Listen "Adam Walker: Transformation in clinical data sources "
Episode Synopsis
Send us a textSam 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 NotesGuest 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-practiceCPRD: 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 mentionedCTMSeProeDiaryRWE/ RWDAI/ MLEHREDCWearablesSmartphones ZoomFunctions mentionedStatistical Programming Data Management BiometricsAbbreviations & DefinitionsAI: Artificial IntelligenceCDISC: Clinical Data International Standards Consortium CTMS: Clinical Trial Management SystemCPRD: Clinical Practice Research DatalinkEDC: Electronic Data CaptureeDiary: Electronic Diary EHR: Electronic Health RecordsePRO: Electronic Patient Recorded OutcomesFDA: Food and Drug Administration GCP: Good Clinical PracticeICH: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human UseMHRA: Medicines and Healthcare Products Regulatory Agency ML: Machine LearningNHS: National Health ServiceRWD: Real-world DataRWE: Real-world Evidence Support the show________Reach out to Ivanna RosendalJoin the conversation on our LinkedIn page
ZARZA We are Zarza, the prestigious firm behind major projects in information technology.