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 [...]
Are Your Sites Aligned with ICH E6(R3) – or Are You Falling Behind? Download “How Sponsors Can Ensure Their Sites Are Aligned with ICH E6(R3)” to get a sponsor-ready checklist for compliance success. ICH E6(R3) has officially arrived — and with it, a new era of Good Clinical Practice expectations for [...]
Navigating Post-Inauguration Shifts: The Dual Impact of Policy Changes and Government Funding Cuts on Clinical Trials
Article Earth Day 2025: How Technology is Reducing Clinical Trials’ Carbon Footprint While Bringing Patients Closer to Care As we celebrate Earth Day this year, it’s the perfect time to reflect on how innovation isn’t just improving lives—it’s helping protect our planet. At Florence Healthcare, we believe in [...]
Article How Sponsors and CROs Are Transforming Clinical Trials Through Site-Facing Technology In today’s clinical research landscape, speed, efficiency, and scalability are no longer “nice-to-haves” - they’re non-negotiables. That’s why sponsors and contract research organizations (CROs) are shifting their focus to one of the most underutilized levers of [...]
Article Five Ways Site-Facing Technology Helps Sponsors and CROs Accelerate Clinical Trials In order to accelerate clinical trials, pharmaceutical sponsors and CROs are constantly striving for faster time-to-market, inspection readiness, greater team efficiency, and lower costs. But while many focus on data, timelines, and budgets, there’s a crucial [...]
Article Why Clinical Trial Sponsors are Enhancing their Site-Facing Capabilities Strategy in 2025 Clinical trials are evolving rapidly, and sponsors are recognizing the critical importance of enhancing their site-facing capabilities. In 2025, sponsors are increasingly prioritizing strategies that address operational inefficiencies, mitigate risks, and amplify research capacity. Here's [...]
Article 7 Signs Your Site-Facing Capabilities Need Attention Clinical trial sponsors face increasing pressure to optimize efficiency, maintain compliance, and accelerate research timelines. But many sponsors continue to overlook gaps in their site orchestration strategy, resulting in significant operational challenges. Here are seven signs indicating your site-facing capabilities [...]
eTMFs Uncovered: 5 Costly Misconceptions To Avoid In the realm of logistics and navigating sites’ eISF, there are few things more important than the eTMF. Organizations are inundated with technology that claims to make the building of the eISF and the integration of it into the eTMF easier, but not all eTMFs are [...]
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 [...]
How Sponsors Can Ensure Their Sites 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 [...]
How a Top 5 Global Pharma Achieved 100% Remote Site Activation with Florence During the Pandemic and Beyond See how Florence can make your trials more efficient. Request Demo
How a Global Pharma Leader Used Florence’s SiteLink to Accelerate Study Timelines and Save Over 3,000 Hours of Administrative Work See how Florence can make your trials more efficient. Request Demo
How a Top 3 Global CRO Increased Capacity and Cut Costs with Florence See how Florence can make your trials more efficient. Request Demo
How a Top 5 Pharma Scaled Remote Monitoring to Over 2,400 Sites with a 91% CRA Satisfaction Rate with Florence See how Florence can make your trials more efficient. Request Demo
How Florence Enabled a Top 5 Pharma to Keep Studies Operational in Ukraine and Build a Global Platform to Mitigate Future Risks See how Florence can make your trials more efficient. Request Demo
FREE DOWNLOAD Capability Checklist: Evaluating a SaaS-Regulated CSP for Your RFP Evaluating a SaaS-regulated CSP for clinical research can be complex. Our comprehensive checklist provides a clear, structured framework to help you confidently assess vendors and select a solution that ensures regulatory compliance, operational efficiency, and scalability. This essential resource helps [...]
Florence SiteLink® in the SaaS-Regulated CSP Category: Modernizing Document and Workflow Management for Life Sciences In an era of increasing regulatory complexity and global clinical operations, life science organizations require tools that streamline compliance, enhance collaboration, and simplify document management. Florence SiteLink exemplifies the SaaS-Regulated Content Services Platform (CSP) approach, designed specifically for [...]
Why Sponsors Pair a Site Experience Platform with a Digital Life Sciences Platform In clinical research, sponsors and CROs are increasingly adopting Digital Life Sciences Platforms (DLSPs) to manage complex trials, integrate diverse data sources, and enable decentralized or hybrid models. While DLSPs provide a solid foundation for digital transformation, they often require [...]
