Trial Site Regulatory eBinders

/Trial Site Regulatory eBinders
7 08, 2018

Ten Must-Have Capabilities When Evaluating eRegulatory Platforms

2019-08-02T15:54:39-04:00

Successfully transitioning your team to an eRegulatory solution, while avoiding costly compliance mistakes and realizing true time-saving benefits, requires careful evaluation of potential platforms. After helping thousands of research teams implement eRegulatory, our team has put together these ten essential capabilities to look for when evaluating solutions. You can download our full Guide to Selecting [...]

Ten Must-Have Capabilities When Evaluating eRegulatory Platforms2019-08-02T15:54:39-04:00
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
13 06, 2018

Top 5 Trial Site FDA Inspection Failures, And How to Avoid Them

2019-08-02T15:56:47-04:00

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. [...]

Top 5 Trial Site FDA Inspection Failures, And How to Avoid Them2019-08-02T15:56:47-04:00
7 02, 2018

Innovations | The time is now for eRegulatory and eSource

2019-08-02T16:05:10-04:00

Innovation matters in Clinical Research… The adoption of new technology, in any industry, follows a familiar cycle outlined by Geoffrey Moore in his book Crossing the Chasm, Innovators: Innovators are the first individuals to adopt an innovation. These individuals/teams are willing to take a risk to help advance a solution. Early Adopters: These are the [...]

Innovations | The time is now for eRegulatory and eSource2019-08-02T16:05:10-04:00
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
27 04, 2017

eClinical tools to dClinical tools

2019-08-02T16:08:35-04:00

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 [...]

eClinical tools to dClinical tools2019-08-02T16:08:35-04:00
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
19 12, 2016

What if I get audited?

2019-08-02T16:09:42-04:00

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 [...]

What if I get audited?2019-08-02T16:09:42-04:00
1 10, 2016

My clinical trial monitors say they don’t want an electronic binder. What do I do?

2019-08-01T15:07:01-04:00

The transition to electronic clinical trial binders (eBinders or investigator site files) is underway across the clinical research industry.  eBinders provide several advantages for your site. Well-understood benefits include: Improved compliance. Digital binders allow you to easily track and fix compliance issues so that your site is always audit-ready - no paper sticky notes [...]

My clinical trial monitors say they don’t want an electronic binder. What do I do?2019-08-01T15:07:01-04:00
15 09, 2016

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

2019-08-01T15:06:14-04:00

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 [...]

Before and After the Cloud — A Day in the Life of a Research Coordinator2019-08-01T15:06:14-04:00