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The phase in clinical research, which leads to the generation of high-quality, error-free, statistically sound data derived from clinical trials, is termed as clinical data management (CDM). The CDM team is responsible for keeping track of all the processes involved in clinical trials- from inception to completion.

 In order to reach to a high-quality, error-free clinical trial, and reliable analysis, the CDM team usually adopts software applications that maintain audit trail and provide easy identification and resolution of data discrepancies. These software tools that are used for data management are referred to as Clinical Data Management Systems (CDMS). CDMS enables handling of huge amount of data. The CDM tools that are most commonly used are ORACLE CLINICAL, CLINTRIAL, MACRO, RAVE, and eClinical Suite. Functionally, these tools are in no way superior to each other. Also, custom-made CDM tools like OpenClinica, openCDMS, TrialDB and PhOSCo are used by giant multinational pharmaceuticals depending upon their operational and procedural needs.

As a clinical trial is designed to answer a research question, the CDM process is designed to deliver an error-free database. To reach this, the CDM undergoes several processes:

  • Reviewing and finalizing of study documents

  • Database designing

  • Data collection

  • Case report form(CRF) tracking

  • Data entry and validation

  • Discrepancy management

  • Medical coding

  • Database locking

CDM is the result of the increasing demand of the pharmaceutical MNCs to speed-up the drug development process. Maintaining a balance between the expectations and constraints in the existing system, CDM is becoming a standard clinical research entity. 

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