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Sam and Ivanna speak Adam Walker about the transformation in clinical data from his experience with CROs, sites and sponsors. Adam takes us through how clinical data collection has evolved from paper forms, to being collected digitally and now fully integrated with patients’ existing devices. This shift increases the volume of data available, the quality of the data, but also puts additional pressure on the industry to make sense of the data in real time. Adam makes the point that technology companies have an advantage in identifying the value of the information collected - not only for treatment, but also to support preemptive lifestyle choices. His advice for anyone working in this field is to “not take the comfy chair” of how we used to do things. 

“The data has not changed, but how we collect it has changed” 

• Adam Walker 

Notes

• Guest Adam Walker: https://www.linkedin.com/in/adam-walker-2327951/ 
• 21st Century Cures Act: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act  
• The 100 Year Life by Lynda Gratton and Andrew J Scott: https://www.100yearlife.com/ 
• Declaration of Helsinki: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ 
• ICH: https://www.ich.org/
• GCP: https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-clinical-practice
• CPRD: https://www.cprd.com/
• CDISC: https://www.cdisc.org/ 
• Clinical Trials overview: https://www.clinicaltrials.gov/ 
• Huxley Morton Podcast: https://www.huxleymorton.com/podcast.php 

Technology mentioned

• CTMS
• ePro
• eDiary
• RWE/ RWD
• AI/ ML
• EHR
• EDC
• Wearables
• Smartphones 
• Zoom

Functions mentioned

• Statistical Programming 
• Data Management 
• Biometrics

Abbreviations & D

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Hosts

Alexander Booth aka the MedTech Guy

Dimitri Borisevich aka the start-up Guy

Ivanna Rosendal aka the R&D pharma Gal

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Sam and Ivanna speak to Angela Slocum about the difficulty in quantifying the benefits of risk based monitoring when mostly you find no issues in your data. Angela does share an example of a fraudulent site being uncovered through risk based monitoring. We speak about how having experience from multiple clinical functions enables a unique platform for innovation when new demands arise but also when implementing software in the clinical space. We also dwell on managing change in our industry, and how conquering fear is vital even when working with highly skilled experts.   

“The science is so much more sophisticated than it used to be. There is much more data than there used to be. The data types and the amount of data are vast. And the roles and skills needed to support all that have evolved” 

• Angela Slocum 
  
  

Notes

Guest Angela Slocum: https://www.linkedin.com/in/angela-slocum-160b48126/ 

Risk-based monitoring (TransCelerate): https://www.transceleratebiopharmainc.com/rbminteractiveguide/what-is-risk-based-monitoring-rbm/introduction/ 

Technology mentioned: 

• SAS 
• JReview 
• Spotfire 
• EDC
• AI/ ML
• elluminate

Functions mentioned: 

• Statistical Programming 
• Data Management 
• Clinical Operations 
• Analytics 
  
  

Visit Labtolives.com

Do you want to try the quiz from this episode? Find the link on our LinkedIn profile: https://www.linkedin.com/company/labtolives/ 

Would you like to join the show as a guest or collaborator? Find out how on our website: https://www.labtolives.com/ 

Support the show

________
Reach out to Ivanna Rosendal

Join the conversation on our LinkedIn page

Visit www.labtolives.com 

Hosts

Alexander Booth aka the MedTech Guy

Dimitri Borisevich aka the start-up Guy

Ivanna Rosendal aka the R&D pharma Gal