Clinical Data Science

First, Clinical Data Science is not to be confused with the general discipline of Data Science which applies across multiple industries. From an SCDM point of view and as expressed in the third reflection paper, Clinical Data Science is an evolution of Clinical Data Management. Clinical Data Science encompasses processes, domain expertise, technologies, data analytics and Good Clinical Data Management Practices essential to prompt decision making throughout the life cycle of Clinical Research. Clinical Data Science can be defined as the strategic discipline enabling the execution of complex protocol designs in a patient centric, data driven and risk-based approach ensuring subject protection as well as the reliability and credibility of trial results.

In contrast, Clinical Data Management is responsible for the life cycle of clinical data from collection to their delivery for statistical analysis in support of regulatory activities. Clinical Data Management is primarily focusing on dataflows and data integrity (i.e., data is managed the right way). Clinical Data Science broadens this focus by adding the data risk, data meaning and value dimensions for achieving data quality (i.e., data is credible and reliable). Clinical Data Science also expands the scope of Clinical Data Management beyond the study construct by requiring the ability to generate knowledge and insights from clinical data to support other clinical research activities which requires different expertise, approaches, and technologies.

Publications

The Evolution of Clinical Data Management into Clinical Data Science

Part 1: Drivers

A Reflection Paper on the impact of the Clinical Research industry trends on Clinical Data Management

 

The main objective of this paper is to provide a forward‐looking and pragmatic view on why and how emerging study designs, regulations and technology innovations are reshaping the role and profile of CDM.

Part 2: The technology enablers

A Reflection Paper on how technology will enable the evolution of Clinical Data Management into Clinical Data Science

 

This second paper focuses on the technologies enabling our evolution towards Clinical Data Science and allowing us to efficiently manage the 5Vs of clinical data (i.e., Variety, Volume, Velocity, Veracity and Value). It shares insights and lessons learned from leaders, pioneers and early adopters of those emerging technologies.

Part 3: The evolution of the CDM role

A Reflection Paper on the evolution of CDM skillsets and competencies

 

This paper provide insights on how CDM professionals who have successfully and passionately contributed to the credibility of CDM can evolve their skillsets and competencies to cope with the increasing complexities of clinical research which demands novel approaches maximizing the potential of available technologies.

Applied Clinical Trials (March 2020) – The Clinical Data Manager: A Roadmap for the Future

Clinical Leader (September 2020), What Is Your AI Road Map To Revolutionize Drug Development?

Interactive papers

COMING SOON

On September 1st, the SCDM Innovation Committee will release the latest CDS position paper: Evolution toward Clinical Data Science.

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    Meet the authors:

    Authors of the Reflection Papers

    All Authors

    Demetris Zambas

    Vice President and Global Head of Data Monitoring and Management, Pfizer

    All Authors

    Richard Young

    Advocating the need for data management every day

    All Authors

    Josh Wilson

    Executive Director, Strategic Technology Advancement, Biometrics, Syneos Health

    All Authors

    François Torche

    CEO, CluePoints

    All Authors

    Ian Shafer

    Partner, PwC

    All Authors

    Inder Sachdeva

    Portfolio Delivery Lead, Clinical Data Sciences & Safety, Cognizant Technology Solutions

    All Authors

    Patrick Nadolny

    Chair of the SCDM Innovation Committee, Associate Vice President, Clinical Data Management and Programming, Allergan, an AbbVie company

    All Authors

    Cat Hall

    Vice President, Product Strategy, endpoint Clinical

    All Authors

    Catherine Celingant

    Executive Director, Data Monitoring and Management, Pfizer

    All Authors

    Sanjay Bhardwaj

    Exec. Director and Global Head of Clinical Data Management, Allergan, an AbbVie company

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