The Importance of Open Collaboration and Interoperability in Clinical Research Operations Andres Garcia, Chief Technology Officer at Florence Healthcare In my previous article, I emphasized the importance of technology vendors opening up their systems to enable collaboration with other vendors, sponsors, CROs, and sites in order to advance clinical research and ultimately benefit [...]

How a Clinical Trial Participant Would Use a Magic Wand to Reform Future Clinical Trials By Gunnar Esiason, Principal Key Opinion Leader of Patient Strategy at Florence Healthcare A few weeks ago, I came across an article that detailed the reforms life sciences executives would make to clinical trials if given a magic [...]

Digitising Research in the NHS Improving Research within the NHS By Simon Taylor, Head of European Solution Consulting ‘The first place it’s written down is the first place it’s documented.’ - Co-ordinators, everywhere If it's not documented, it didn’t happen. The problem is, WHERE it’s first documented matters as much as [...]

Ensuring Business Continuity in Clinical Trials: The Power of Site Enablement Platforms as an Insurance Policy Introduction Today's clinical trials are complex, often encompassing multiple countries and hundreds of research sites. In this fast-paced, interconnected world, pharmaceutical and Contract Research Organization (CRO) industries must anticipate and prepare for challenges that could threaten business [...]

A Site Point of View into Study Start-up By Kristin Surdam, Sr. Director, KOL & Strategy @ Florence Healthcare How do study start up times affect your site? Probably in far more ways than you tend to think! Elongated startup durations impede operations, negatively affect a site’s bottom line, and most importantly, delay [...]

Top 5 Takeaways from ACRP from a Site Enablement Perspective Last week, over the course of three days, hundreds of clinical research professionals gathered in Dallas, Texas, for the 2023 Association of Clinical Research Professionals (ACRP) Conference.  There were several tracks, or “journey” options, that attendees could take. One of these journeys was [...]

Revolutionizing Clinical Trials with eTMF: The Ultimate Guide to Streamlining Document Management The Electronic Trial Master File (eTMF) is rapidly transforming the landscape of clinical trials by simplifying document management, improving data accuracy, and enhancing collaboration among research teams. As the demand for efficient clinical trial management continues to grow, eTMF systems have [...]

A Comprehensive Guide to the EMA's Guidelines on Computerized Systems and Electronic Data Management in Clinical Trials Clinical trials are crucial to the development and approval of new medications. Ensuring data integrity and patient safety throughout the process is a top priority. To address this, the European Medicines Agency (EMA) has issued guidelines for [...]

Key Changes in the EMA's Updated Guidelines for Computerized Systems and Electronic Data in Clinical Trials The European Medicines Agency (EMA) periodically revises its guidelines to ensure that they remain relevant and up-to-date with the latest advancements in technology and industry best practices. In this blog post, we will discuss the key changes [...]

Breaking Down Barriers: Why Closed Technology Ecosystems are Holding Back Clinical Research This is the first in a series of posts from Florence's Chief Clinical Trial Officer Andres Garcia on building better software for clinical trial operations. The clinical research industry is complex, and as it evolves, so do the challenges we face. [...]

Six Ways Sponsors and CROs Optimize Site Performance Using Florence’s Site Activity Dashboard Clinical trial management can be a daunting task, especially when you need to ensure that all your study sites are performing as they should. With so many moving parts, it can be challenging to keep track of all the necessary [...]

Accelerating Clinical Research: 5 Ways Florence Healthcare's Mobile App Helps Sites Get Work Done Faster Saving time is crucial in clinical research. Falling behind schedule can delay regulatory approvals, miss patient recruitment opportunities, and even result in intellectual property loss. That's why it's so important to streamline workflows and eliminate unnecessary delays. Florence [...]

The Top 5 Takeaways from SCOPE Summit: Shifting Power Dynamics, Site Enablement, and More Last week, the annual SCOPE Summit brought together leaders in the clinical research industry to discuss the latest trends and challenges.  The conference highlighted the shifting power dynamic in clinical research, with sites now at the top of the [...]

Site, Sponsor, and Mobile Technologies in Clinical Trials: The Technology Landscape More than 250 companies create site, sponsor, and mobile technologies for clinical trials. Choosing between that many platforms can be overwhelming, especially when the average clinical research team already logs into six software platforms for every study.  Yet technology also has tremendous [...]

