The Society for Clinical Data Management (SCDM) is delighted to announce the publication of their latest industry whitepaper, “The Evolution of Clinical Data Management to Clinical Data Science.” Drawing on multiple industry perspectives and expert insight, the paper takes a detailed look at new clinical research trends and their impact on clinical data management skills, processes, and technologies.

The paper supports our SCDM Vision of “Leading innovative clinical data science to advance global health research and development”. As such, “Our goal in 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 clinical data management,” noted Patrick Nadolny, Chair of the SCDM Innovation Committee and Global Head of Clinical Data Management and Programming at Allergan. “We want to spark a well-informed discussion in our industry around this important topic.”

Coming as SCDM marks 25 years of industry leadership in clinical data management, the reflection paper offers insight into several rapidly evolving areas critical to the effective collection, analysis, and submission of clinical data, including:

• The impact of the rising complexity of clinical research approaches such as adaptive study design and decentralized clinical trials.

• What a continually shifting regulatory environment means for data quality and clinical data management practices, including definitions of data quality and risk‐based clinical data management.

• How new technologies such as Artificial Intelligence (AI) and wearable are transforming clinical trials leading to the reduction of electronic data capture (EDC) centricity moving forward

• Career considerations for clinical data managers – among them how the role of the clinical data manager is changing, why clinical data management is at the heart of risk‐based study execution, and new skillsets necessary for managing the evolution of clinical data.

“As SCDM celebrates its 25th year, we are proud to provide valuable resources to help the industry effectively manage the next 25 years of clinical data management and clinical data science,” said Linda King, SCDM Chair and Global eCOA Capability Lead at Astellas Pharma. “This paper is the perfect demonstration of SCDM’s mission to connect and inspire professionals managing global health data with global education, certification, and advocacy.”

To continue leading the discussion around the evolution of data management to data science, the SCDM Innovation Committee will release two additional papers in the coming months that expand on key topics from the new reflection paper. The first paper reviewed how technology enables clinical data managers to address new research approaches while remaining compliant with evolving regulations. The second will go into greater detail on the ways CDM’s can evolve their skillsets and utilize technology to effectively manage this industry transformation.

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About the Society for Clinical Data Management

The Society for Clinical Data Management (SCDM) is a non-profit, international organization of 2,200+ members, created to advance the discipline of Clinical Data Management. SCDM’s vision is to lead innovative clinical data science to advance global health research and development; its mission is to connect and inspire professionals managing global health data with global education, certification, and advocacy.

Additional information:
For more on SCDM visit https://www.scdm.org
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