FREE DOWNLOAD Comprehensive RFP Checklist for a Digital Life Sciences Platform Navigating the complexities of the RFP process for a Digital Life Sciences Platform (DLSP) can be daunting. Use this detailed checklist to streamline your selection process, ensuring your organization adopts a DLSP that is scalable, efficient, and aligned with your [...]
Why Pharma Sponsors and CROs Choose Florence SiteLink® to Enhance Their RBQM Strategy Risk-Based Quality Management (RBQM) is transforming how sponsors and CROs oversee clinical trials, helping them focus on high-risk areas while improving trial quality and reducing costs. But to unlock the full potential of RBQM, you need a platform that not [...]
FREE DOWNLOAD Risk-Based Quality Management (RBQM) System Capability Checklist Navigating the RFP process for an RBQM platform can be overwhelming. This expanded checklist is designed to give you a clear, structured framework to evaluate vendors and select a solution that ensures operational efficiency, enhanced trial quality, and global compliance. You’ll gain [...]
Optimizing TMF Health: Ensuring Timeliness, Completeness, and Quality with Digital Solutions Use the checklist below to determine the current level of health of your TMF across timeliness, completeness and quality, and benchmark it against a TMF that is connected to the site’s eISF. [...]
Busting Myths About Remote Monitoring and Document Automation Remote Monitoring and Document Automation are two proven areas where Sponsors, CROs and Sites can significantly reduce costs while improving operational efficiency. However, despite the clear benefits, there are still several myths surrounding remote monitoring and document automation. Our CEO Ryan Jones addressed a few [...]
How Remote Monitoring and Document Automation Can Reduce Site Management Costs In our recent webinar on how remote monitoring can reduce costs by as much as 25%, we explored how technology can optimize clinical trials, addressing common myths and demonstrating tangible cost savings. In today’s ever-evolving clinical trial landscape, one of the most [...]
Free Download Study Planning and Start-up Checklist: Sponsor Perspective This free checklist is designed to give you the tools you need to conceptualize study objectives and develop protocols for navigating regulatory landscapes. You’ll cover the ins and outs of study planning and startup such as: Protocol Development and Feasibility Assessment Regulatory [...]
The Complete Guide to Site Enablement Platforms This free guide will provide you with valuable insights on leveraging Site Enablement Platforms to accelerate clinical trials, build trust with sites, and position your organization as a preferred sponsor or CRO. You’ll learn multiple aspects, including: The evolution, core capabilities, and benefits of Site Enablement How [...]
How Sponsors Harness Florence's Site Enablement Platform https://online.flippingbook.com/view/594313295/ Let's Cure Clinical Trials Together Request Demo
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 [...]
ATLANTA,GA - February 18, 2021 -(BUSINESS WIRE)--Florence, the largest site and sponsor connectivity platform in clinical research, announces today the launch of a new podcast series, “The Next Phase: Exploring Innovations in Clinical Trials.” Inspired by the industry’s gaps and issues exposed during the Covid-19 crisis, the podcast focuses on the need for sites, sponsors [...]
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 [...]
Watch: Florence and VirTrial Present the Future of Remote Site Access and Virtual Site Monitoring The current research landscape is transforming rapidly and evolving your operations to remote workflows is a must-do to survive and thrive. Have you seen the need to drastically change the way your organization operates over [...]
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 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 [...]
Avoid Remote Monitoring Failures with a Site-first Approach Remote monitoring is the buzz word of the hour in clinical trials. Rightfully so. As COVID-19 turns clinical operations upside down with restricted site access, the need to turn-on remote site access for start-up, monitoring, and SDV is a top priority for every Sponsor and [...]
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 [...]
On-Demand Webinar: Successful Change Management in Clinical Research Discover the secrets to building a change management plan that ensures technology adoption in clinical research and clinical trials. Watch Now Why watch? Purchasing the right software solution for your research site is only half the battle. The other half – and [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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. [...]
Recorded Webinar: Avoiding Digital Site Surprises Odds are that your CRA team is already logging into electronic investigator site files at some of your sites. Now what? View this on-demand webinar to learn how leading sponsors and CROs are taking advantage of digital platforms at trial sites. We explore the how your [...]
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. [...]
“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 [...]
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. [...]
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 [...]
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 [...]
