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Sam and Ivanna speak to Jakob Juul Rasmussen about the stubborn prevalence of paper in clinical trials, especially in small pharmaceutical and biotech companies. Paying money up front, covering the implementation and license costs and building up internal IT functions can be prohibitive for small pharmaceutical and biotech companies. This leads many companies to outsource their entire IT landscape to CROs. As a result, control over assets becomes complicated and cumbersome, as your clinical data risks being stored in different applications with multiple data models applied.  Standard configuration is helping bridge the gap, but compliance requirements from authorities for both internal and CRO-maintained software are unchanged. Jakob suggests a radical third way of getting the set of applications needed to run the business of any biotech or pharmaceutical company, without resorting to paper or complete outsourcing, transforming both how technology companies deliver IT solutions and how IT is anchored with the sponsor companies. 

“Small companies really want to focus on science and just have the necessary tools to provide the best science”

• Jakob Juul Rasmussen

Notes

• Guest Jakob Juul Rasmussen : https://www.linkedin.com/in/jakobjuulrasmussen/ 
• PharmaIT: https://pharmait.dk/ 
• ISPE GAMP 5 https://ispe.org/publications/guidance-documents/gamp-5 
• ALCOA ++ https://www.gmp-compliance.org/gmp-news/alcoa-what-does-it-mean 
• Pharmacovigilance Signal Detection: https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/signal-management 
• EMA Notice to Sponsors on Validation and Qualification of Computerized Systems used for Clinical Trials: ​​https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/notice-sponsors-validation-qualification-computerised-systems-used-clinical-trials_en.pdfhttps://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/notice-sponsors-validation-qualification-computerised-systems-used-clinical-trials_en.pdf 
• DIA Reference models: https://www.diaglobal.org/en/resources/tools-and-downloads 

Technology mentioned

• Quality Management System (QMS)
• Electronic Trial Master File (eTMF)
• Electronic Case Report Form (eCRF)
• Regulatory Information Management System (RIMS)
• Box
• Dropbox
• SharePoint
• Teams
• Word 
• Electronic Signature 

Functions mentioned

• CROs 
•  IT

Abbreviations & Definitions

eCRF: Electronic Case Report Form

eTMF: Electronic Trial Master File

EDC: Electronic Data Capture

FDA: Food and Drug Adminis

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