Process of collecting and managing research data is done in compliance with Regulatory Requirements.
Agati Clinical provides the experienced Data Management team which has the capability to work on any EDC platform and on bespoke customer platform as well. Due to the complete understanding of end to end processes, our team can suggest the right solutions to the problems with an eye for detail resulting in total customer satisfaction. Agati Clinical has the rich experience in providing and implementing process automation which increases throughput, decrease the time per study and significant cost savings.
Study Start-Up
• Input to protocol design
• Project Planning
• Creation of Data Management, Plan and Data Validation Plan
• pCRF/eCRF Design
• Database Design and Edit Check Programming
• Database Testing and UAT
• Data Migration
• Data Review & Query Management
• External Data Management
• SAE Reconciliation
• Medical Dictionary Coding
• Quality Control Activities
Study Start-Up
• Input to protocol design
• Project Planning
• Creation of Data Management Plan and Data Validation Plan
• CRF/eCRF Design
• Database Design and Edit Check Programming
• Database Testing and UAT
• Data Migration
Study Conduct
• Data Review and Query Management
• External Data Management
• SAE Reconciliation
• Medical Dictionary Coding
• Quality Control Activities
Study Closure
-
Project Documentation (Data Master File)
-
Database Lock
-
Submission Ready CRF / PDFs
-
Data Transfer
-
Archival
