10 Game-Changing Features You May Have Missed in Florence eBinders Florence eBinders is constantly pushing the boundaries to help research sites accelerate studies, mitigate risks, and maximize capacity. Over the past year, we’ve launched powerful features designed to supercharge your workflows, ensure rock-solid compliance, and unleash your team’s full potential. Here’s a rundown [...]
Florence @ SCOPE Looking to boost site adoption of your clinical innovations? Insights await at the Florence booth. Our experience with 18k sites across 50+ countries and partnerships with over 3,200 sponsors has taught us a thing or two on how to make disruptive innovations site-friendly. Come chat with us to learn how [...]
4 Ways Site Enablement Platforms Support The White House’s Call for a Stronger Clinical Trial Infrastructure The White House Office of Science and Technology Policy (OSTP) recently announced the launch of The Clinical Trials Readiness initiative on October 26th. This announcement highlights the need for a stronger clinical trial infrastructure to support better [...]
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. [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
In this interview, we talked with Lauren Begnaud, Manager of Regulatory Affairs at the US Oncology Network, to discover how she successfully migrated 65 trial sites, 400 studies, and 2,000 Investigators and Support Staff to Florence eBinders for eRegulatory. Lauren has over 10 years of experience in the clinical research field and has successfully [...]
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 [...]
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. [...]
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. [...]
On-Demand Webinar: Surviving an FDA Inspection with eRegulatory In this recorded webinar our panel of experts from Florence and LMK Clinical Research discuss how an FDA inspection works with eRegulatory, what the FDA is looking for, and how to prepare your site for a successful inspection. This recording is no longer available. [...]
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" [...]
Webinar: Blockchain and Clinical Trials Watch this on-demand webinar as our Chief Technology Officer explores the impact of Blockchain on Clinical Trials, and if you should be planning for it at your organization. Blockchain’s potential impact on the healthcare space is immense. The buzz surrounding blockchain technology is warranted and should [...]
Webinar: Solving Clinical Trial Inefficiencies with eRegulatory In this on-demand webinar our team examines how leading clinical trial sites are solving clinical trial operation inefficiencies with eRegulatory. Introducing eRegulatory into clinical trial trials is proving to deliver real operational improvements with a measurable impact on efficiency for thousands of trial sites. [...]
“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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
The 4th Annual Embracing Change Conference for Clinical Research was a well-produced event from Arizona State University’s Clinical Research Management program. If you did not make it and would like a copy of the Status of Paperless Trials Presentation, send Florence a short email by clicking here. A substantial portion of the conference revolved [...]
What does a modern Clinical Research Coordinator do? Clinical research coordinators (CRCs) play a crucial role in ensuring the success of research sites. Managing a myriad of responsibilities throughout the day, the Clinical Research Coordinator is the “heart” of a clinical trial – the champion of the protocol, the guardian of the patients, [...]
PCCTC Collaborates with Florence Healthcare to Enhance Regulatory Document Management Capabilities ATLANTA, GA and NEW YORK, June 10, 2016 – Florence Healthcare, developer of the innovative trial site-focused electronic trial site and master file (eTMF) platform, eBinder Suite™, and the Prostate Cancer Clinical Trials Consortium (PCCTC), the nation’s leading multicenter clinical research organization specializing [...]
Shadow charts develop for various reasons in clinical research as discussed in a prior post on shadow charts. They emerge at trial sites because of disparate IT systems: for example an EHR record may be printed onto paper for editing, redacting and signing before being rescanned into a study portal. The remaining stub is [...]
The views expressed in the interview are solely of the individuals involved and do not represent the views of the associated organization. Interviewer: Mike Kassin, MD, Florence Healthcare Learn more about paperless trials today. Speaker: John McAdams, Manager, Data and Safety Monitoring, UCSF Helen Diller Family Comprehensive Cancer Center ___________ With increasing site workload and protocol [...]
The phrase “Audit Ready” is casually tossed around as a standard practice for both sites and sponsors. When I worked as a research coordinator I went to great lengths to make sure my binders were audit ready, particularly for one study that was deemed a high risk for inspection due to the novel nature of the [...]
With banking, stock trading, and now health records becoming electronic, what’s stopping someone from obtaining every detail about our lives? In clinical research, keeping Protected Health Information (PHI) – patients’ personal and identifiable information — secure is the key concern. Losing this means potentially harming the patient, running afoul of laws like HIPAA, and [...]
On June 11, 2015, the International Conference on Harmonization released the draft update of Good Clinical Practice guidelines. The addenda feature important changes affecting investigator oversight, document processes, monitoring plans, and validation (the changes will not be final until November of 2016). Each of these pulls the tide towards further electronic management of clinical trials. With [...]
Recently, the British Medical Journal published an analysis on how pharmaceutical companies publicly address Complete Response Letters (CRL) from the FDA, more specifically from the Center for Drug Evaluation and Research (CDER). While the EMA publishes data from refusal assessment reports, the FDA does not fully disclose information with CRLs because of privacy rules around unapproved [...]
Ask any pharmacist about the quality of a doctor’s signature and you will hear horror stories about the scribble that is every doctor’s signature. Doctors' signatures are always so hard to read. The signature represents the doctor giving their approval to a plan of care. This signature of approval represents the years of studying [...]
According to Florence Healthcare’s wearablesandapps.com, a database surveying 85 connected devices, the majority of wearable health devices are focused on activity tracking. But with wearables now supporting almost 31 different measurements, companies making heart rate, blood pressure, glucose, and temperature devices are pushing vital metrics into the sphere of diagnostic care. According to the [...]
