clinical trials

/clinical trials
14 07, 2017

5 Ways To Engage Clinical Trial Sites With Technology

2017-07-14T15:43:32+00:00

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 issues [...]

5 Ways To Engage Clinical Trial Sites With Technology 2017-07-14T15:43:32+00:00
30 03, 2017

Can I control access with electronic binders?

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

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 to [...]

Can I control access with electronic binders? 2017-06-11T17:36:51+00:00
6 10, 2016

4 Takeaways from the 4th Annual Embracing Change Conference for Clinical Research

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

The 4th Annual Embracing Change Conference for Clinical Research was a well-produced event from Arizona State University’s Clinical Research Management program. If you did not make it and would like a copy of the Status of Paperless Trials Presentation, send Florence a short email by clicking here.   A substantial portion of the conference revolved [...]

4 Takeaways from the 4th Annual Embracing Change Conference for Clinical Research 2017-06-11T17:36:51+00:00
15 09, 2016

Before and After the Cloud — A Day in the Life of a Research Coordinator

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

Clinical research coordinators (CRCs) play a crucial role in ensuring the success of research sites. Managing a myriad of responsibilities throughout the day, the CRC is the “heart” of a clinical trial – the champion of the protocol, the guardian of the patients, the taskmaster of the research team. CRCs are charged with ensuring high [...]

Before and After the Cloud — A Day in the Life of a Research Coordinator 2017-06-11T17:36:51+00:00
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 [...]

Defining eSource for Clinical Trials: Three Practical Categories 2017-06-11T17:36:51+00:00
16 06, 2016

Leading Prostate Cancer Research Organization Partners with Florence

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

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 in [...]

Leading Prostate Cancer Research Organization Partners with Florence 2017-06-11T17:36:51+00:00
13 05, 2016

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

2016-06-23T10:57:29+00:00

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 a [...]

eSource and eCTD Guidance & Eliminating Shadow Charts: Is Now the Time? 2016-06-23T10:57:29+00:00
24 03, 2016

Interview Series: Paperless Clinical Trials

2016-04-28T15:29:04+00:00

The views expressed in the interview are solely of the individuals involved and do not represent the views of the associated organization. Interviewer: Mike Kassin, MD, Florence Healthcare Learn more about paperless trials today. Speaker: John McAdams, Manager, Data and Safety Monitoring, UCSF Helen Diller Family Comprehensive Cancer Center ___________ With increasing site workload and protocol complexities, [...]

Interview Series: Paperless Clinical Trials 2016-04-28T15:29:04+00:00
28 01, 2016

Be Audit Ready Now

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

The phrase “Audit Ready” is casually tossed around as a standard practice for both sites and sponsors. When I worked as a research coordinator I went to great lengths to make sure my binders were audit ready, particularly for one study that was deemed a high risk for inspection due to the novel nature of the product [...]

Be Audit Ready Now 2017-06-11T17:36:53+00:00
19 01, 2016

Secure Your Records. Protect Your Research.

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

With banking, stock trading, and now health records becoming electronic, what’s stopping someone from obtaining every detail about our lives? In clinical research, keeping Protected Health Information (PHI) – patients’ personal and identifiable information — secure is the key concern. Losing this means potentially harming the patient, running afoul of laws like HIPAA, and [...]

Secure Your Records. Protect Your Research. 2017-06-11T17:36:53+00:00