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Data Management Services

High-quality data is one of the most critical elements of all clinical trials. Thus, data management is a core service of I28Tech and a critical element of our customer value proposition. Our Data Management team is headed by one of the leading experts in the field of Data Management. Our Comprehensive Global Clinical Data Management Services that combine our expertise with the latest technology, tools in EDC systems and data integration.

 

I28Tech offers the following Data Management Services:

 

  • e-CRF and Paper CRF Design and Production
  • Electronic and facsimile data capture
  • Database Design and Validation
  • Interactive drug management and drug supply
  • Laboratory data management (Lab, ECG, PK)
  • Radiology Images Management
  • CRF/Edit Check Log and Tracking
  • Query Management, Query Generation and Resolution
  • Adverse Event and Concomitant management.
  • Safety procedures AEs/SAEs Reconciliation, reporting and management of protocol violations, deviations, and endpoints
  • Medical coding using standard dictionaries; MedDRA, WHO-DD, and sponsors dictionaries
  • Data validation, review, and cleaning
  • Quality Control to highest standards, with Quality Control Management processes and ensure high-quality data
  • Management of data of third party vendors, data consolidation and conversion
  • Submission and transfer of Data to Sponsor, Regulatory Agency using CDISC standards

 

Warehousing & Integration of data management software

 

  • I-Review/J-Review
  • DsNavigator / ARISg
  • Cognos and Crystal Reports
  • Clinical Trial Management Systems (CTMS)
  • Statistical expertise in study design and Statistical Analysis Plan

 

Data Management-BPO Model in India

 

  • Strategic control of studies and the Data
  • Encapsulation of In-house Knowledge by Sponsor
  • Operational Cost Optimization
  • Achieving timeline targets
  • Efficient use of limited resources
  • Standardization of processes
  • Data Security & Integrity
  • Training Clinical Sites and Investigators for EDC
  • Consistency in Deliverables
  • Being true partner's of sponsor.

 

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