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Regulatory Support
Project Management and Administration
Data Management
Statistics and Programming
Data Warehousing
Clinical and Proposal Writing
Our Data Management department is responsible for developing a Data Management Plan (DMP) for each project, which describes and documents the following data management components/activities that are monitored throughout the course of the study:

  • Case Report Form (CRF) Development, including annotated CRFs and CRF completion guidelines.
  • Clinical Data Management System (CDMS): requirements, development, validation plan and user manual.
  • External Data Processing and Data Transfer Specifications
  • Data Coding Specifications, Data Dictionary and Data Validation Specifications
  • Change Management Guidelines
  • Performance and Safety Monitoring Report Specifications
  • Training Activities that align participant recruitment and retention procedures with the protocol, Manual of Operations (MOO) and CDMS.
  • Data Entry Procedures
  • Serious Adverse Event (SAE) Reconciliation
  • Database Lock and Archiving Procedures