Part 1: Lack of Oversight Discussion of FDA inspections, whether for cause or part of a routine GCP inspection, usually centers on the inspection of trial sites and the CROs who are tasked with managing them. The reason for the disproportionate focus on the inspection of trial sites and CROs stems from two material [...]
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So far Blake Adams has created 19 blog entries.
Over the last six months something interesting happened in usage data for eBinders, Florence’s eRegualtory and eSource platform, and by extension for study management in general. In April 2018 Clinical Research Associate (CRA) teams became Florence’s most active users. In fact, sponsor activity in the tool grew by nearly ten times Q4 2017 to Q1 2018. [...]
Recorded Webinar: Avoiding Digital Site Surprises Odds are that your CRA team is already logging into electronic investigator site files at some of your sites. Now what? View this on-demand webinar to learn how leading sponsors and CROs are taking advantage of digital platforms at trial sites. We explore the how your [...]
Your heart begins beating faster and sweat begins forming on your forehead - the FDA is calling. Many things can trigger an FDA inspection - most falling into routine study-related visits, while some are "for cause," stemming from complaints or sponsor concerns. Sites that have a new drug application will most likely experience an FDA inspection. [...]
On-Demand Webinar: Surviving an FDA Inspection with eRegulatory In this recorded webinar our panel of experts from Florence and LMK Clinical Research discuss how an FDA inspection works with eRegulatory, what the FDA is looking for, and how to prepare your site for a successful inspection.
While helping over 2,000 research teams migrate Florence eBinders for eRegulatory, we've encountered people who have become "superheroes" in managing the workflow of regulatory and source documents at their site. In working closely with them to take what they are doing now and move it to a streamlined digital workflow, we've identified ten types of these "superheroes" and [...]
Webinar: Solving Clinical Trial Inefficiencies with eRegulatory In this on-demand webinar our team examines how leading clinical trial sites are solving clinical trial operation inefficiencies with eRegulatory. Introducing eRegulatory into clinical trial trials is proving to deliver real operational improvements with a measurable impact on efficiency for thousands of trial sites. [...]
WASHINGTON, April 26, 2018 (Newswire.com) - Leading up to the Association of Clinical Research Professionals Annual Meeting in Washington D.C., Florence announced over 2,000 clinical trial teams are now actively managing the eRegulatory and eSource for 600+ Pharmaceutical and Medical Device studies in its eBinders solution. Founded in 2015, Florence partnered with innovative clinical trial sites with the [...]