clinical trials

/clinical trials
18 06, 2018

Transitioning your CRA team to Digital Site Management

2018-06-18T11:13:27+00:00

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 Management 2018-06-18T11:13:27+00:00
13 06, 2018

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

2018-06-19T22:31:47+00:00

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 Them 2018-06-19T22:31:47+00:00
27 03, 2018

The Impact of Remote Monitoring on CRAs | Central Monitoring Summit

2018-03-27T21:24:16+00:00

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 Summit 2018-03-27T21:24:16+00:00
19 03, 2018

[Infographic] Launching eSignatures in Clinical Trials while Avoiding Part 11 Risks

2018-06-18T15:25:39+00:00

Electronic signatures, eSignatures, are continuing to gain momentum in the clinical trial landscape. The immediate benefits of eSignatures are clear -  your team can eliminate the printing of most regulatory documents, chasing signers, and scanning and faxing files.However, recent advances in purpose-built solutions employ eSignatures for far more than these basic benefits. Solutions in eRegulatory [...]

[Infographic] Launching eSignatures in Clinical Trials while Avoiding Part 11 Risks 2018-06-18T15:25:39+00:00
12 03, 2018

Cancer Research Is Accelerating, but We Can Do Better

2018-03-12T10:48:40+00:00

The rate of cancer death has been decreasing, and people are living longer with cancer than ever before. Approximately 64% of US patients diagnosed with cancer in 2005 have lived 10 years or more beyond diagnosis, up from 35% for those diagnosed in 1975. — American Society of Clinical Oncology Cancer Advances Report, 2018. [...]

Cancer Research Is Accelerating, but We Can Do Better 2018-03-12T10:48:40+00:00
7 02, 2018

Innovations | The time is now for eRegulatory and eSource

2018-04-06T22:30:42+00:00

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 eSource 2018-04-06T22:30:42+00:00
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