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...
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We’ve hit “Peak EHR,” now what?
Today electronic health records are now entrenched in the care experience after a painful adoption cycle. In fact, the last ten years were the decade of EHR adoption, with penetration growing from 17%...
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What’s really happening with Risk Based Monitoring and trial sites?
Is Risk Based Monitoring a help? Depends on where you sit in the clinical trial process. For example, in a recent Wall Street report, a CRO boasts: “20,000 sites and 250,000 patients now remotely...
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How will healthcare adopt “Event Driven” medicine?
Pairing remote monitoring devices with event driven medicine algorithms has the potential to address home health care’s current reliability and usability limitations. Studies have shown that home...
View ArticleFlorenceHC 2015 Meta List
To launch 2015, here’s a New Year’s greeting we hope is actually helpful: We’ve curated 15 of the best market intel sites in health IT to prepare you to take on the year. Happy reading and Happy New...
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Do good, feel good: make software that matters
Today, the largest technology companies in the world create social connections, organize the world’s information, and build great devices. These have a massive impact on society. According to McKinsey,...
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Pay for Performance Comes to Prescriptions… and Clinical Trials
Payers are changing how providers get paid — from fee for service to paying for performance. This transition will be at the center of healthcare change for the foreseeable future– not only for...
View ArticleClinical Trial Data Sharing: Has the IOM Taken on Too Big a Challenge?
In January of 2015, the Institute of Medicine (IOM) made an historic call to increase the sharing of data gathered in clinical trials. The aim to increase knowledge and subsequently increase the rate...
View ArticleA Doctor’s Signature
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...
View ArticleIntegration Gets Pushed Off Again
HL7, CDA, FHIR, CDISC, CDASH. The word jumble surfaces when researchers attempt to integrate clinical data with trial data. It also illustrates a trend where technologists, not clinicians, have control...
View ArticleThe End of EHR Data Connection Fees
The basis of healthcare data has not changed. Patient histories still set the stage. The exam still details how the patient looks, feels, and sounds. Vital signs are still gathered in similar ways....
View ArticlePaper Shadow Charts: The Hidden Barrier to eSource
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...
View ArticleRisk Based, Remote, and Centralized Monitoring in Clinical Trials
This Post Originally Published in 2017, Updated in April 2021 AfteThe Florence team just got back from the MAGI conference where we spoke on clinical trial site operational efficiency and the impact...
View ArticleOpposing Views on FDA Complete Response Letters
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...
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Making Risk Based Monitoring Real for the Other 50% of Sponsors
This year we’ve met with 45 pharmaceutical, biotech, and device sponsors about both risk-based and remote-based monitoring (the combination referred to as RBM), and we’re seeing sponsors migrate to RBM...
View ArticleMoving 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 addenda feature important changes affecting investigator oversight,...
View ArticleSecure Your Records. Protect Your Research.
With banking, stock trading, and now health records becoming electronic, what’s stopping someone from obtaining every detail about our lives? In clinical research, keeping Protected Health Information...
View ArticleBe Audit Ready Now
The phrase “Audit Ready” is casually tossed around as a standard practice for both sites and sponsors. When I worked as a research coordinator I went to great lengths to make sure my binders were audit...
View ArticleThe Other Side of EDC and eTMF: A Webinar with SCRS
EDC and eTMF applications streamline data capture for sponsors, but what is the rest of the digital story for sites? How close is the industry really to linking electronic source and moving beyond...
View ArticleInterview Series: Paperless Clinical Trials
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...
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