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Clinical Data Management Technologies & Software Services

Data Management Services

WE povides comprehensive Global Clinical Data Management Support Services with state of the art technology in EDC systems & data integration.

  • BPO services for pharmaceutical, Bio-metrics and medical device industry
  • Statistical expertise in study design and Statistical Analysis Plan



1. Technical Consulting & Strategic Leadership expertise for development of :

  • Standardized clinical data management plans and processes
  • Standardized EDC Systems & Processes
  • Standardized Clinical & Data Management reports
  • Submission of Clinical Data to FDA using CDISC standards


2. Warehousing & Integration of Data Management Software/s :

  • I-Review/J-Review
  • DsNavigator / ARISg
  • Cognos and Crystal Reports
  • Clinical Trial Management Systems (CTMS)


3. Technical & Operational Data Management Services :

  • e-CRF and Paper CRF Design and Production
  • Database Design
  • Double Data Entry and Verification
  • Remote Data Capture
  • Patients Screening Log
  • CRF Review
  • Query Management
  • Medical Coding
  • Laboratory Data Administration and Radiology Images
  • Edit Checks and Data Validation QA audits
  • CRF/Edit Check Log and Tracking
  • AEs/SAEs Reporting, Submissions and tracking
  • External Data Loading & Reconciliation(Lab,ECG, PK)
  • SDTM data submission/transfer to FDA



4. Bio-Statistical Programming & Services

  • Clinical Trial Design
  • Statistical meetings/materials, executive summaries, ISS & ISE
  • Sample Size Calculations
  • Statistical Input to Protocols
  • Generation of Randomization Code
  • Statistical Analysis Planning and Interpretation
  • Interim Analysis
  • Generate Top Line results 
  • Statistical Reports


5. SAS - Programming Services

  • SAS Datasets Creation
  • SAP Programming
  • Program Documentation
  • Program Validation
  • Data Listings, Tables, and Graphs
  • Integrated Summaries of Safety and Efficacy Programming
  • Electronic (e-NDA) Submissions
  • Version Control and Archiving
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