Data Management

Our senior data management talents provide high quality and professional data management services to support clinical development.

Data Management System

• Oracle Clinical (Paper)

• Oracle Remote Data Capture (EDC)

 

Data Management Service Scope

Review DM related sections in clinical trial protocol

CRF Design (Including CRF Completion Instruction (CCI) Development)

Data Management Plan (DMP) Development, Data Validation Plan (DVP) Development

Database Setup & UAT (User Acceptance Testing – Data Entry Interface Testing)

Edit Check Programming & UAT (User Acceptance Testing – Edit Check Programming Testing)

Double Data Entry 

Data Review and Data Clarification Form (DCF) Issue & Resolution 

Local Lab Data Management & PK Data Reconciliation

SAE Reconciliation

Medical Coding

Database Quality Control & Database Lock

Data Management Report Development

Original Document Management 

System Training & Technical Support