Clinical Data ManagementClinical Data Management
Affordable and Efficient Services and Solutions
Clinical Data Management
For more than three decades, Medkine’s Clinical Data Management division has been delivering dependable and integrated data management services to companies. Our CDM experts possess extensive experience in operating widely used EDC systems.
Accelerated delivery, accurate data, and an essential perspective on drug development improve submission timelines. The MEDKINE CDM team can serve as your quality assurance for data obtained from your data management vendors.
Reasons to Select MEDKINE CDM?
Ensuring high-quality data is a primary focus for MEDKINE’s CDM Unit. However, we also understand the importance of your time and budget. Our committed team leaders assist you in processing data that align with our strict standards. Always precise, always available, and dedicated to cost-effectiveness. Specialized services aimed at enhancing the quality, consistency, and integrity of your clinical trial data.
- Reconciliation of external data with SDTM has reduced the time required for EDC setup.
- Extensive experience in assisting with EDC systems. Comprehensive integration of EDC, IWRS, and medical coding functionalities.
- Robust web-based tools that comply with CFR validation.
- Efficient incorporation of external data.
- Review of medical data.
MEDKINE’s Clinical Data Management Provides
- Availability of EDC Solutions
- Plan for Data Management
- Overview of Project Management
- Design and Development of CRFs
- CRF Annotation and Evaluation
- Creating and Designing Databases
- Specifications for Data Validation
- Programming and Testing of Edit Checks
- Management of Queries
- Medical Coding Services
- Management and Reconciliation of Safety Data
- Data Transfer Processes
- Deliverables that Meet Compliance Standards
Expertise in Clinical Technology
We provide support for EDC Platforms including Medidata Rave, IBM Clinical Development, TrialMaster, and Medrio, as well as Clinical Studio, RedCap, and others.
Quality Control Oversight Service
Symbiance offers reliable Quality Gate Keeping services to improve the quality, consistency, stability, and integrity of your clinical trial data.
Our services include:
1. Study Data Tabulation Model Quality Control (SDTM QC)
Our skilled SDTM professionals will implement programs that pinpoint discrepancies between the SDTM submissions from the vendors and the sponsor’s standard documentation. These discrepancies will be resolved and corrected in subsequent SDTM submissions from the CDM vendor.
2. External Data SDTM Reconciliation
Our group of specialists assesses and identifies the discrepancies between the raw external data obtained from laboratories and ECG, along with the appropriate SDTM domain, to ensure a precise reconciliation at the SDTM level. Our team reviews any variations that arise and makes corrections over successive deliveries, continuing this process until all discrepancies are resolved.
3. UAT Testing of EDC System
Our group is adaptable and can be trained to use any EDC system chosen by the sponsor. After receiving training, we carry out the necessary testing and provide our UAT observations to the EDC development team for their incorporation. This approach allows for problems to be resolved and corrected prior to the EDC system being launched in production.