CDM | medONE
Our Service

Clinical Data Management

Phase III and Late phase studies



Clinical Data Management That Makes Data Meaningful

The goal is always the same: Generation of a clean, fully integrated scientific database, ready for statistical analysis. Before we even begin to capture data, We focus on the questions that need to be answered and the goals that need to be achieved. That way we know up-front what data to collect and how to organize it during the collection process. The process for projects begins with the preparation of a Project management plan covering in detail the project organization, the project and work plan.


Then we choose the most appropriate technology to capture and store the data with optimal speed and quality, for clean, clear database demanded by bio-staticians and their computers. Our data management team can target paper-based, and EDC-based systems. From the initial handling of case report forms to completion of the database, our standard operating procedures assure a degree of worldwide consistency, completeness and accuracy.


Supported by our leading-edge data management systems and integrated SOPs, our CDM staff can fulfill unique project requirements, such as:

  1. Quick database set-up
  2. Sponsor-defined CRF and DCF management rules
  3. Customized query wording for clarity and conciseness
  4. Accelerated query management
  5. Unscheduled data reviews
  6. Study time line changes
  7. Changes to Protocol, CRF Template and project specifications

    8. And that's what makes the difference between a confusion of numbers and a clear interpretation of outcomes.



Methodology

Data Management Methodology

The following is a summary of our data management services and procedures:

    eCRF design and implementation.

    Data Management Plan

  1. Project-specific data management standards and SOPs

    2. Database Design
  2. Database definition
  3. Database security
  4. Data entry screens

    5. Data Validation Plan
  5. Initial programming and query wording
  6. Testing and locking data validation plan
  7. Periodic re-testing

    8. Data Entry (paper)
  8. Ongoing data entry from CRF – single or double entry
  9. Data entry cleaning

    10. Medical/Science Review
  10. Review of marginal notes on CRF and Data Alerts
  11. Evaluating medical and scientific consistency of data

    12. Data Validation and Query Management
  12. Periodic validation of CRF data
  13. Flexible query routing
  14. Accommodating 3rd party queries
  15. Query and resolution management over the Internet

    16. Database Lock and Audit

    Database Documentation & Release
  16. Database transfer in Sponsor defined formats