Proven expertise in applied statistical analysis, data management and sample surveys

Expert Clinical Data Management

MCG provides a complete clinical data management service using a standards driven approach to assure quality data for your clinical trial. These data quality procedures include:

  • Oversight/Project Management of Data Management activities (DMP/DQP)
  • Protocol review and input into design
  • eCRF and paper CRF development and review as well as associated completion guidelines and annotations
  • Site/monitor Training on CRF/eCRF completion
  • Database design and build
  • Development of data validation specifications
  • Programmed validation checks
  • Data Processing
  • Query management
  • Medical Coding
  • Management of laboratory data
  • CDISC compliant deliverables
  • Data export/transfer
  • Management of Central Laboratory Data
  • Reconciliation of Adverse Event data

The MCG clinical data management team have many years of high level Clinical Data Management experience and are experts at liaising with the stakeholders of clinical trial teams; and providing the project management skills to bring your trial successfully to database lock. One of our lead Clinical Data Managers will work closely with you to define individual clinical data management requirements for your project. Our data managers have extensive experience in management of data from Phase 1 through to Post Marketing.

MCG can use in-house standard operating procedures and data standards or adopt your company's specific standards. MCG systems and processes will deliver reliable, accurate and validated data for your project.

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MCG's chosen clinical database solutions are US FDA Title 21 CFR Part 11 compliant and provide fast eCRF and database creation. MCG will tailor your data quality plan to the needs of your study. The MCG eCRF computer system has both hardware and software redundancy thus providing the reliability that your clinical data demands.