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31 08, 2015

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

2021-05-19T13:30:14-04:00

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 [...]

Moving to Electronic Source: What’s in the June 2015 ICH Guidelines?2021-05-19T13:30:14-04:00
9 08, 2015

Making Risk Based Monitoring Real for the Other 50% of Sponsors

2021-05-19T13:20:53-04:00

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 in very different ways. We encountered three main RBM positions: Source: Florence HC industry interviews, 2015 Targeted. 50% have moved [...]

Making Risk Based Monitoring Real for the Other 50% of Sponsors2021-05-19T13:20:53-04:00
3 08, 2015

Opposing Views on FDA Complete Response Letters

2021-05-19T13:13:10-04:00

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 [...]

Opposing Views on FDA Complete Response Letters2021-05-19T13:13:10-04:00
26 05, 2015

Risk Based, Remote, and Centralized Monitoring in Clinical Trials

2021-05-19T13:04:30-04:00

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 that monitoring queries have on sites. In our session and throughout the conference we heard the question: What is the difference between Risk-Based, Remote-Based, and Centralized Monitoring [...]

Risk Based, Remote, and Centralized Monitoring in Clinical Trials2021-05-19T13:04:30-04:00
21 05, 2015

Paper Shadow Charts: The Hidden Barrier to eSource

2021-05-19T12:52:19-04:00

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 and monitoring requirements, and easier query resolution. With clinical EHR adoption nearing 90%, digital [...]

Paper Shadow Charts: The Hidden Barrier to eSource2021-05-19T12:52:19-04:00
12 04, 2015

The End of EHR Data Connection Fees

2021-05-19T12:46:55-04:00

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. What has changed is what happens to this data logistically and economically after the patient visit. First, a bloom of EHRs drove digital [...]

The End of EHR Data Connection Fees2021-05-19T12:46:55-04:00
3 03, 2015

Integration Gets Pushed Off Again

2020-08-25T16:04:52-04:00

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 of patents' information. We propose there’s another way — an approach that puts the clinician in control of data movement. First let’s look at [...]

Integration Gets Pushed Off Again2020-08-25T16:04:52-04:00
10 02, 2015

A Doctor’s Signature

2021-05-19T12:39:25-04:00

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 [...]

A Doctor’s Signature2021-05-19T12:39:25-04:00
1 02, 2015

Clinical Trial Data Sharing: Has the IOM Taken on Too Big a Challenge?

2020-08-25T16:04:00-04:00

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 of therapy development is clear. How does this work? Collectively, sharing trial data would reduce cost and data leakage by eliminating duplicate efforts for [...]

Clinical Trial Data Sharing: Has the IOM Taken on Too Big a Challenge?2020-08-25T16:04:00-04:00
22 01, 2015

Pay for Performance Comes to Prescriptions… and Clinical Trials

2020-08-25T16:01:47-04:00

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 practitioners, but surprisingly, also for therapy development. First, a little background. Pay-for-performance incentivizes providers with bonus payments as well as with [...]

Pay for Performance Comes to Prescriptions… and Clinical Trials2020-08-25T16:01:47-04:00
15 01, 2015

Do good, feel good: make software that matters

2021-05-19T12:29:14-04:00

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, social media’s impact is estimated to top $1.3 trillion annually. That’s a big number, and if you’re a software developer, its one that will get you featured on Techcrunch, and get you lauded [...]

Do good, feel good: make software that matters2021-05-19T12:29:14-04:00
2 01, 2015

FlorenceHC 2015 Meta List

2022-10-31T11:35:31-04:00

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 Year! – The Florence Healthcare Team, makers of eBinders for sites and eBinders for sponsors. The ’15 [...]

FlorenceHC 2015 Meta List2022-10-31T11:35:31-04:00
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