Article What Researchers Need to Know About Executive Order 14117 and 28 CFR Part 202 The Basics In early 2024, Executive Order 14117 was signed to protect Americans’ bulk sensitive personal data and government-related data from access by countries of concern. The Department of Justice implemented [...]
Article Aligning with ICH E6(R3): A Sponsor’s Roadmap to Modern GCP Compliance The long-anticipated finalization of the ICH Good Clinical Practice (GCP) E6 R3 was achieved on January 6, 2025, marking a milestone in global clinical research. The principles and Annex 1 of ICH [...]
Article How AI-Powered Contracting Is Accelerating Clinical Trials - and Saving Lives In clinical research, time isn’t just money - it’s hope. And in many cases, it’s survival. Every delay in getting a clinical trial off the ground means patients wait longer for potentially life-saving treatments. One of [...]
Opinion Reform, Not Ruin: A Careful Look at HHS’s Deregulatory Push On May 14, 2025, the U.S. Department of Health and Human Services (HHS) kicked off what it calls the largest deregulatory effort in its history. It’s asking stakeholders across all sectors to weigh [...]
Opinion We Need Regulatory Clarity—Not Complexity in Clinical Trial Technology As a software vendor supporting Sponsors and Sites across the clinical research ecosystem, Florence builds workflows to enable compliant, remote-first trials. Every product decision we make is shaped by regulatory expectations. The current U.S. [...]
Article UK Clinical Trials Reform: What You Need to Know The UK has initiated its most significant update to clinical trials regulation in over two decades. These reforms aim to streamline approvals, reduce administrative burdens, and foster innovation, positioning the UK as a leading destination for clinical research. [...]
Article Clinical Trials in Canada: 2025 Regulatory Insights and Privacy Watchouts Canada plays an important role in the global clinical research landscape. With over 3,500 ongoing and planned studies and approximately 900 new trials authorized each year by Health Canada, the country maintains a steady level of research [...]
Article HHS Budget Cuts Threaten the Future of Clinical Trial Innovation As Chief Clinical Trial Officer at Florence Healthcare, I have the privilege of collaborating with research sites, sponsors, and CROs on the frontlines of clinical trial operations. Every day, I witness the dedication [...]
Article Navigating Regulatory and Privacy Updates in Clinical Trials Staying compliant and efficient in the ever-evolving landscape of clinical trials is crucial, especially for Canadian sites and sponsors. In a recent Florence Healthcare webinar, we addressed important regulatory updates, privacy considerations, and strategies to streamline research efforts, particularly [...]
How Sites can ensure they are aligned with ICH E6 R3 The long-anticipated finalization of the ICH Good Clinical Practice (GCP) E6 R3 was achieved on January 6, 2025, marking a milestone in global clinical research. The principles and Annex 1 of ICH E6(R3) have reached Step 4 and are transitioning into Step [...]
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Interpreting the FDA’s 2023 Guidance Impact on Site Enablement Platforms: Considerations for the Conduct of Clinical Trials of Medical Product During Major Disruptions (d/t Disasters and PHEs) Introduction In September 2023, the FDA released new guidance that supersedes the COVID-19 pandemic guidance issued in March 2020 along with the updates made to [...]
FDORA-Omnibus Act 2022: Implications for Clinical Trials and Healthcare By Catherine Gregor, Chief Clinical Trial Officer, Florence Healthcare As a dedicated clinical trial nerd, I have been closely following discussions around the FDA Omnibus Reform Act (FDORA) passed at the end of last year. What does an omnibus act have to do with [...]
Watch: Moving Beyond COVID - The Sponsor and CRO Perspective on Lessons Learned Hear from a panel of top clinical operations leaders from the world's largest pharma companies, like Pfizer, to a company transforming how CROs operate to learn how they adjusted their people, processes, and technology; and what lessons [...]
