Security and Compliance
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SOLUTION SHEET Security and Compliance How Medrio Keeps Your Data Safe We frequently engage with external auditors to ensure we’ve followed all of the necessary software and procedural controls. When joining Medrio, you can be confident that your data is secure and your participants’ privacy is protected. With the regulatory landscape constantly shifting, how do you keep up with all the changes? Staying informed of all the changes and adjusting your operations to adhere to them is incredibly time consuming but that’s where we come in to help. Our experts stay on top of regulatory guidelines, compliance standards, and system security so you can stay focused on your patients and trials. At Medrio, we not only understand that the success of your trial is highly dependent on regulatory compliance but we also are committed to easing this burden for your team. One way we do this is by ensuring our systems always comply with regulations in all the various countries and regions in which our clients operate. We continually perform an in-depth analysis of regulations across the globe and work with external auditors so you can be assured our solutions are complia

FDA Guidance The last thing you need is to reach the final stages of a trial only to discover you have a FDA hiccup. To ensure you can conduct your clinical investigations without the worry of regulatory compliance issues, we fully embrace the following FDA Guidance documents: Compliance Standards Guidance for Industry, Electronic Source Data in Clinical Investigations 7 eneral Data Protection G Guidance for Industry on Computerized Systems Used in Clinical Investigations ICH Guidance for Industry, E6 Good Clinical Practice 7 ICH Good Clinical Practice (GCP) 7 FDA 21 CFR Part 11 Compliance...