What Is Site Enablement? Site Enablement refers to any technology that prioritizes the needs of clinical research sites. Site Enablement Platforms connect sites, sponsors, and CROs to enable continuous collaboration throughout the clinical trial process.  The rise of Site Enablement marks a major shift in the clinical trial industry. In the past, sponsors [...]

Clinical Trial Technology Report Showcases 2023 Trends: Site Enablement, eISFs, and Integrations Florence Healthcare just released the 2023 State of Clinical Trial Technology Report, with dozens of insights from more than 450 clinical research sites, sponsors, and CROs.  We asked these clinical research leaders questions like: What clinical trial technology platforms they’ve already [...]

Clinical Trial Monitoring | In-Person and Remote Since 2020, clinical research teams have radically changed how they approach clinical trial monitoring–and researchers need to adapt to this change to avoid being left behind.  Before the pandemic, the most common type of monitoring was in-person monitoring, where Clinical Research Associates traveled by car or [...]

Improving Patient Retention in Clinical Trials Patient retention in clinical trials is one of the largest challenges facing sites, sponsors, and CROs. The Center for Information and Study on Clinical Research Participation found that 23% of participants who enroll in a study don’t complete it.  When a participant drops out of a study, [...]

15 Great Clinical Research Coordinator Interview Questions When deciding on Clinical Research Coordinator (CRC) interview questions, research sites need to think about how the role is changing. Gone are the days when a Clinical Research Coordinator (CRC) only needed to fill out paper forms and meet with patients.  CRCs today need to: Manage [...]

Acronyms and Abbreviations for Clinical Research You Need to Know There are dozens of abbreviations for clinical trial terms. What’s the difference between a CRA, a CRC, and a CRO? How about the difference between eISF, ePRO, and eTMF? If you’ve been in medical research for years, these clinical trial abbreviations might come [...]

Supporting Ukraine Clinical Trials During a Time of War Ukraine clinical trials continue to suffer because of Russia’s invasion. When the war began, clinical trial activity had to be frozen.  While some trials have resumed and some international trials continue to serve Ukrainian patients, the crisis raises an important question for clinical research [...]

EU Annex 11: How to Stay Compliant EU Annex 11 lays out the European Union’s regulations for using computerised systems during clinical trials. Any sponsor or site who wants their new medical treatment approved in the EU must follow Annex 11.  In this post, we’ll answer the questions:  What is Annex 11? Does [...]

How Technology Can Empower CAR T-Cell Therapy Clinical Trials CAR T-cell therapy clinical trials are among the most exciting medical advances of the past decade. Since 2017, the FDA has approved 6 CAR T-cell treatments for blood cancers, including lymphomas, some forms of leukemia, and multiple myeloma. CAR T-cell therapy offers hope for [...]

Florence Supports Diversity in Clinical Trials Through a Partnership with the Meharry-Vanderbilt Alliance Florence Healthcare is committed to supporting Diversity, Equity & Inclusion (DE&I) initiatives in clinical trials, both through the use of its software and philanthropic investment in the community. Earlier this year, Florence's executive leadership reached out to their colleagues and [...]

Medicaid coverage of clinical trials will improve inclusion: but there’s more work to do On Jan. 1, 2022, the Clinical Trial Treatment Act went into effect, requiring all U.S. states and territories to cover routine clinical trial costs for Medicaid patients. Medicaid coverage of clinical trials will bring access to the latest treatments [...]

How sites and sponsors can collaborate for a smooth site feasibility process The site feasibility process is broken. The average clinical trial coordinator spends 264 hours a year completing feasibility questionnaires for sponsors. Yet 80% of clinical trial sites still don’t complete patient enrollment on time, and 11% of sites selected for a [...]

The role of clinical trial technology in creating and managing frontier sites Historically, clinical trials have been concentrated at academic medical centers, large hospitals, and cancer centers. But under this approach, trials aren’t as inclusive or accessible as they should be. Bringing clinical trials to frontier sites–pharmacies, labs, doctors’ offices, and health clinics–can [...]

How Global Clinical Trial Regulations Impact Healthcare Technology When searching for clinical trial software, every site, sponsor and CRO has the same question: “how does this software comply with (insert clinical trial regulation here)?”  Research professionals face an overwhelming number of regulations. In addition to international guidelines like ICH Good Clinical Practice, the [...]

