Jakob Juul Rasmussen: Zero cost technology - transforming how smaller companies oversee their assets

Send us Fan MailSam 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 RasmussenNotesGuest 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 mentionedQuality Management System (QMS)Electronic Trial Master File (eTMF)Electronic Case Report Form (eCRF)Regulatory Information Management System (RIMS)BoxDropboxSharePointTeamsWord Electronic Signature Functions mentionedCROs  ITAbbreviations & DefinitionseCRF: Electronic Case Report FormeTMF: Electronic Trial Master FileEDC: Electronic Data CaptureFDA: Food and Drug Administration QMS: Quality Management SystemRIMS: Regulatory Information Management System 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 RosendalJoin the conversation on our LinkedIn pageVisit www.labtolives.com HostsAlexander Booth aka the MedTech GuyDimitri Borisevich aka the start-up GuyIvanna Rosendal aka the R&D pharma Gal