Watch: Avoiding Failure When Migrating to a New eTMF In theory, the Trial Master File (TMF) is a collection of documentation that tells a cohesive story. But all too often sponsors are left piecing this story together retroactively due to disjointed site and sponsor systems, outsourced TMF management, and traditional [...]
Tips for Managing Data Protection and Data Privacy in Clinical Trials Technology continues to play a larger role in clinical trials, and subsequently, regulatory bodies are placing intense scrutiny on data protection and data privacy in clinical trial procedures and policies. Learning all of the new jargon and terminology related to electronic data protection [...]
Beginners Guide to Global Data Protection Regulation (GDPR) for Clinical Trials To remain compliant, you need to understand how GDPR affects your clinical trial operations. This guide offers insight the main terms that can be used to help you better understand the language utilized throughout the GDPR documentation and understand your organization’s [...]
Four Tips to Get Your CRAs and Sites to Adopt Remote Clinical Monitoring As a sponsor interested in investing in a remote clinical monitoring platform in clinical trials, it is important to determine how you will support your Clinical Research Associates (CRAs) during and after the transition. CRAs are the main personnel who [...]
Top Five Ways Study Sites Benefit from Remote Monitoring Failed remote site access and clinical trial monitoring attempts have left sites with a computer full of site portals, FTP logins, document vaults, and emails. Why do sponsor remote site access and monitoring rollouts fail? Because the sponsor focuses on solving their site access [...]
Selecting an eTMF Vendor that Empowers Site Collaboration Not all sponsors and CROs that select and implement an Electronic Trial Master File (eTMF) solve the bottlenecks and inefficiencies that the system was selected to target. Why? Often, during the vendor selection process, organizations undervalue the impact of vendor support teams, overlook critical implementation processes, [...]
The Overall Organizational Impact of a Modern eTMF Implementing an eTMF is critical for Sponsors and CROs that want to reduce burden, increase study capacity, and enable more trials. However, many organizations are not equipped with a modern solution to realize the full benefit and future proof operations. With over 10,000 research sites connected to [...]
Regulatory Compliance in the Global Clinical Research Evolution The wheels of globalization have been turning at Florence for more than five years. As a purpose-built clinical trial document, data, and workflow management solution, Florence has its roots at the heart of research - the clinical trial site. Since Florence's inception in 2014, [...]
Free Download Complete Guide to the Modern Electronic Trial Master File (eTMF) Best practices from hundreds of successful eTMF deployments. This guide covers: The impact of a modern, active eTMF Return on investment & quality control Compliance with FDA regulations Vendor selection and more! Make sure your eTMF solution satisfies the [...]
Florence Healthcare Launches The Florence Effect: A Global Awareness Initiative Honoring Clinical Research Professionals ATLANTA, May 20, 2020 – Florence Healthcare, the leading platform for electronic document workflow management in clinical trials, has launched a global initiative during May to celebrate and bring together those who are accelerating medical cures through Clinical Research. [...]
Florence Clinical Trial Research Network Hits Milestone in Remote Site and Sponsor Connectivity ATLANTA, GA - May 19th, 2020 - Today, Florence announces its rapidly expanding clinical research sponsor and site connectivity platform is now in use at more than 7,200 research sites and by 18,000 research professionals across 27 countries – making it [...]
How to Prepare Research Sites for Rapid Technology Evolution Before a research site can take advantage of new technology platforms, it must first ensure it has a solid foundation from which to build. Research sites that have not prepared for the coming wave of technology advancements will find themselves lagging behind their peers [...]
Gathering and securing data throughout the lifecycle of a clinical trial is of utmost importance in order to preserve study integrity. To facilitate this collection of critical data, researchers need access to various case report forms. Luckily, many reputable institutions have created databases to address this specific need. We’ve compiled a comprehensive list of [...]
The COVID-19 pandemic has touched nearly every part of our lives, and the universal impact has been astounding. The result has undoubtedly created a shock across Clinical Trials teams around the globe. Research teams are now facing new, often difficult decisions regarding the progress of their studies and the safety of their team members. [...]