5 Facts You Should Know About Patient-facing Technology Patient-facing technology can make trials more accessible and help trials fit into participants’ lives. But if we’re not careful, technology built to empower patients may end up overwhelming them instead.  At the Research Revolution conference this November, we’ll be holding a panel on “Selecting Patient-facing [...]

How Community Sites Can Improve the Lack of Diversity in Clinical Trials The lack of diversity in clinical trials is one of the most pressing concerns confronting the clinical research industry. The recent FDA guidance for diversity in clinical trials calls on all clinical research sponsors and investigators to increase the racial and [...]

Why Clinical Trial Translations Matter When clinical trial sites, sponsors and tech vendors think about diversity and inclusion, we consider a variety of factors: age, race, ethnicity, gender identity, sexual orientation, ability, and more. But we often forget to think about the importance of language access and clinical trial translations, especially for trials [...]

How “frontier sites” and hybrid clinical trials can help research sites The number of clinical trials has increased rapidly since 2020. 2021 saw a 14% increase in trial starts over 2020 and a 19% increase over 2019. And while 2020 was far from a typical year, the clinical trial industry is expected to [...]

Technology Can Help Sites and Sponsors Prepare for the Rapid Growth of Clinical Trials The number of new clinical trials is expected to increase 5.8% each year from 2022 to 2030. But research sites already struggle to keep up with trial workloads. With 1,015 new trials starting in Q4 2021 alone, many major [...]

Tips for a successful clinical research software implementation It’s clear that remote work is here to stay. For industries like healthcare that have historically relied on in-person interactions and paper-based records, this means implementing new digital solutions to remain competitive.  But the clinical trial industry is highly regulated and involves managing secure patient [...]

How eConsent Can Help Legally Authorized Representatives in Clinical Trials A legally authorized representative (LAR) has a vital role to play in clinical trials, yet clinical trial software vendors too often forget to think about LARs and their needs.  Most clinical research professionals have encountered patients who are in a coma or who [...]

Battling Turnover with Clinical Trial Career Development By Andrea Bastek, PhD, Senior Director of Innovation at Florence Whether you’re a Clinical Research Associate, Research Assistant, or Clinical Research Coordinator, working in the clinical trial industry isn’t easy. Most positions require detailed regulation, protocol, and disease state knowledge, attention to detail, and the ability [...]

How to Reduce Operational Costs of Clinical Trials in Uncertain Economic Conditions Clinical trials can’t avoid fluctuating economic conditions. Changes in the market can especially impact emerging and early-stage biotech companies with limited cash reserves. A clinical trial's fate can hang in the balance when funding conditions change, especially in early phases. In [...]

Too Many Trials, Too Few CRAs: Closing the Capacity Gap in Clinical Trials The clinical trial industry has experienced 5.8% annual growth year over year–but the growth in Clinical Research Associates (CRAs) and research sites isn’t keeping up.  To accommodate the number of trials predicted in 2030, Florence estimates that Contract Research Organizations [...]

FDA Guidance for Diversity in Clinical Trials: What You Need to Know The FDA’s newest guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials,” took the clinical research world by storm.  While diversity, equity, and inclusion have been major focuses for clinical research teams for [...]

How Multinational Clinical Trials in the EU Can Benefit from Technology Multinational clinical trials play an essential role in the European Union. In 2019 alone, Europe hosted 2,900 multinational trials. This was the second-highest number of clinical trials for any region of the world, only behind the Pacific. But multinational trials come with [...]

5 Tips for Successful Decentralized Clinical Trials Decentralized clinical trials (DCTs) –trials that don’t take place exclusively at major sites–have quickly grown in popularity. 89% of sponsors use DCT methods in some of their studies, and so do 92% of hospitals and health systems.  But not everyone is excited about DCTs. Only 40% [...]

4 Ways Tech Can Help with Investigator-Initiated Trials By Taylor Davidson, Content Writer With special insights from Catherine Gregor, Chief Clinical Trials Officer, and Lauren Martin, Sr. Director of Customer Experience Investigator-initiated trials (IITs) make up nearly half of all clinical trials registered in online trial databases, and many government, industry, and nonprofit [...]

