3 of the Biggest eConsent Myths – Busted! Unveiling the Truths of Streamlined Clinical Research In the dynamic realm of clinical research, staying ahead of technological advancements is paramount. Consent management, a critical aspect of research, has witnessed a transformative shift with the advent of eConsent solutions. Despite their potential to streamline [...]
Contents Key Data Snapshot Predictions for 2024 Sponsor Tech Adoption Trends Barriers to Tech Investment Looking Ahead Next Steps Infographic: Top Emerging Trends 2024 State of Tech-Enabled Clinical Trials: Insights, Trends, and Predictions To kick off 2024, Ryan Jones, Catherine Gregor, and Blake Adams [...]
Ink to Link: Understanding the Potential of eConsent By Beau Bruneau, Senior Innovations Business Analyst, Florence Healthcare The research technology landscape is evolving at a remarkable pace, driven by innovations that aim to streamline site, sponsor, and CRO processes while enhancing the participant experience. Among these innovations, electronic informed consent (eConsent) has the potential [...]
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 [...]
ON-DEMAND WEBINAR Debunked: Myths and Misconceptions About eConsent Adoption Say goodbye to paperwork woes and hello to the future of streamlined processes! The digital revolution is reshaping the landscape, and we’re here to unravel the mysteries behind the lingering hesitation toward digitizing informed consent. Ready to dive in? In this webinar, you [...]
Navigating DCTs in a paper world By, Simon Taylor, Principal KOL & European Strategy Lead @ Florence What is a DCT? The Decentralised Trial (DCT) operating model offers a departure from the traditional "patient goes to site" approach. This novel approach improves patient access, especially for those who may have been [...]
Florence eConsent Overview: Electronic On-Site Informed Consent If you're tired of the disjointed, cumbersome processes that come with paper methods, then you're in the right place. With more and more participants choosing to sign their informed consent documents remotely with their electronic signature, now is the time to transform your clinical trial operations by leveraging [...]
Harnessing eConsent: A Stepping Stone Towards Survival for Cancer Centers By Catherine Gregor, Chief Clinical Trial Officer at Florence Healthcare Why Cancer Centers Need to Adopt Technology Now Clinical trials are an essential component of patient care in a number of diseases, but I would argue that nowhere are they more [...]
Overcoming Hurdles: Challenges of eConsent in Clinical Trials in Europe and How Florence's eConsent Can Help Introduction As electronic informed consent (eConsent) gains traction in clinical trials, researchers and sponsors face a multitude of challenges when implementing it within the European Union (EU). The complex regulatory landscape, cultural diversity, accessibility concerns, and [...]
Florence’s Compliance POV on eConsent in the U.S.A By Sara Saunders, Policy Manager at Florence Healthcare Florence eConsent enables users to take the traditional wet-ink consent process electronically, opening the door to remote consent workflows and more. In the US, requirements for the general consent process are outlined in 21 CFR parts [...]
Informed Consent Needs an Overhaul By Gunnar Esiason, Principal, Thought Leadership, Florence Like the fax machines still found in health systems around the country, the informed consent process inside clinical trials feels like an ode to an older generation. For those of us living with chronic terminal conditions, we want care delivery [...]
How eConsent Powers More Participant Engagement in Clinical Trials This article is written by Angela Gill Nelms and was originally published on medcitynews.com here. The chances are high that you have signed at least one consent document in your life. Consents are embedded into every part of our culture. Consent to use your [...]
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, [...]
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 [...]
As technology continues to transform Clinical Research operations, both research sites and sponsors are investigating ways to leverage this technology to make the most impact on their organizations and research as a whole. As a technology vendor ourselves, we often hear that organizations are continually approached by new technology vendors entering the market. This [...]
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 [...]
Clinical Trial Remote Monitoring and SOP Adjustments (2021) Today's crisis climate is creating a dichotomy in clinical research. On the one hand, researchers are experiencing major clinical research disruptions across the globe due to direct proximity to patients, priorities of healthcare workers, and a fragile overall healthcare ecosystem. As a result, sites are [...]
Free Download 37 Clinical Software Cloud Computing Terms Glossary A collection of terms and definitions related to cloud computing and areas of interest for Clinical Research organizations that are currently evaluating eClinical platforms and technologies. Download Glossary What you will [...]
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 [...]
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 [...]
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 [...]
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" [...]
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 [...]
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 [...]
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 [...]
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 [...]