Busting 8 Common eRegulatory Myths If you have not invested in an eRegulatory solution, you most likely have a mental list of reasons why. You’re not alone. While a majority of clinical research sites now use a purpose-built platform (61% surveyed in 2020), those who do not often list reasonable barriers to [...]
7 Misconceptions About Managing Clinical Research in the Cloud In a world with more data and less time, the advantages of cloud-based technologies are hard to ignore. Conveniences like real-time collaboration and increased efficiency are influencing how we live and work more now than ever before. Clinical research is no exception. Researchers are [...]
Announcing Florence Collaboration with Shared Investigator Platform (SIP) Orlando, FL, February 24, 2020 (Newswire.com) - Last week at SCOPE Summit Florence announced a strategic collaboration with Cognizant. The collaboration aims to accelerate clinical research by integrating its industry-leading Florence eBinders Electronic Investigator Site File (eISF) platform with the Cognizant Shared Investigator Platform (SIP). The two companies announced [...]
eISF Reference Model Overview You’ve likely heard that the MAGI Global eISF / eReg Binder Reference Model Version 0.9 is open and available for review. By now, you may be wondering what’s next for me and my organization? Our representative on the MAGI eISF Reference Model Steering Committee, Jordan Tapley, walks us through [...]
ATLANTA, February 10, 2020 (Newswire.com) -Florence, an Atlanta-based clinical trial software company, today announces the introduction of v0.9 of the Global Electronic Investigator Site File (eISF)/eRegulatory Binder Reference Model. This reference model was developed in collaboration with WCG MAGI and numerous clinical research technology experts to ensure interoperability between eISF platforms, eTMFs, and other systems. [...]
Selecting the right eRegulatory platform with the features you need is only half the equation; the other half is successfully implementing the platform at your research organization. In this guest article, Yvonne Gorham shares her tips for successful eRegulatory implementations. Yvonne has over 20 years of clinical research operations experience and helped navigate the [...]
Download: Guide to Successful Change Management in Clinical Trials Your guide to building a successful organizational change management plan that maximizes return on investment of new clinical trial technology. Purchasing the right software solution for your research site is only half the battle. The other half – and arguably the more important [...]
Download: Electronic Investigator Site File (eISF) Reference Model The Electronic Investigator Site File (eISF) Reference Model, developed in collaboration with WCG MAGI and all leading Electronic Investigator Site File (eISF) vendors, is the standard template for setting up the eISF at the research site and maps directly to the TMF Reference Model. [...]
Building an eISF Reference Model: Six Reasons Sites Benefit The eISF Reference Model is the industry standard for setting up and managing an Electronic Investigator Site File designed by all of the major eISF vendors, along with research sites and sponsors. The Electronic Investigator Site File (eISF) is projected to be in use at over [...]
Atlanta, GA, January 16, 2020 (Originally Published at Newswire.com) - Florence, an Atlanta-based clinical trial software company, today announces that it doubled the number of Research Teams using Florence eBinders to accelerate clinical trial workflows in 2019. “Our mission is to accelerate cures with technology, and we believe the best way to do that is [...]
Watch: eRegulatory: One Year Later Listen to this recording of our guest panel of clinical trial site representatives discussing the realities of implementing an eRegulatory solution. During this webinar research organizations like Moffitt Cancer Center and the University of Arizona Cancer Center shared first-hand stories of implementing eRegulatory including: What benefits [...]
Atlanta, GA, September 12, 2019 (Newswire.com) - Today, Florence announced over 7,300 clinical researchers now conduct clinical trials through its innovative Electronic Investigator Site File (eISF), Florence eBinders - a growth of more than 200% this year. “The number of teams worldwide now managing their eISF with Florence is representative of our focus on making the best possible [...]
Why Remote Clinical Trial Monitoring is the New Standard The COVID-19 pandemic has accelerated the ongoing shift to remote clinical trial monitoring. Remote site access and monitoring platforms are now an essential element of the clinical trial process and a vital connection between the sponsor, clinical research organization (CRO), and the research site. [...]
