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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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