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Data Management Services
-Comprehensive Global Clinical Data Management services, that combine our knowledge expertise with the latest technology & tools in EDC systems & data integration.
-BPO services for pharmaceutical, Bio-metrics and medical device industry
Consulting & Strategic Leadership expertise for development of
-Standardized clinical data management
-Standardized EDC Systems & Processes
-Standardized Clinical & Data Management reports
-Submission of Clinical Data to FDA 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
Others
-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
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