Watch: eTMF + eISF Integration - Why and Why Now? Discover how it is now possible to directly integrate the eTMF and the Research Site eISF to accelerate research by connecting in a unified digital ecosystem. The use of electronic documentation in clinical trials, both at the site (eISF) and the [...]
Webinar Recording: Best Practices for Managing Multicenter Research As the number of multicenter trials continues to grow, it is essential that coordinating centers begin thinking about their technology like a sponsor. This is especially important when it comes to the management of your data and documents. Leading coordinating centers are now [...]
Best Practices for eISF and eTMF Integration Electronic Investigator Site Files (eISF) are now attracting the attention of progressive sponsors and CROs. Here, we’ll explore the different approaches and stages for connecting the site eISF directly to the sponsor Electronic Trial Master File (eTMF) and how this adjustment impacts the way clinical trials [...]
Managing and Organizing Multicenter Clinical Trials with Technology Are you part of a multicenter clinical trial? If not, you may be soon. Multicenter clinical trials, where a sponsor or CRO relies on a highly developed coordinating center to manage a network of sites, continue to gain popularity among sponsors looking to accelerate study [...]
Learn what Capabilities an eTMF Needs to Power Your Clinical Operations Effectively. In this free eTMF capabilities and evaluation checklist, you'll get insights into what features and functionality you should look for in an eTMF for your clinical trial operations. Compiled from working with hundreds of sponsors, CROs, and research sites. In [...]
Over the course of the past 10 years, significant advancements have been made in clinical research. Personalized medicine, immunotherapies and genomic testing have equipped researchers with the tools necessary to identify the biological causation of diseases and to target treatments accordingly. Yet in the face of therapeutic innovation, clinical trial operations have remained old [...]
Good documentation is vital to good clinical research. As the saying goes, “If it isn’t documented, it doesn’t exist”. In fact, one of the most common inspection findings in investigator site inspections is the lack of reliable, accurate, and adequate source documentation. Failure to maintain adequate and accurate case histories that record all observations [...]
The Florence team just returned from the 2019 TMF Summit in Orlando, and interestingly, the core conversations throughout the conference were not really about TMFs. The innovation frontier in our industry has moved beyond core eTMF features and is now focused on the ring of activities surrounding them. What does a “Post eTMF” (or [...]
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 [...]
Today’s clinical trial operations leaders are in a challenging and expanding role. You are expected to increase study capacity, manage more complex trial protocols, accelerate study startup, and ensure timely sponsor collaboration - all while remaining hamstrung by limited resources, siloed data, stronger regulations, changing sponsor demands, and a growing site footprint. Clinical [...]
Download: Four Strategies Clinical Trial Operations Leaders can use to Advance Research in 2019. Strategies for improving operations through technology. Clinical trial leaders, now more than ever, are expected to effectively increase capacity and accelerate operations without expanding budgets or their workforce. This new demand is in response to rising trial [...]
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 [...]
Moving to an eRegulatory/eSource solution generates measurable impact on clinical trial study startup timelines. Research teams reduce startup time by as much as 40% through harnessing the built-in features of eBinders combined with excellent standard operating procedures. Below are the top ten features more than 3,000 research teams are using to accelerate their study [...]
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 [...]
Part 1: Lack of Oversight Discussion of FDA inspections, whether for cause or part of a routine GCP inspection, usually centers on the inspection of trial sites and the CROs who are tasked with managing them. The reason for the disproportionate focus on the inspection of trial sites and CROs stems from two material [...]
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. [...]
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. [...]
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" [...]
“Blockchain will change the world!” This is the common message found in search engines and blog posts across the internet. But really, how many times have you heard this message before? It seems that a new, life-changing technology launches daily, so when should you actually pay attention to one of these “breakthroughs”? The answer [...]
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 [...]
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 [...]
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. [...]
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 [...]
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 [...]
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 [...]
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 [...]
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) [...]
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 [...]
