Clinical Data Management

What is clinical data management?

The accumulating, documenting and storing data, critical for clinical trials or other clinical procedures, critical to pharmaceutical manufacturers and Bio Tech companies is called Clinical Data Management. Clinical Data is usually stored in a data repository known as Clinical Data Repository, which stores data mostly in a patient centric fashion, accumulating data from multiple sources. Clinical data repositories may form Clinical Data Warehouses, when the data stored in them is specifically organised for analytics purpose. Commonly used Clinical Data Management tools are:

  • Oracle Clinical
  • Clintrail
  • Macro
  • Rave
  • eClinical Suite

Most organisations outsource the Clinical Data management process to IT service providers/partners, in order to focus on their core competencies of pharmaceutical or clinical research. The process of outsourcing the Clinical Data Management helps Pharmaceutical/Clinical Research companies reduce their Operational Expenditure and allocate Capital Expenditure to other useful activities such as research and development.


Clinical Data Management

The majority of commercially available legacy clinical study data conversion solutions are resource intensive. Manual execution steps and poorly executed re-usable components prevent efficient processing and need to be repeated for each conversion endeavor. Data quality and validation tasks are cumbersome and rarely automated, which leads to increased costs.


As per the regulations published on January 16th 2009, payers and providers across USA have to started to speed up remediation efforts to replace the ICD-9--CM code within their systems with ICD-10-CM and ICD-10-PCS codes by October 1st 2013.