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27 04, 2017

eClinical tools to dClinical tools

2017-07-14T15:44:35+00:00

Gartner’s Michael Shanler was one of the first to recognize the trend of dClinical. He noticed that a new generation of software vendors was emerging who handled project management and reporting in a new way. Florence agrees with Michael’s observation, which is why we’re building tools that align with a dClinical approach. An abbreviated history [...]

6 03, 2017

Florence Nominated to Present at 2017 Montgomery Summit

2017-07-14T15:46:06+00:00

Florence, the company advancing clinical research through software, will be presenting at the 2017 Montgomery Summit this week in Santa Monica California. The Montgomery Summit chose Florence to present from a field of over 4,000 applicants. Presenters represent the most impressive and innovative companies in their fields, including enterprise software, cloud infrastructure, cybersecurity, marketing and [...]

24 02, 2017

What’s Your eRegulatory Strategy?

2017-06-11T17:36:51+00:00

What’s your eRegulatory Strategy? In the last year we’ve met with dozens of research centers to discuss this question. We discovered that moving to an eRegulatory platform is much more than moving from paper to digital documents. Formulating a site-wide strategy for eRegulatory means considering 1) the benefits you seek and 2) the transition costs [...]

19 12, 2016

What if I get audited?

2017-07-14T15:45:24+00:00

A common question many teams ask as they face the transition to digital study documents is, “What if I get audited?” Inspections evoke fear because negative audit findings significantly impact everyone. Areas of high risk include missing documents, accurate delegation of authority logs, reporting delays, and inadequate monitoring or PI oversight. Given these risks, some [...]

15 12, 2016

“My PIs are super busy and unable to try new things! How can I convince them to try eBinders?”

2016-12-15T14:13:29+00:00

Research protocol complexity is increasing and trial volumes are growing. The result - sites are struggling to take on more with the same team. Physicians and research teams are overwhelmed with cumbersome documentation and oversight requirements spread out across multiple locations. Workload imbalance and audit risk anxiety has led to turnover – exacerbating the problem. [...]

12 07, 2016

Defining eSource for Clinical Trials: Three Practical Categories

2017-06-11T17:36:51+00:00

When discussing eSource there is as much detail to explore as any other segment of clinical trial operations. But from small biotechs to top 20 pharma, the starting point for discussions is more simple: how do we define eSource? After numerous deployments of eBinders and eBinders eSource, we've come to understand that eSource is three things. First, let's set [...]

23 04, 2016

Florence Trial Site eBinder Usage Grows Over 560% in March

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

Florence becomes industry’s fastest-growing eBinder tool with 6x usage growth in one month; welcomes major centers as customers. Association for Clinical Research Professionals (ACRP) Conference—The pharmaceutical industry spends roughly $35 billion a year on clinical drug trials to test new therapies. About a third of that amount — $10 billion — is spent on monitoring [...]

28 02, 2016

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

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

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, monitoring [...]

9 08, 2015

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 [...]

21 05, 2015

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 [...]