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About Mike Kassin

As a physician leader, Mike brings medical expertise focusing on clinical workflows. For fun, he listens to a ton of audiobooks on medicine, commerce, and biographies. Trained at Emory University, Medical Degree from Emory School of Medicine, BS in Biochemistry and Molecular Biology with Minor in Leadership from University of Georgia
6 10, 2016

4 Takeaways from the 4th Annual Embracing Change Conference for Clinical Research

2017-06-11T17:36:51+00:00

The 4th Annual Embracing Change Conference for Clinical Research was a well-produced event from Arizona State University’s Clinical Research Management program. If you did not make it and would like a copy of the Status of Paperless Trials Presentation, send Florence a short email by clicking here.   A substantial portion of the conference revolved [...]

16 06, 2016

Leading Prostate Cancer Research Organization Partners with Florence

2017-06-11T17:36:51+00:00

PCCTC Collaborates with Florence Healthcare to Enhance Regulatory Document Management Capabilities ATLANTA, GA and NEW YORK, June 10, 2016 – Florence Healthcare, developer of the innovative trial site-focused electronic trial site and master file (eTMF) platform, eBinder Suite™, and the Prostate Cancer Clinical Trials Consortium (PCCTC), the nation’s leading multicenter clinical research organization specializing in [...]

13 05, 2016

eSource and eCTD Guidance & Eliminating Shadow Charts: Is Now the Time?

2016-06-23T10:57:29+00:00

Shadow charts develop for various reasons in clinical research as discussed in a prior post on shadow charts.  They emerge at trial sites because of disparate IT systems: for example an EHR record may be printed onto paper for editing, redacting and signing before being rescanned into a study portal. The remaining stub is a [...]

24 03, 2016

Interview Series: Paperless Clinical Trials

2016-04-28T15:29:04+00:00

The views expressed in the interview are solely of the individuals involved and do not represent the views of the associated organization. Interviewer: Mike Kassin, MD, Florence Healthcare Learn more about paperless trials today. Speaker: John McAdams, Manager, Data and Safety Monitoring, UCSF Helen Diller Family Comprehensive Cancer Center ___________ With increasing site workload and protocol complexities, [...]

31 08, 2015

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

2016-05-09T12:40:47+00:00

On June 11, 2015, the International Conference on Harmonization released the draft update of Good Clinical Practice guidelines.  The addenda feature important changes affecting investigator oversight, document processes, monitoring plans, and validation (the changes will not be final until November of 2016).  Each of these pulls the tide towards further electronic management of clinical trials. With R2, [...]

3 08, 2015

Opposing Views on FDA Complete Response Letters

2016-05-09T17:24:12+00:00

Recently, the British Medical Journal published an analysis on how pharmaceutical companies publicly address Complete Response Letters (CRL) from the FDA, more specifically from the Center for Drug Evaluation and Research (CDER). While the EMA publishes data from refusal assessment reports, the FDA does not fully disclose information with CRLs because of privacy rules around unapproved applications. [...]

10 02, 2015

A Doctor’s Signature

2017-06-11T17:36:53+00:00

Ask any pharmacist about the quality of a doctor’s signature and you will hear horror stories about the scribble that is every doctor’s signature. Doctors' signatures are always so hard to read. The signature represents the doctor giving their approval to a plan of care. This signature of approval represents the years of studying and [...]