AI-Powered Contracting: Unlocking Speed and Precision in Clinical Trials
Claire O'Neill2025-05-30T09:36:06-04:00AI-Powered Contracting: Unlocking Speed and Precision in Clinical Trials
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05, 2025
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04, 2025
Unlock Faster, Smarter Trials: 5 Reasons to Choose an eTMF with Remote Site Access
Lautel Okhio2025-05-06T08:49:13-04:00Article Unlock Faster, Smarter Trials: 5 Reasons to Choose an eTMF with Remote Site Access Managing clinical trial sites can often feel like navigating a maze of emails, document requests, and compliance checks. But integrating Remote Site Access (RSA) into your electronic Trial Master File (eTMF) platform can [...]
21
04, 2025
Earth Day 2025: How Technology is Reducing Clinical Trials’ Carbon Footprint While Bringing Patients Closer to Care
Lautel Okhio2025-04-23T15:41:46-04:00Article Earth Day 2025: How Technology is Reducing Clinical Trials’ Carbon Footprint While Bringing Patients Closer to Care As we celebrate Earth Day this year, it’s the perfect time to reflect on how innovation isn’t just improving lives—it’s helping protect our planet. At Florence Healthcare, we believe in [...]
11
04, 2025
Five Ways Site-Facing Technology Helps Sponsors and CROs Accelerate Clinical Trials
Lautel Okhio2025-04-11T16:11:05-04:00Article Five Ways Site-Facing Technology Helps Sponsors and CROs Accelerate Clinical Trials In order to accelerate clinical trials, pharmaceutical sponsors and CROs are constantly striving for faster time-to-market, inspection readiness, greater team efficiency, and lower costs. But while many focus on data, timelines, and budgets, there’s a crucial [...]
26
03, 2025
What does TMF Health Really Mean?
Lautel Okhio2025-03-26T14:15:02-04:00Article What does TMF Health Really Mean? We know that building a healthy TMF is critical for accelerating clinical trials, but what does it really mean to build a healthy eTMF? When you digitize the processes that build your TMF file, does anything really change? Is it all [...]
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03, 2025
How the eISF Has Changed and What You Need to Stay Ahead
Tracy Howard2025-03-26T13:22:41-04:00ON-DEMAND WEBINAR How the eISF Has Changed and What You Need to Stay Ahead Your eISF/eRegulatory solution should be keeping up with your research. A lot has changed in the last few years of how an eISF can support your studies, and organizations are migrating systems without disrupting their operations. In [...]
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03, 2025
eTMFs Uncovered: 5 Costly Misconceptions To Avoid
Lautel Okhio2025-03-07T14:25:28-05:00eTMFs Uncovered: 5 Costly Misconceptions To Avoid In the realm of logistics and navigating sites’ eISF, there are few things more important than the eTMF. Organizations are inundated with technology that claims to make the building of the eISF and the integration of it into the eTMF easier, but not all eTMFs are [...]
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03, 2025
Navigating Canadian eRegulations and Clinical Trials Landscape
Maddie Page2025-03-06T11:56:16-05:00ON-DEMAND WEBINAR Navigating Canadian eRegulations and Clinical Trials Landscape The regulatory landscape in Canada is changing—are you prepared? This webinar breaks down the latest updates in clinical trial compliance, privacy laws, and regulatory frameworks affecting sponsors, sites, and CROs. What you’ll learn: ✅ The impact of Quebec’s Law 25 and upcoming [...]
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02, 2025
10 Game-Changing Features You May Have Missed in Florence eBinders
Lautel Okhio2025-02-27T15:29:13-05:0010 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 [...]
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02, 2025
Choosing the Best Platform for Enrollment Automation Checklist
Maddie Page2025-02-10T11:23:10-05:00FREE DOWNLOAD Choosing the Best Platform for Enrollment Automation Checklist Selecting the right participant enrollment platform is critical to optimizing recruitment and trial management. This comprehensive checklist provides a structured approach to evaluating solutions, ensuring you choose a platform that enhances efficiency, participant engagement, and compliance. You’ll gain a clear framework [...]
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02, 2025
How Sites can ensure they are aligned with ICH E6 R3
Lautel Okhio2025-02-19T10:52:45-05:00How Sites can ensure they are aligned with ICH E6 R3 The long-anticipated finalization of the ICH Good Clinical Practice (GCP) E6 R3 was achieved on January 6, 2025, marking a milestone in global clinical research. The principles and Annex 1 of ICH E6(R3) have reached Step 4 and are transitioning into Step [...]