4 Trends in Clinical Research You Need to Know About from ACRP 2022 Wondering what’s next in the world of clinical research? Catherine Gregor, Florence’s Chief Clinical Trial Officer and the former Director of Clinical Research Administration at Vanderbilt, gathered this list of key trends in clinical research she noticed at ACRP 2022.  [...]

Why Sites Must Own the eISF Tell me if this sounds familiar: a sponsor needs remote access to their sites, so they buy electronic Investigator Site Files (eISFs) and distribute them to their sites. Now the sponsor has access, and the sites have new platforms to hopefully speed up their work.  However, some [...]

How Digital Connections Can Create a Positive Patient Experience in Clinical Trials Patient experience in clinical trials is a problem. On patient satisfaction surveys, clinical trials received low scores similar to the scores of Internet service providers, utility companies, and health insurers–businesses infamous for poor client experiences.  A positive clinical trial experience encourages [...]

How the New EU Clinical Trials Regulation Will Impact Sites and Sponsors The Clinical Trials Regulation (CTR) for the EU took effect on 31 January 2022. Sites and sponsors must now embrace the new regulations to successfully run clinical trials across the European Union.  To help, the European Commission (EC), Heads of Medicines [...]

Why Sponsors and CROs Are Investing in Electronic Investigator Site Files for Their Sites in 2022 The first three months of 2022 have seen a 3x uptick over the first three months of 2021 in clinical trial sponsors and CROs contacting Florence about deploying Electronic Investigator Site Files (eISFs) to their study sites. [...]

Decentralization of Clinical Trials Requires Digitization of Clinical Trials Is the Industry Wired for This Revolution? You are almost guaranteed to have heard or seen the word "decentralized" in the last year if you've been to a clinical research conference, looked at vendor emails, or glanced at any materials related to clinical research [...]

How Community-Based Clinical Trials Benefit Sponsors, Local Healthcare Systems, and Patients Clinical trials could help far more patients than they currently do. So how do we expand studies to all of the patients who need them? Community-based clinical trials might be the answer.  70% of patients live over two hours from the closest [...]

What do the proposed changes to UK clinical trial regulations mean for you? by Taylor Davidson, Content Writer With special thanks to Sara Guyler, Global Regulatory Specialist After leaving the European Union, the United Kingdom passed the Medicines and Medical Devices Act 2021. This act allowed them to update the UK clinical trial [...]

What eConsent Software Does for Clinical Trial Professionals By Andrea Bastek, PhD, Sr. Direction of Innovation at Florence and former Assoc. Director of Clinical Affairs for Abbott  82% of sponsors and 88% of research sites plan to have eConsent software by the end of 2022. That means nearly everyone who works in clinical [...]

Key Discoveries from “Innovating Inclusive Study Startup and Recruitment”: An Innovation Summit by Beau Bruneau, Innovations Business Analyst at Florence During Florence’s February 2022 Innovation Summit, over 250 clinical trial professionals met for roundtable discussions on site selection, the Site Initiation Visit (SIV), and inclusivity in recruitment. The keynote was a panel with [...]

What is eSource? By Andrea Bastek, Ph.D., Senior Director of Innovation at Florence With contributions from Beau Bruneau, Innovation Business Analyst at Florence Ask 5 clinical trial professionals what eSource is, and you’ll get 5 different answers. One person may tell you about capturing source data on a fillable PDF, while another talks [...]

Clinical Trial Diversity: Lessons Learned from a Pandemic Sites and sponsors struggled with clinical trial diversity long before the COVID-19 pandemic began. Roughly 20% of new drugs have different effects depending on a person’s race. This makes it vital for new treatments to be tested on a diverse patient population.  Yet African American, [...]

4 Key Takeaways for Sponsors and CROs from "Digitizing the Site Network"--A Fireside Chat by Blake Adams, SVP of Marketing at Florence Missed our fireside chat about how sponsors can work remotely with sites in traditional and decentralized trials? The recording with Nimita Limaye, Research VP at IDC, can be found here. And [...]

4 Key Takeaways for Research Sites from "Digitizing the Site Network"--A Fireside Chat by Blake Adams, SVP of Marketing at Florence If you missed our fireside chat about how sites can prepare for traditional and decentralized trials with Nimita Limaye, Research Vice President at IDC, you can check out the recording. Don't have [...]

