Michael Kassin

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Health IT

Moving to Electronic Source: What’s in the June 2015 ICH Guidelines?

On June 11, 2015, the International Conference on Harmonization released the draft update of Good Clinical Practice guidelines.  The proposed R2 addendums are a significant update and feature important addendums affecting investigator oversight, document processes, monitoring plans, and validation. (The changes will not be final until November of 2016.).  All these pull the tide towards further electronic […]

Health IT

Opposing Views on FDA Complete Response Letters

Recently, the British Medical Journal published analysis on how pharmaceutical companies publicly address Complete Response Letters (CRL) from the FDA, specifically the center for drug evaluation and research (CEDR). While the EMA publishes data from refusal assessment reports, the FDA does not fully disclose information with Complete Response Letters because of privacy rules around unapproved applications. […]

Health IT

Paper Shadow Charts: Hidden Barrier to eSource in Risk Based Monitoring

The benefits of eSource, where trial data remains electronic from start through data lock, are well understood. They include the elimination of transcription errors (shown by Nham et al to be 10x more accurate), reduction in duplicitous effort, reduced monitoring requirements and easier query resolution. With clinic EHR adoption nearing 90%, digital datapoints should be […]

Health IT

Tracking Three Phases of Maturity for the Wearable Device Marketplace

According to Florence Healthcare’s wearablesandapps.com, a database surveying 85 connected devices, the majority of wearable health devices are focused on activity tracking. But with wearables now supporting almost 31 different measurements, companies making heart rate, blood pressure, glucose, and temperature devices are pushing vital metrics into the sphere of diagnostic care.   According to the […]