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01, 2025
Large Multi-Site Cancer Center Ensures Compliance and Audit Success with Florence’s eBinders
Maddie Page2025-01-29T12:04:14-05:00Large Multi-Site Cancer Center Ensures Compliance and Audit Success with Florence’s eBinders Let's Cure Clinical Trials Together Request Demo
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01, 2025
Accelerating Trial Timelines: How a Large Multi-Site Network Streamlined Study Startups with Integrated Solutions
Maddie Page2025-01-29T12:03:20-05:00Accelerating Trial Timelines: How a Large Multi-Site Network Streamlined Study Startups with Integrated Solutions Let's Cure Clinical Trials Together Request Demo
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11, 2024
Transforming Research Operations in NHS Hospitals
Maddie Page2024-11-12T14:39:34-05:00Transforming Research Operations in NHS Hospitals https://online.flippingbook.com/view/869426928/ Let's Cure Clinical Trials Together Request Demo
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10, 2024
The Final DCT Guidance: I’m Not Mad at It
Lautel Okhio2024-10-16T12:04:44-04:00The Final DCT Guidance: I’m Not Mad at It By Catherine Gregor, Chief Clinical Trial Officer at Florence Healthcare The FDA recently released its final guidance on the conduct of Decentralized Clinical Trials (DCTs), and I, for one, couldn’t be happier with the results. This latest guidance marks a significant improvement over [...]
23
09, 2024
Busting Myths About Remote Monitoring and Document Automation
Lautel Okhio2024-10-16T12:06:59-04:00Busting Myths About Remote Monitoring and Document Automation Remote Monitoring and Document Automation are two proven areas where Sponsors, CROs and Sites can significantly reduce costs while improving operational efficiency. However, despite the clear benefits, there are still several myths surrounding remote monitoring and document automation. Our CEO Ryan Jones addressed a few [...]
20
09, 2024
How Remote Monitoring and Document Automation Can Reduce Site Management Costs
Lautel Okhio2024-10-16T14:13:36-04:00How Remote Monitoring and Document Automation Can Reduce Site Management Costs In our recent webinar on how remote monitoring can reduce costs by as much as 25%, we explored how technology can optimize clinical trials, addressing common myths and demonstrating tangible cost savings. In today’s ever-evolving clinical trial landscape, one of the most [...]
20
09, 2024
Site Study Start Up Checklist
Maddie Page2024-11-28T15:36:39-05:00Free Download Research Study Start-Up Checklist: Site Perspective This free checklist is designed to give you the tools you need to navigate the chaos of clinical trial initiation. With shorter study start-up timelines being the holy grail for sponsors and CROs, it’s critical to: Understand what you’re getting into. Establish proficient [...]
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08, 2023
On-Site Electronic Consenting Overview
Elise Gordon2024-11-27T17:12:32-05:00Florence 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 [...]
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02, 2023
An Overview of Florence’s Site Enablement Platform for Sites
Blake Adams2023-04-20T21:21:48-04:00An Overview of Florence's Site Enablement Platform for Sites https://online.flippingbook.com/view/594363454/ Let's Cure Clinical Trials Together Request Demo
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07, 2021
Proving The Return on Investment of eRegulatory for Research Sites
Blake Adams2024-12-01T22:36:03-05:00Discover the True ROI of eRegulatory in Clinical Trials Are you ready to optimize your clinical trial processes and maximize return on investment (ROI)? Introducing our FREE guide, "Proving the ROI of eRegulatory," crafted to help you understand and leverage the benefits of eRegulatory solutions in clinical research. With this information-packed guide, you'll [...]
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02, 2021
Florence Healthcare Announces Launch of “The Next Phase” Podcast
Blake Adams2022-12-09T15:21:09-05:00ATLANTA,GA - February 18, 2021 -(BUSINESS WIRE)--Florence, the largest site and sponsor connectivity platform in clinical research, announces today the launch of a new podcast series, “The Next Phase: Exploring Innovations in Clinical Trials.” Inspired by the industry’s gaps and issues exposed during the Covid-19 crisis, the podcast focuses on the need for sites, sponsors [...]
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01, 2021
Beginners Guide to GDPR for Clinical Trials
Blake Adams2025-02-10T16:44:15-05:00Beginners 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 [...]
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10, 2020
Remote Clinical Monitoring | 4 Tips to Get CRA and Site Adoption
Blake Adams2021-03-18T12:25:50-04:00Four 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 [...]
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07, 2020
Webinar: The Future of Remote Site Access and Virtual Monitoring
Blake Adams2024-12-02T11:32:48-05:00Watch: 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 [...]