Remote Trial Site Monitoring Is Permanent. Now What? If you listen, you can hear it across the industry: the job of the Clinical Research Associate (CRA) and the business of the Contract Research Organization (CRO) have permanently changed.  Crisscrossing the country from site to site is going the way of the buggy-whip, as [...]

New Year, New You? Using Change Management for Digital Clinical Trial Transformations By Rachelle Stover, MPH, CCMP With the start of a new year, both people and organizations begin thinking about change. Perhaps there’s a new technology or software your clinical trial organization would like to implement. Or maybe you want to take [...]

FAQ for the FDA’s New Guidance on Digital Health Technologies 89% of sponsors now embrace decentralized clinical trials (DCTs). With DCTs becoming commonplace, sites, sponsors and CROs have turned to the FDA for guidance on how to use clinical trial technology compliantly.  In December 2021, the FDA responded to this need with the [...]

7 Key Findings from the 2022 Clinical Trial Operations Technology Survey 2021 brought massive changes to the clinical trial industry. With the advent of the COVID-19 vaccine, many clinical trials delayed by the pandemic sprang into motion again.  44% more clinical trials began in Q1 2021 than Q1 2020. And although in-person clinical [...]

Patient Engagement: The True Benchmark in Clinical Trials By Catherine Gregor, MBA, CCRC, CCRP This article originally appeared in STAT+. You can find it here.  Patient engagement and community outreach may be hot topics in today's clinical trial landscape, but they aren't new ideas. Researchers and patient advocacy groups have focused on including [...]

Are Clinical Trial Teams Prepared for ICH E6(R3)? ICH E6(R2), the current global standard for good clinical practice (GCP), went through an update in 2016–and it’s already undergoing another major revision. With how quickly changes are happening, even seasoned clinical trial professionals could find it hard to keep up with all the changes to [...]

3 Ways eConsent Can Help You Earn IRB Approval by Crystal Stargell, Associate Product Manager for Florence and former Clinical Regulatory Coordinator Informed consent is arguably the most important element of clinical research. It’s during the informed consent process that participants learn about their rights, what they’ll be asked to do during the [...]

What do patients think about decentralized clinical trials? Research sites and sponsors can’t stop talking about decentralized clinical trials (DCTs). But we often forget to ask a vital question: how do patients feel about them?   As of 2021, 95% of research sites use at least one form of decentralized technology, and almost every [...]

Vaccine Race: How to Start Up Study Sites Quickly and Remotely COVID-19 caused clinical trials to go digital at an incredible rate, with 97% of sponsors embracing remote monitoring.  Research sites and sponsors needed virtual environments for their ongoing trials. But more urgently, they needed a global digital infrastructure so they could test [...]

Helping Your Research Site Go Paperless In November 2021, Florence hosted over 200 clinical research professionals at the first-ever Innovation Summit to discuss the latest trends in clinical trials.  Going paperless was the most popular topic, with dozens of clinical research experts sharing how they use technology to run their trials.  From these [...]

How Tech is Changing the Role of a Clinical Research Associate The role of a Clinical Research Associate (CRA) changed dramatically during the pandemic. 76% of CRAs did most of their monitoring visits remotely in 2020, up from just 18% in 2019. And technology advances haven’t slowed down since. In 2021, 97% of [...]

What does a modern Clinical Research Coordinator do, and how can technology help? Clinical Research Coordinators (CRCs) play a crucial role in the success of research sites. With a wide range of responsibilities, the CRC is the “heart” of a clinical trial—the champion of the protocol, the guardian of the patients, and the [...]

Becoming a Digital Contract Research Organization The New Standard for CROs 80% of sponsors and Contract Research Organizations (CROs) expect study start-up, recruitment, consenting, source data collection, and monitoring to be mostly digital by 2023.  Many CROs have kept up with this trend by embracing decentralized trials that combine digital technology with in-person [...]

9 Facts to Know About ICH E8(R1) If You Run Multicenter Trials In October 2021, an event took place that the world had waited 25 years for: ICH E8 released its first revision. (Okay, maybe the world hadn’t been waiting—but the clinical research world had been!)  ICH E8(R1), the first major revision to [...]

