Clinical Data Management

Timely and Cost-effective Services and Solutions

Symbiance’s Clinical Data Management unit has been providing companies with integrated and reliable data management services for over 30 years. Our CDM professionals, bring extensive experience when it comes to managing the widely used EDC systems.

Faster delivery, precise data, and a vital drug development outlook enhances submission timelines. The Symbiance CDM team can be your quality gate for the data coming from your data management vendors.

Why Choose Symbiance CDM?

High-quality data is a top priority at Symbiance’s CDM Unit. But so is your time and your budget. Our dedicated team leaders help you process data that meet our rigorous standards. Always accurate, always accessible, and with a commitment to cost efficiency. Niche services to improve the quality, consistency and integrity of your clinical trial data

  • External data SDTM reconciliation Minimized EDC set-up time
  • Vast experience in supporting EDC systems
  • Fully integrated EDC, IWRS, and medical coding capabilities
  • Strong CFR validated web-based tools
  • Effective integration of external data
  • Medical data review

Symbiance’s Clinical Data Management Provides

  • Access to EDC Solutions
  • Data Management Plan
  • Project Management
  • CRF Design and Development
  • CRF Annotation and Review
  • Database Build and Design
  • Data Validation Specifications
  • Edit Check Programming and Testing
  • Query Management
  • Medical Coding
  • Safety Data Management and Reconciliation
  • Data Transfer
  • Compliant Deliverables

Clinical Technology Expertise

We support EDC Platforms such as: Medidata Rave, IBM Clinical Development, TrialMaster, and Medrio., Clinical studio, RedCap etc.

Quality Gate Keeping Service

Symbiance provides proven Quality Gate Keeping services to enhance the quality, consistency, stability and integrity of your clinical trial data.

We provide:

1. Study Data Tabulation Model Quality Control (SDTM QC)

Our dedicated team of SDTM experts will execute programs that identify the difference between SDTM delivery from the vendors against the sponsor’s standard documentation. These differences will be addressed and fixed in consecutive SDTM deliveries from the CDM vendor.

2. External Data SDTM Reconciliation

Our team of experts analyses and finds the difference between raw external data collected from labs and ECG, and the suitable SDTM domain, in order to provide a reconciliation that is accurate at the SDTM level. Variations that occur are examined by our team and corrected over consecutive deliveries and replicated until all the differences are fixed.

3. UAT Testing of EDC System

Our team has the flexibility to be trained to utilize any EDC system, preferred by the sponsor. Once trained, we execute the proper testing and offer our UAT findings to the EDC development team for implementation. This method permits issues to be addressed and fixed before the EDC system is deployed in production.

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