

COMPREHENSIVE EDC & DATA MANAGEMENT EXCELLENCE AT ESTERN Medical CRO Life Sciences 

The ESTERN Medical Data Management group stands at the forefront of the industry, employing cutting-edge technologies, robust processes, and a team of experts to meet the specific requirements of each project. Our collaborative Data Management model has earned us a reputation for consistently exceeding Sponsor expectations and fostering numerous partnerships and alliances.

Key Features of ESTERN Medical’s EDC & Data Management Services:

1. Leading Technologies: Leveraging state-of-the-art technologies, we ensure the successful delivery of data management services tailored to the unique needs of each project.
2. Collaborative Approach: Our collaborative Data Management model has been a cornerstone of our success, in establishing long-standing relationships and partnerships.
3. EDC Expertise: We support clients in selecting the most suitable Electronic Data Capture (EDC) technology for each trial, drawing on our extensive experience with various EDC platforms across trials of varying sizes and therapeutic areas.
4. Comprehensive Study Documentation: Our study documentation encompasses all facets of the data management process, including the Data Management Plan, validation checks specifications, study-specific guidelines for Serious Adverse Event (SAE) reconciliation, and medical data coding.
5. Quality Control Integration: Quality control is seamlessly integrated into every step of the data management process, with a study-specific quality control plan documenting each stage.

Data Management Services at ESTERN Medical:

1. Technology Selection: Recommending the most appropriate technology and processes for each study based on the trial’s unique requirements.
2. CRF/eCRF Design and Development: Creating detailed Case Report Forms (CRFs) and electronic CRFs tailored to the specific needs of the study.
3. Investigator Meeting Presentations: Preparing and delivering presentations at investigator meetings to ensure clarity and understanding.
4. Database Design and Development: Crafting databases with meticulous attention to detail, followed by thorough User Acceptance Testing.
5. Data Validation Checks: Specifying, programming, and testing data validation checks to maintain the integrity of the study data.
6. Patient/CRF Tracking, Entry, and Verification: Managing patient and CRF data with precision, including thorough verification processes.
7. Discrepancy Identification and DCF Generation: Electronically and manually identifying discrepancies and generating Data Clarification Forms (DCFs) for resolution.
8. Medical Coding: Applying accurate medical coding to ensure consistency and standardization.
9. Integration of External Electronic Data: Validating and verifying external electronic data to ensure seamless integration.
10. SAE Reconciliation: Implementing procedures for the reconciliation of Serious Adverse Events (SAEs).
11. Protocol Violator Tracking: Identifying and tracking protocol violators to ensure data accuracy.
12. Remote Data Access: Facilitating remote data access for enhanced efficiency.
13. Metrics, Trends, and Data Reporting: Providing in-depth metrics, trends, and data reporting for informed decision-making.
14. Quality Control Auditing: Conducting quality control audits throughout the study lifecycle.
15. Accelerated Database Lock: Implementing accelerated procedures for secure database locking.
16. Final Archiving and Imaging: Ensuring proper archiving and imaging for the completion of the study.

ESTERN Medical’s commitment to excellence in EDC and Data Management is evident in our meticulous processes, innovative approaches, and the successful delivery of high-quality services for each project.