How Remote Site Access Is Changing Clinical Operations By Blake Adams, VP of Marketing and Growth for Florence 90% of clinical trial sponsors rely on some form of remote monitoring. This statistic makes reliable, efficient remote site access more important than ever. Through our network of 10,000 study sites in 44 countries, the [...]

Top Considerations When Choosing eConsent Software 75% of research sites either already use eConsent or plan to use it in the near future. That means the question is no longer “does my site need eConsent?” but “which eConsent platform do I need?”  If your site improvised a way to do electronic informed consent [...]

Six Ways to De-risk eConsent for Sites By Blake Adams, VP of Marketing at Florence 75% of research sites either already use electronic informed consent or plan to use it in the future. Sites without this technology will quickly fall behind when competing for sponsors and patients.  But as efficient and popular as [...]

Advance Your Career with Florence’s New Digital Research Certification By Charlotte Boyd, Sr. Manager, Community and Customer Marketing, Florence The explosion in remote clinical trial technology over the past two years has changed how clinical research teams work together. Florence wants to help you manage these changes with our new certification course in [...]

How Cybersecurity Protects Participants in Clinical Trials Special thanks to Zack Wilkinson, Information Security Manager at Florence, for his contributions to this article.  Cybersecurity in clinical trials matters. We’re all afraid of having our data stolen, and data breaches of companies like Facebook, Instagram, and TMobile have made people hyper-aware of where their [...]

How Clinical Trial Technology Can Help Contract Research Organizations Contract research organizations (CROs) play a vital role in clinical trials. The CRO market was worth $61 billion in 2020 and is expected to reach $99 billion in 2026. In the midst of the pandemic, CROs helped sponsors test COVID vaccines and also kept [...]

The Life Cycle of Informed Consent in Clinical Trials by Kathryn Meagley, Senior Product Manager at Florence and former Clinical Research Manager at the Atlanta Veterans Affairs Medical Center Historically, informed consent in clinical trials has consisted of excessive, time-consuming paperwork. I became a clinical research coordinator and manager because I wanted to [...]

The Challenges of Oncology Clinical Trials (and How Tech Can Help) Over the past 10 years, the number of oncology clinical trials has grown almost twice as fast as the number of trials for any other disease. Oncology trials are a vital source of income for research sites and sponsors and a vital [...]

The Benefits of eConsent Forms for Clinical Trials by Andrea Bastek, PhD, Director of Innovation at Florence and Former Senior Field Clinical Engineer at Abbott 75% of research sites either have some form of eConsent or want to adopt an eConsent platform in the future. But as sites learn about electronic consent and [...]

5 Strategies for Effective Clinical Trial Site Management Clinical trial site management costs sponsors and CROs millions of dollars each year. One report estimated that completed clinical trials cost between $44 million and $115 million each.  Of those costs, 11-29% comes from paying administrative staff, while 9-14% comes from site monitoring and 9-16% [...]

What is eConsent eConsent, software that lets trial participants read and sign informed consent documents online, has exploded in popularity. As of July 2021, 57% of research sites use eConsent applications, and 18% of sites plan to use them in the future.  If you choose the right eConsent software, you can improve patient [...]

How to Use Patient Engagement Technology in Your Clinical Trials Clinical trial sites embraced remote patient engagement technology in 2020 and 2021. 95% of research sites now offer telemedicine visits, while 94% use electronic patient diaries and 91% use electronic informed consent documents. All of these forms of tech keep patients involved in [...]

Combating Burnout in Clinical Research This is a modified version of an article that first appeared in STAT. Check out the original here.  In the midst of battling a pandemic, healthcare professionals are also battling burnout and mental illness. Though people recognize the struggles of physicians and nurses, clinical research professionals often get left [...]

Florence Receives Awards for Company Culture and Innovation Successful, sustainable companies must balance growing quickly with supporting and valuing their employees. That’s why Florence was thrilled to receive several awards for building a great place to work and for our technical innovation in 2021.  Like almost every company, we had to make sure [...]

How to Improve Patient Diversity in Clinical Trials Research sites struggle with patient diversity in their clinical trials, and this can have a negative impact on treatment outcomes. In 2018, African American people made up 13.4% of the U.S. population but just 5% of clinical trial participants. Hispanic people made up 18.5% of [...]

