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9 07, 2019

Integrating the eTMF and eISF: Why and Why Now?

2019-08-01T20:42:54-04:00

Electronic Investigator Site Files (eISF) are now attracting the attention of progressive sponsors and CROs. Here, we’ll explore the different approaches and stages for connecting the site eISF directly to the sponsor Electronic Trial Master File (eTMF) and how this adjustment impacts the way clinical trials are conducted. Over the last five years, the [...]

Integrating the eTMF and eISF: Why and Why Now?2019-08-01T20:42:54-04:00
2 07, 2018

Nontransferable Obligations: Why Sponsors Fail Inspections

2019-08-02T15:55:31-04:00

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 [...]

Nontransferable Obligations: Why Sponsors Fail Inspections2019-08-02T15:55:31-04:00
18 06, 2018

Transitioning your CRA team to Digital Site Management

2019-08-02T15:56:04-04:00

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. [...]

Transitioning your CRA team to Digital Site Management2019-08-02T15:56:04-04:00
27 03, 2018

The Impact of Remote Monitoring on CRAs | Central Monitoring Summit

2019-08-02T16:02:50-04:00

While presenting at Central Monitoring Summit 2018, Elizabeth Robinson of Horizon Pharma shared a strong data point: In the coming years, Clinical Research Associates (CRAs) will experience more change to their jobs than any other research profession (2017 Applied Clinical Trials survey). This statement spurred a conversation amongst the room about what will change [...]

The Impact of Remote Monitoring on CRAs | Central Monitoring Summit2019-08-02T16:02:50-04:00
14 07, 2017

5 Ways To Engage Clinical Trial Sites With Technology

2019-08-02T16:08:22-04:00

As Featured in Clinical Leader, July 13 2017 Clinical research has a reputation for being notoriously slow to adopt new technologies. This should come as no surprise to those in the industry, since we operate in a highly regulated environment. We’re generally skeptical about technology for three main reasons: Potential data security and compliance [...]

5 Ways To Engage Clinical Trial Sites With Technology2019-08-02T16:08:22-04:00
30 03, 2017

Can I control access with electronic binders?

2019-08-02T16:08:53-04:00

You’ve decided to make the transition from papers to digital. Your sponsor is on board. You’ve organized your binder and folder structure templates. Now what? It’s time to configure access by setting up roles and permissions. Not sure where to start? Here’s a quick guide to managing your team digitally. Wait, I never had [...]

Can I control access with electronic binders?2019-08-02T16:08:53-04:00
16 06, 2016

Leading Prostate Cancer Research Organization Partners with Florence

2019-08-01T15:05:00-04:00

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 [...]

Leading Prostate Cancer Research Organization Partners with Florence2019-08-01T15:05:00-04:00
13 05, 2016

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

2019-08-01T15:04:34-04:00

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 [...]

eSource and eCTD Guidance & Eliminating Shadow Charts: Is Now the Time?2019-08-01T15:04:34-04:00
28 02, 2016

The Other Side of EDC and eTMF: A Webinar with SCRS

2019-08-01T15:03:46-04:00

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 three-ring regulatory binders? Hear what lies in store for sites in 2016 and how digitization can affect investigator oversight, document processes, [...]

The Other Side of EDC and eTMF: A Webinar with SCRS2019-08-01T15:03:46-04:00