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Digitising Clinical Trials: How Technology Influences Sponsor Collaboration Technology has become a pervasive influence in multiple fields, bringing about significant changes that have fast-tracked progress. Clinical trial sites and sponsors that are not keeping up with technological changes are rapidly falling behind, increasing their risk of losing precious time, money, and resources. In our [...]
ON-DEMAND WEBINAR Going Digital: Overcoming Sponsor Resistance to Change Are paper forms and manual processes holding back your clinical research? Are you feeling the burden of capacity issues and inefficiency? Is your sponsor not as excited about transitioning from paper to digital processes? Don't let outdated methods slow you down! Watch this webinar [...]
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 [...]
How to Overcome Remote Monitoring Challenges in Clinical Research The global pandemic has shifted the clinical research ecosystem towards the rapid adoption of remote site monitoring. This shift has brought challenges for both monitors and sites trying to navigate new systems, processes, and regulations. Although remote monitoring enables easy site access, remote patient [...]
How Remote Monitoring Increases Regulatory Compliance for Your Studies This article was originally published on PharmaLive.com by Andrea Bastek, Director of Innovation at Florence. The rapid shift to remote site access and monitoring during COVID is beneficial to keeping study timelines on track and indicative of the future of clinical operations. However, this rapid innovation [...]
Free Download Understanding and Evaluating a Remote Site Access Solution for Monitoring and Source Data Verification in Clinical Trials An overview and checklist to successfully assess solutions that will modernize your entire approach to monitoring. Download the Guide Remote Access Capabilities [...]
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 [...]
Due to the growing obstacle of remote site access in clinical trials, technology vendors are flooding the market with remote monitoring clinical trial solutions to assist sponsors and CROs. As an Electronic Investigator Site File (eISF) + Remote Site Access technology vendor, we are experiencing first-hand the mass scramble of Sponsors and CROs looking [...]
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 [...]
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 [...]
Sites, sponsors, and CROs now perform the bulk of their clinical trial operations by logging into cloud-based systems. The rapid shift to digital document and data management solutions opened the door to innovative virtual collaboration solutions like Florence SiteLink™. Florence SiteLink provides sponsors and CROs direct digital connectivity and collaboration access with their sites [...]
How to Create a Digitally Connected Clinical Trial Ecosystem Sponsors and CROs' ability to access and collaborate with a research site is essential to the success of every study. Each study phase and clinical operations process requires the ability to access, review, and exchange documents efficiently and promptly. The speed and accuracy at [...]
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 [...]
Free Whitepaper Download Harness Site-based eISF Platforms to Accelerate Clinical Operations How Sponsors and CROs are turning-on remote site access, start-up, monitoring, and SDV to transform essential clinical trial processes. Download Whitepaper What you will learn: How remote site connectivity via [...]
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 Mitigate COVID-19 Disruptions while Ensuring Long-term Success with a Remote Document Management Strategy Build a strategy to overcome physical site-access disruption while building a foundation for long-term success that drives collaboration, accelerates research, expands trial access, and reduces cost. Download the Report [...]
Free Download 2020 Clinical Trial Technology State of the Industry Report Insights from the December 2019 Florence Annual State of the Industry Survey. Receive the Report What you will learn: How your peers are planning on utilizing technology in 2020 [...]
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. [...]
Free Download Complete Guide to Clinical Trial Monitoring Tips for conducting Clinical Trial Monitoring Visits throughout the life of a study, and insights into how technology is transforming the monitoring visit. Download Guide "Technology at the research site enables CRAs to spend [...]
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 [...]
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 [...]
Download: Competitive Advantages and Trends in Site Access to the eTMF Understand the trends in site access to the sponsor electronic trial master file (eTMF) and how new technology innovations are adding competitive advantages for sponsors who harness this industry advancement. The standard method of exchanging critical study documents with trial [...]
Watch: Best Practices for Multicenter Research Management with Technology Learn best practices, tips, and tricks for managing multicenter clinical trials with technology. Multicenter research introduces unique challenges and bottlenecks for clinical trial leaders who are expected to manage studies across sites. To avoid study delays and compliance risks when managing multi-site [...]
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 [...]
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 [...]
Watch: Remote Monitoring 101 Webinar Is your team prepared for the increasing shift to remote monitoring and oversight? Leading research teams are getting ahead of sponsor and CRO demands by establishing their remote monitoring strategies now that harness this shift to optimize their operations. View this recorded Florence webinar to learn: [...]
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 [...]
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. [...]
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: 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 [...]
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 [...]
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. [...]
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 [...]
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 [...]
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 [...]
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 [...]
This year we’ve met with 45 pharmaceutical, biotech, and device sponsors about both risk-based and remote-based monitoring (the combination referred to as RBM), and we’re seeing sponsors migrate to RBM in very different ways. We encountered three main RBM positions: Source: Florence HC industry interviews, 2015 Targeted. 50% have moved [...]
This year we’ve met with 45 pharmaceutical, biotech, and device sponsors about both risk-based and remote-based monitoring (the combination referred to as RBM), and we’re seeing sponsors migrate to RBM in very different ways. We encountered three main RBM positions: Source: Florence HC industry interviews, 2015 Targeted. 50% have moved [...]
This Post Originally Published in 2017, Updated in April 2021 The Florence team just got back from the MAGI conference where we spoke on clinical trial site operational efficiency and the impact that monitoring queries have on sites. In our session and throughout the conference we heard the question: What is the difference between Risk-Based, Remote-Based, and Centralized Monitoring [...]
This Post Originally Published in 2017, Updated in April 2021 AfteThe Florence team just got back from the MAGI conference where we spoke on clinical trial site operational efficiency and the impact that monitoring queries have on sites. In our session and throughout the conference we heard the question: What is the difference between Risk-Based, Remote-Based, and Centralized Monitoring [...]
Is Risk Based Monitoring a help? Depends on where you sit in the clinical trial process. For example, in a recent Wall Street report, a CRO boasts: “20,000 sites and 250,000 patients now remotely monitored using award winning technology.” Meanwhile, the Florence Healthcare team met with dozens of sites around the world this quarter, and [...]