FDA 21 CFR Part 11 Compliance: Frequently Asked Questions Many clinical trial sites want to use technology but worry about compliance, especially 21 CFR Part 11 compliance. Using technology that isn’t compliant can lead to audits and stressful communications with the FDA. You have to choose compliant technology to use technology in clinical [...]

The study start-up process overflows with important but stressful tasks. Research sites need to determine whether a study is feasible and convince a sponsor to select them for the study. Then sites need to recruit eligible patients, create and complete all of their regulatory documents, and assemble their Investigator Site Files before the sponsor’s [...]

Mastering the Clinical Trial Feasibility Process Clinical trial feasibility comes down to a simple question: if a sponsor runs a clinical trial at a research site, will that trial succeed?  However, answering that simple question is a complicated process. Sponsors have to determine which research sites have the participants, staff, expertise, and technology [...]

What Is a Patient-Centric Approach in Clinical Trials In 2020, accommodating patients with telehealth calls, at home-visits, or wearable devices became commonplace. But once COVID-19 vaccines arrived, research sites and sponsors were confronted with a question: should they continue running patient-centric hybrid or virtual trials, or switch back to traditional site-based trials? Many [...]

Remote Connectivity is Now a Requirement in the Site, Sponsor, and CRO Relationship Author: Blake Adams, VP of Marketing for Florence Healthcare “Within hours, our clinical operations had to be fully remote. Patients couldn’t come on-site. Our team couldn’t get into the clinic. But we had to keep our studies on track and [...]

How the Right Software Can Help Sites and Sponsors Navigate the FDA Approval Process Sponsors, CROs, and research sites in the U.S. have always understood the importance of the FDA approval process. But with the arrival of COVID-19 vaccines, the general public has started paying closer attention to the FDA’s actions.  All of [...]

5 RFI Questions for Vendors Specializing in Remote Site Access Solutions Many sites in the current pandemic landscape have limited or restricted on-site monitoring visits, increasing the demand for remote site access solutions across the industry. This shift is causing the clinical research industry to evolve and embrace technology solutions at a never-before-seen [...]

Key Trends in Oncology Clinical Trials: The 2021 AACI CRI Meeting The AACI Clinical Research Innovation Meeting always provides exciting insights for teams who run oncology clinical trials. Whether you’re thinking about how to use remote monitoring, how to recruit diverse participants, or how to accelerate your study start-up time, the Association of [...]

Diversity in Decentralized Clinical Trials | Why it’s Important and How to Improve Many medical professionals worry about a lack of diversity in clinical trials, and this lack can have medical consequences. A 2014 study showed that around 20% of new drugs approved between 2008 and 2013 had different effects depending on a [...]

9 Challenges and Risks for Launching Decentralized Trials Decentralized clinical trials have exploded in popularity. A WCG survey showed that 94% of research sites have adopted at least one decentralized method, and 88% of sites have already hosted hybrid trials that combine remote technology and in-person site visits.  But decentralized clinical trials also [...]

Clinical Trial Technology Transformation: Creating an Effective Environment The clinical research industry has historically been a laggard in technology adoption compared to other industries in healthcare. However, the COVID-19 pandemic lit the match, pressuring the industry to move out of the dark ages and change the technology status quo – accelerating the technology [...]

Building Clinical Trial Software Integrations Between Sites and Sponsors As decentralized clinical trials become more popular, many sites and sponsors have begun to wonder how they can adopt decentralized methods without sacrificing compliance or efficiency.  The COVID-19 pandemic proved that patients can participate in clinical trials using video calls, apps, wearable devices, and [...]

Understanding Data Privacy: Three Key Concepts for Your Clinical Trials Personal data privacy is not a new concept when it comes to healthcare. In fact, the right to privacy hasn’t changed in over 130 years. In the mid-1990s, when the utility of the Internet was in question, the future-focused US Congress was determined [...]

Top Healthcare Software to Power Decentralized Trials Because decentralized clinical trials use healthcare software to share data remotely, decentralized trials can’t succeed without the right technology. But with dozens of clinical research platforms flooding the market, it keeps getting harder to figure out what they all do and which ones you need.  Although [...]

