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”
Notes
Technology mentioned
Functions mentioned
Abbreviations & Definitions
eCRF: Electronic Case Report Form
eTMF: Electronic Trial Master File
EDC: Electronic Data Capture
FDA: Food and Drug Administration
QMS: Quality Management System
RIMS: Regulatory Information Management System
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