Clinical Data Management: an Understanding

The data generated by clinical trials serves as a critical raw material for clinical studies and the subsequent development of drugs or other medical products. This input, called clinical data, is very valuable in helping pharmaceutical, life sciences and medical device companies innovate and produce new products.

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This data is invaluable for companies that are involved in the development of new products. This data is the crucial ingredient that helps in formulating new therapies and treatments and help take these into the market. So, organizing and managing these data to help companies put these data to their intended use is a major responsibility for companies that are in the process of developing new products.

Clinical Data Management (CDM) is the science of documentation, preservation and management of data that clinical trials throw up. CDM covers the entire range of activities from collection of data to its analysis. CDM has come a long way from being a drab and clerical function in the 1970’s and 80’s to something that companies actively look forward to and invest considerably into.

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The main impetus for this evolution can be attributed to automation. Today, CDM is a full-fledged discipline that generates many jobs and careers, and is being actively regulated by the regulatory agencies.

Comprehensive learning about CDM

  • Data Management Plan, or DMP
  • Study startup activities
  • Study conduct activities
  • Study closeout
  • Study monitoring.

Learning outcomes

This seminar on Clinical Data Management will help participants gain complete knowledge of the crucial aspects of CDM. Following the learning gained over these two days, they will be able to define best practices as they apply to CDM processes, describe CDM processes from study start-up to database lock, apply best practice rationale when assessing data collection requirements/instruments, evaluate the benefits of standardization in establishing CDM processes, and discuss current technology/methods of data collection and associated documentation.