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05, 2020
Florence Clinical Trial Research Network Hits Milestone
Blake Adams2022-10-31T17:08:23-04:00Florence Clinical Trial Research Network Hits Milestone in Remote Site and Sponsor Connectivity ATLANTA, GA - May 19th, 2020 - Today, Florence announces its rapidly expanding clinical research sponsor and site connectivity platform is now in use at more than 7,200 research sites and by 18,000 research professionals across 27 countries – making it [...]
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02, 2020
Webinar Recording: eISF Reference Model Overview
Blake Adams2024-12-02T11:55:28-05:00Florence Recorded Webinar: eISF Reference Model Overview Download eISF Reference Model Florence eBinders eISF Power your research operations by moving your Investigator Site File to the eISF Standard - Florence eBinders. Over 6,200 active sites trust our intuitive platform to help them accelerate research. [...]
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02, 2020
Announcing Shared Investigator Platform (SIP) Collaboration
Blake Adams2020-02-28T10:45:33-05:00Announcing Florence Collaboration with Shared Investigator Platform (SIP) Orlando, FL, February 24, 2020 (Newswire.com) - Last week at SCOPE Summit Florence announced a strategic collaboration with Cognizant. The collaboration aims to accelerate clinical research by integrating its industry-leading Florence eBinders Electronic Investigator Site File (eISF) platform with the Cognizant Shared Investigator Platform (SIP). The two companies announced [...]
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02, 2020
How the MAGI eISF Reference Model Will Impact Your Work
Blake Adams2023-04-16T23:19:01-04:00eISF 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 [...]
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02, 2020
Announcing Global eISF Reference Model
Blake Adams2022-12-09T15:07:30-05:00ATLANTA, February 10, 2020 (Newswire.com) -Florence, an Atlanta-based clinical trial software company, today announces the introduction of v0.9 of the Global Electronic Investigator Site File (eISF)/eRegulatory Binder Reference Model. This reference model was developed in collaboration with WCG MAGI and numerous clinical research technology experts to ensure interoperability between eISF platforms, eTMFs, and other systems. [...]
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02, 2020
7 Actionable Tips for Seamless Software Implementation
Blake Adams2023-04-16T23:19:10-04:00Selecting the right eRegulatory platform with the features you need is only half the equation; the other half is successfully implementing the platform at your research organization. In this guest article, Yvonne Gorham shares her tips for successful eRegulatory implementations. Yvonne has over 20 years of clinical research operations experience and helped navigate the [...]
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02, 2020
Guide to Change Management
Blake Adams2021-06-16T09:19:44-04:00Download: Guide to Successful Change Management in Clinical Trials Your guide to building a successful organizational change management plan that maximizes return on investment of new clinical trial technology. Purchasing the right software solution for your research site is only half the battle. The other half – and arguably the more important [...]
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02, 2020
eISF Reference Model
Blake Adams2020-12-01T13:35:35-05:00Download: Electronic Investigator Site File (eISF) Reference Model The Electronic Investigator Site File (eISF) Reference Model, developed in collaboration with WCG MAGI and all leading Electronic Investigator Site File (eISF) vendors, is the standard template for setting up the eISF at the research site and maps directly to the TMF Reference Model. [...]
16
01, 2020
Florence Doubles Number of Clinical Research Teams Using Its Platform
Blake Adams2022-12-09T15:17:45-05:00Atlanta, GA, January 16, 2020 (Originally Published at Newswire.com) - Florence, an Atlanta-based clinical trial software company, today announces that it doubled the number of Research Teams using Florence eBinders to accelerate clinical trial workflows in 2019. “Our mission is to accelerate cures with technology, and we believe the best way to do that is [...]
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12, 2019
Webinar Recording | 2020 State of the Industry
Blake Adams2024-12-02T11:23:14-05:00Watch: 2020 State of the Industry Webinar 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. As you prepare for 2020, it is essential to ensure you are focusing on the right priorities, especially [...]
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12, 2019
Download | 2020 State of the Industry
Blake Adams2021-06-16T09:04:20-04:00Free 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 [...]
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10, 2019
Webinar Recording | eRegulatory One Year Later
Blake Adams2024-12-02T11:58:13-05:00Watch: eRegulatory: One Year Later Listen to this recording of our guest panel of clinical trial site representatives discussing the realities of implementing an eRegulatory solution. During this webinar research organizations like Moffitt Cancer Center and the University of Arizona Cancer Center shared first-hand stories of implementing eRegulatory including: What benefits [...]
