Is site submission quality less important than data analysis?

Clinical trial sponsors have focused for years on finding the right investigators who can recruit patients, and choosing the best core laboratories to do the necessary data analysis. Without a doubt, having the best thought leaders associated with a trial can increase the level of success (defined as pursuing the right path and abandoning the […]

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Patient privacy regulations and Part 11: How do they relate?

In the world of clinical trials, we are constantly reminded of national privacy regulations and 21 CFR Part 11 restrictions when using electronic means to submit medical imaging data. National regulations (NRs) include the European Union Directive on Data Privacy, The Canadian Personal Information Protection and Electronic Documents Act (PIPEDA), HIPAA, OECD and their equivalents […]

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Cloud infrastructure in imaging trials: the need for quality

In an interesting interview in Bio.IT World, Glen DeVries, president of Medidata Solutions, spoke about the evolution of clinical trial processes and how we’re inevitably going toward cloud solutions. I couldn’t agree more. As Glen points out, we’ve seen this phenomenon across a multitude of industries: The advent of good software packages moved things from […]

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Moving from media to electronic submissions: Five tips every clinical PM should know

An Operations Project Manager at AG Mednet oversees the customization and deployment of AG Mednet’s exam processing and submission technology to its core lab and pharmaceutical/device customers. The set-up of AG Mednet software for an imaging clinical trial begins with a requirements-gathering process for the application build. The Project Manager works with the Operations Engineers […]

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