Contents Updates to ICH E6(R3) Decentralized Clinical Trials Good Data Governance Practice Future of Inspections 4 Compliance Takeaways from the Joint US-FDA, MHRA-UK, and Health Canada GCP Symposium The Florence Compliance Team joined the Joint US-FDA, MHRA-UK, Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium in February 2024 [...]
Impact of ICH E6 R3 on Clinical Trials ICH E6(R3) was written to incorporate more flexibility into Good Clinical Practice (GCP) guidelines, with the authors acknowledging that as trials become more diverse, the principles that support their conduct need to as well. In planning for R3, ICH noted that it intended to address the [...]
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 [...]
ICH E6 R(3) - What Does It Mean for the Future of Site Enablement? By, Simon Taylor, Principle KOL & European Strategy Lead @ Florence The latest updates to the ICH R6 E3 that are currently out for public consultation contain some big changes in the way clinical research is run. In this [...]
FDA Part 11 New Draft (March 2023) Guidance By Sara Saunders, Policy Manager at Florence Healthcare In March, the FDA posted a new draft guidance on Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations to provide additional recommendations regarding the requirements under 21 CFR Part 11. When in effect, this guidance [...]
Designing more Diverse and Inclusive Trials:Understanding the FDAs guidance on diversity and the intersection with technology Let's Cure ClinicalTrials Together Request Demo
HIPAA Guidance on Technology and Clinical Research Over 46 pages with 100+ questions sourced from the US Department of Health and Human Services HIPAA FAQ for Professionals focused on technology and clinical research. As it is our mission at Florence to help research sites, sponsors and CROs take their day back from paper, [...]
Tips for Managing Data Protection and Data Privacy in Clinical Trials Technology continues to play a larger role in clinical trials, and subsequently, regulatory bodies are placing intense scrutiny on data protection and data privacy in clinical trial procedures and policies. Learning all of the new jargon and terminology related to electronic data protection [...]
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 [...]
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 [...]
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, [...]
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 Your eRegulatory Action Plan Interactive guide on how to cultivate successful evaluation, selection and implementation of eRegulatory at your organization Download Action Plan What you will learn: Identify unique operational bottlenecks and organizational goals Select proper clinical software [...]
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 [...]
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 [...]
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 [...]
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 [...]
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. [...]
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. [...]
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. [...]
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. [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