12
09, 2019
Over 7,300 Clinical Researchers on Florence eISF Platform
Blake Adams2022-12-09T15:29:19-05:00Atlanta, GA, September 12, 2019 (Newswire.com) - Today, Florence announced over 7,300 clinical researchers now conduct clinical trials through its innovative Electronic Investigator Site File (eISF), Florence eBinders - a growth of more than 200% this year. “The number of teams worldwide now managing their eISF with Florence is representative of our focus on making the best possible [...]
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08, 2019
Why Remote Clinical Trial Monitoring is the New Standard
Blake Adams2023-05-03T21:55:04-04:00Why 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. [...]
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08, 2019
Webinar Recording | eTMF + eISF Integrations: Why and Why Now?
Blake Adams2024-12-02T11:58:40-05:00Watch: 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 [...]
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06, 2019
Technology in Multicenter Clinical Trials
Blake Adams2023-05-03T21:58:23-04:00Managing 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 [...]
22
04, 2019
FDA: Technology’s Value in a World of Precision Medicine and Research
Blake Adams2023-05-03T21:58:32-04:00Over 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 [...]
12
02, 2019
5 Key Advantages of eRegulatory
Blake Adams2024-12-02T12:50:15-05:00Over 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 [...]
18
01, 2019
How Lauren Begnaud Transitioned 65 Sites to eRegulatory at US Oncology
Blake Adams2021-05-20T11:21:24-04:00In 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 [...]
28
12, 2018
Thank you for a great 2018!
Blake Adams2022-10-31T12:03:41-04:00What 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 [...]
19
12, 2018
Key Expectations of Clinical Trial Operations Leaders in 2019
Blake Adams2021-05-20T10:55:14-04:00Today’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 [...]
24
10, 2018
Four Observations from Site Solutions Summit
Ryan Jones2021-05-20T10:46:49-04:00This 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 [...]
12
09, 2018
Ten Ways Florence eBinders™ Accelerates Study Startup
Blake Adams2021-05-20T10:36:27-04:00Moving 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 [...]
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08, 2018
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08, 2018
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08, 2018
Ten Must-Have Capabilities When Evaluating eRegulatory Platforms
Blake Adams2021-05-20T10:17:46-04:00Successfully 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 [...]
14
06, 2018
Webinar | Avoiding Digital Site Surprises
Blake Adams2024-12-02T13:37:33-05:00Recorded 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 [...]
13
06, 2018
How to Avoid the Top 5 Clinical Trial FDA Inspection Failures
Blake Adams2021-05-20T10:00:32-04:00Your 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. [...]
15
05, 2018
10 Superpowers of Clinical Trial Leaders
Blake Adams2021-07-27T20:20:36-04:00While 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" [...]
1
05, 2018
5 Things to Know about Blockchain and Clinical Trials
Florence Team2021-05-20T09:44:33-04:00“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 [...]
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03, 2018
How to Use Electronic Signatures (eSignatures) in Clinical Trials
Florence Team2021-05-19T19:00:10-04:00Electronic 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 [...]
12
03, 2018
Cancer Research Is Accelerating, But We Can Do Better
Ryan Jones2021-05-19T18:51:32-04:00The 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. [...]
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02, 2018
Innovations | The time is now for eRegulatory and eSource
Florence Team2021-05-19T18:40:00-04:00Innovation 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 [...]
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01, 2018
“I have too many systems!” | The Top 4 Integrations You Need
Florence Team2021-05-19T18:31:00-04:00New 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 [...]
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11, 2017
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11, 2017
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10, 2017
Your Roadmap to eRegulatory: Define Eight Critical Workflows
Florence Team2021-05-19T18:25:03-04:00Transitioning 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. [...]
25
10, 2017
Your Roadmap to eRegulatory: Establishing Goals
Florence Team2021-05-19T17:57:10-04:00Transitioning 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 [...]
14
07, 2017
5 Ways To Engage Clinical Trial Sites With Technology
Ryan Jones2021-05-19T17:49:13-04:00As 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 [...]
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03, 2017
Can I control access with electronic binders?
Blake Adams2021-05-19T17:37:27-04:00You’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 [...]
24
02, 2017
What’s Your eRegulatory Strategy?
Ryan Jones2021-05-19T17:03:28-04:00What’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) [...]
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12, 2016
What if I get audited?
Florence Team2021-05-19T16:56:56-04:00A 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 [...]
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12, 2016
“My PIs are super busy and unable to try new things! How can I convince them to try eBinders?”
Florence Team2021-05-19T16:50:18-04:00Research 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 [...]