Decentralized Clinical Trials in a Post-Pandemic World: Interview with Amir Lahav Now that COVID-19 vaccines are available, many sponsors and research sites have started to wonder which elements of remote clinical trials should stay and which ones need to be left behind. Blake Adams, VP of Marketing at Florence, sat down with Amir [...]

Clinical Research Sites Discuss Moving Beyond COVID After the chaos of the past year, many of us wonder which of the changes we’ve made to allow for remote work will continue and which will get tossed aside as the clinical research industry evolves.  If you work at a study site, figuring out what [...]

Five Ways Decentralized Trials Will Impact the Study Site Decentralized trials will have a major impact on study sites and the clinical trial process. Some organizations refer to decentralized trials as “site-less” trials, but we disagree. As a clinical trial technology vendor we think that, rather than taking power away from sites, trials [...]

Clinical Trial Sponsors and CROs Discuss Moving Beyond COVID The COVID-19 pandemic created an unprecedented challenge across the clinical research industry. For sponsors and CROs, it meant developing a lifesaving vaccine and continuing ongoing clinical trials while navigating strict, yet necessary, regulations limiting on-site access at research sites. In this excerpt from our [...]

5 Benefits of Cognizant® SIP and Florence eBinders Integration Although technology can simplify and automate many of the tasks associated with clinical operations, individuals are frequently forced to perform repetitive work across various platforms. For sites using the Florence eBinders platform conducting studies with sponsors using the Cognizant Shared Investigator Platform, this repetitive [...]

7 Steps to Seamlessly Implement Clinical Trial Technology This post is written by Amanda Korey and was originally published on pharmalive.com here. In the past year, the clinical research field has been challenged to consider remote clinical trial technology solutions. Without these solutions, research efforts that rely on paper documents, on-site visits from [...]

How Technology is Impacting Clinical Research Careers As COVID reshapes the national work landscape, there are massive shifts in clinical research. Many technology advancements focus on enabling remote processes and refining workflows that will transform job roles for clinical research professionals. In the third episode of The Next Phase: Exploring Innovation in Clinical [...]

Why COVID-19 is Accelerating Technology Transformation in Clinical Research This article was originally published on STAT News by Andrea Bastek, Director of Innovation at Florence. Before the onset of the coronavirus pandemic, leading organizations in clinical research had been gradually discovering, experimenting with, and implementing remote technology. The pandemic has catapulted their [...]

Why Accessible Technology Matters in Clinical Research Most of us whiz around the internet and various online applications every day to get work done and progress in our careers. But this is a very different experience for someone with a disability. How difficult would it be to get simple tasks done if you [...]

Overcoming 4 Challenges in Multicenter Clinical Trials Efficiently managing multicenter clinical trials is an essential capability of the modern research center. Complex protocols often require diverse subjects spread across a vast network of research sites - increasing pressure on the coordinating center to streamline operations, maintain oversight, and avoid compliance risks. While the [...]

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 are conducted. Over the last five years, the [...]

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 timeline and reduce development costs. This growth is 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 drives good clinical research. As the industry saying goes, “If it isn’t documented, it doesn’t exist." But monitors often discover a lack of adequate source documentation during inspections. 6 out of 10 warning letters issued to clinical investigators by the FDA cited: Failure to maintain adequate and accurate case histories that record [...]

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 [...]

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 [...]

Atlanta, GA, September 10, 2018 (Newswire) - Florence, a fast-growing Atlanta based company building software that advances clinical research, has been named one of the top 100 Best Places to Work in 2018 by the Atlanta Business Chronicle. Florence was named the #11 best place to work in the small business category. “This honor is a testament to our team,” [...]

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 2,000 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" and [...]

“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 [...]

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 [...]

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 [...]

ATLANTA, GA – February 21, 2018 – Florence was named one of the Top 40 Innovative Technology Companies in Georgia by the Technology Association of Georgia (TAG). TAG’S Top 40 Awards recognize Georgia-based technology companies for their innovation, financial impact, and their efforts at spreading awareness of the state’s technology initiatives throughout the U.S. [...]

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 [...]

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 [...]

Today electronic health records are now entrenched in the care experience after a painful adoption cycle. In fact, the last ten years were the decade of EHR adoption, with penetration growing from 17% to nearly 80% over the period, according to the CDC. EHR Adoption Affordable Care Act mandates drove this growth more recently [...]