Updates from the Board – July 2019

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In Association news

As we celebrate our 25th anniversary, we recognize that times they are a-changin for SCDM and Data Management as we know it!

The latest ‘SCDM reflection paper evolution to clinical data science’ talks all about the evolution of the Clinical Data Management role and describes the new and refined skillsets needed.

Below are some highlights from the paper that reflect the need for the changing role in Data Management.  There is much more detail in the paper available for download by all.

Drivers of change and their impact on CDM:

  • Adaptive study design
  • Study designs to accommodate multiple investigational products and/or indications
  • Study design leveraging Synthetic Arms
  • Decentralized Clinical Trials
  • Impact of emerging study designs on Clinical Data Management

Impact of regulations on Data Quality and CDM Practices:

  • Data Quality
  • RBM
  • Data Analytics
  • Global and Local regulations
  • Reduction of EDC Centricity – data coming from many sources
  • AI
  • ML
  • Blockchain
  • Sensors and Wearables

Also from the paper: Our mission is to set a roadmap toward Clinical Data Science which requires the evolution of our skillsets, processes, technologies and best practices. In this data and patient centric framework, CDM will play a strategic role in ensuring the reliability of the trial results and support the transformation that Clinical Research needs.

Did you notice that there is now a data management related article published in our Data Connections newsletter?  This newsletter is available to all ‘Friends of SCDM’ for free.  The May 2019 newsletter contains: ‘GAZING AT THE CRYSTAL BALL, WHERE DO YOU SEE YOURSELF IN THE NEXT 5 YEARS? I SEE A GREAT DATA MANAGER AND I SEE MORE…’ by Hui (Tanya) Sun.  We hope our friends that see the articles in this newsletter convert to a full member.  Full members receive SCDM’s Data Basics. Data Basics is a quarterly digital journal, featuring peer-reviewed articles on industry news and issues for members only.

Hopefully by now, you’ve seen the new mission and vision of SCDM.  SCDM has a new mission and vision that reflect the exciting changes we are seeing in the industry. Our new mission ‘Leading innovative clinical data science to advance global health research and development’ defines how SCDM will play a role in this change, and the Vision: ‘Connect and inspire professionals managing global health data with global education, certification and advocacy’ details how we are going to lead these changes.

SCDM is leading this revolutionary change in our industry and we want you to participate and enjoy the ride.  Please consider volunteering for one of our many committees.  Participating in a committee will put you in the forefront of leading the Clinical Data Community.

 

Jennifer Price

Secretary, SCDM

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