StudyOrganizer – Your Complimentary Study Management Assistant

12 02, 2019

5 Key Advantages of eRegulatory

2021-05-20T11:37:39-04:00

Over 75% of clinical trial sites who have not yet adopted eRegulatory plan to do so in 2019. Why? In addition to growing industry pressure from sponsors who expect a digital site infrastructure, trial sites with eRegulatory platforms are introducing key advantages over those sites without eReg. What are those advantages? Download Five Key Benefits [...]

5 Key Advantages of eRegulatory2021-05-20T11:37:39-04:00
28 12, 2018

Thank you for a great 2018!

2022-10-31T12:03:41-04:00

What a great year at Florence! As we look back and celebrate all that has happened this year on our mission to advance research, we thank you for being a part of the Florence family. We are excited to share some of our highlights with you. Over 2,500 Research Teams added in 2018! Research [...]

Thank you for a great 2018!2022-10-31T12:03:41-04:00
24 10, 2018

Four Observations from Site Solutions Summit

2021-05-20T10:46:49-04:00

This year’s SCRS Site Solutions Summit was the biggest ever, and for good reason—sites are coming into their own in the clinical trial value chain. Not only are sites maturing their operations and sending more staff to events like SCRS to learn, but sponsors have also realized that connections with sites are more important [...]

Four Observations from Site Solutions Summit2021-05-20T10:46:49-04:00
7 08, 2018

Ten Must-Have Capabilities When Evaluating eRegulatory Platforms

2021-05-20T10:17:46-04:00

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 Platforms2021-05-20T10:17:46-04:00
18 06, 2018

Transitioning Your CRA Team to Digital Site Management

2021-05-20T10:07:45-04:00

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 Management2021-05-20T10:07:45-04:00
13 06, 2018

How to Avoid the Top 5 Clinical Trial FDA Inspection Failures

2021-05-20T10:00:32-04:00

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. [...]

How to Avoid the Top 5 Clinical Trial FDA Inspection Failures2021-05-20T10:00:32-04:00
15 05, 2018

10 Superpowers of Clinical Trial Leaders

2021-07-27T20:20:36-04:00

While helping over 10,000 research teams migrate Florence eBinders for eRegulatory, we've encountered people who have become "superheroes" in managing the workflow of regulatory and source documents at their site. In working closely with them to take what they are doing now and move it to a streamlined digital workflow, we've identified ten types of these "superheroes" [...]

10 Superpowers of Clinical Trial Leaders2021-07-27T20:20:36-04:00
27 03, 2018

The Impact of Remote Monitoring on CRAs | Central Monitoring Summit

2021-05-19T19:08:12-04:00

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 Summit2021-05-19T19:08:12-04:00
19 03, 2018

How to Use Electronic Signatures (eSignatures) in Clinical Trials

2021-05-19T19:00:10-04:00

Electronic signatures, eSignatures, are continuing to gain momentum replacing wet signatures in Clinical Trials. Wet signatures are signatures made by hand on a document, typically with a pen and paper, which are often later electronically scanned into a storage system or maintained on paper and stored in a binder room. Electronic Signatures, often called [...]

How to Use Electronic Signatures (eSignatures) in Clinical Trials2021-05-19T19:00:10-04:00
7 02, 2018

Innovations | The time is now for eRegulatory and eSource

2021-05-19T18:40:00-04:00

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 eSource2021-05-19T18:40:00-04:00
8 01, 2018

“I have too many systems!” | The Top 4 Integrations You Need

2021-05-19T18:31:00-04:00

New technology should accelerate your studies, however, for many research sites new technologies end up adding complex and redundant processes for your team. Avoiding these additional processes requires tight integration. Moreover, many technology solutions claim to have integrations but it is important to ask exactly how they will integrate with the systems you are [...]

“I have too many systems!” | The Top 4 Integrations You Need2021-05-19T18:31:00-04:00
25 10, 2017

Your Roadmap to eRegulatory: Define Eight Critical Workflows

2021-05-19T18:25:03-04:00

Transitioning to an eRegulatory platform is full of benefits; accelerated study startup, centralized document management, the ability to review and sign documents anywhere, easy task management, remote monitoring, and more. After hundreds of successful site implementations, our team has developed a complete guide for clinical research sites and centers planning for eRegulatory, available here. [...]

Your Roadmap to eRegulatory: Define Eight Critical Workflows2021-05-19T18:25:03-04:00
25 10, 2017

Your Roadmap to eRegulatory: Establishing Goals

2021-05-19T17:57:10-04:00

Transitioning to an eRegulatory platform is full of benefits; accelerated study startup, centralized document management, the ability to review and sign documents anywhere, easy task management, remote monitoring, and more. However, nearly 80% of the sites we talk to have not yet implemented this time and cost savings workflow - why is this? The [...]

Your Roadmap to eRegulatory: Establishing Goals2021-05-19T17:57:10-04:00
24 02, 2017

What’s Your eRegulatory Strategy?

2021-05-19T17:03:28-04:00

What’s your eRegulatory Strategy? In the last year we’ve met with dozens of research teams to discuss this question. In the process, we've 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, 2) [...]

What’s Your eRegulatory Strategy?2021-05-19T17:03:28-04:00
15 12, 2016

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

2021-05-19T16:50:18-04:00

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 [...]

“My PIs are super busy and unable to try new things! How can I convince them to try eBinders?”2021-05-19T16:50:18-04:00
21 05, 2015

Paper Shadow Charts: The Hidden Barrier to eSource

2021-05-19T12:52:19-04:00

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 [...]

Paper Shadow Charts: The Hidden Barrier to eSource2021-05-19T12:52:19-04:00
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