CLINICAL DATA MANAGEMENT

Our department of data management work closely with sponsor project teams, offer solutions to keep up with the high quality and integrity of clinical study data and to provide strict management on those data.

Our data management team is composed of Clinical Data Associates (CDAs) equipped with medical expertise and Database Administrators (DBAs) equipped with IT specialty.

 

The solutions we offerin include:

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• Database design and Test

• CDASH Compliant deliverables

• Real-time data viewing and reporting

• Database cleaning

• Database Blind Review

• Collection system

• Case Report Form (CRF) Design and Printing, and/or eCRF setup

• CRF Annotations and Database Specifications

• Data management plan creation

• Data Validation Plan& Query Management

• Medical Coding

• DCF Management

• Pharmacokinetic (PK) and Serious adverse effect (SAE) reconciliation

• Database Softlock/Lock

• CRF imaging and edit check specifications

             Data Export/Transfer