Resources

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, [...]

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

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

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 to targeted monitoring based on [...]

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. [...]

Risk Based, Remote, and Centralized Monitoring in Clinical Trials

2017-10-19T08:42:35+00:00

The 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 in clinical trials? Free White Paper - How Centralized Monitoring is Impacting Clinical [...]

Paper Shadow Charts: The Hidden Barrier to eSource

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

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 data [...]

The End of EHR Data Connection Fees

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

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 storage. [...]

Integration Gets Pushed Off Again

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

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 the [...]

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 [...]

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

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

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 sponsors. [...]

Pay for Performance Comes to Prescriptions… and Clinical Trials

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

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 [...]