19 05, 2023

FDA Part 11 New Draft (March 2023) Guidance

2023-05-19T12:52:52-04:00

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New Draft (March 2023) Guidance By Sara Saunders, Policy Manager at Florence Healthcare In March, the FDA posted a new draft guidance on Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations to provide additional recommendations regarding the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 [...]

FDA Part 11 New Draft (March 2023) Guidance2023-05-19T12:52:52-04:00
16 05, 2023

How a Clinical Trial Participant Would Use a Magic Wand to Reform Future Clinical Trials

2023-05-16T20:47:48-04:00

How a Clinical Trial Participant Would Use a Magic Wand to Reform Future Clinical Trials By Gunnar Esiason, Principal Key Opinion Leader of Patient Strategy at Florence Healthcare A few weeks ago, I came across an article that detailed the reforms life sciences executives would make to clinical trials if given a magic [...]

How a Clinical Trial Participant Would Use a Magic Wand to Reform Future Clinical Trials2023-05-16T20:47:48-04:00
9 05, 2023

Digitising Research in the NHS

2023-05-09T19:13:11-04:00

Digitising Research in the NHS Improving Research within the NHS By Simon Taylor, Head of European Solution Consulting ‘The first place it’s written down is the first place it’s documented.’ - Co-ordinators, everywhere If it's not documented, it didn’t happen. The problem is, WHERE it’s first documented matters as much as [...]

Digitising Research in the NHS2023-05-09T19:13:11-04:00
9 05, 2023

Florence’s Compliance POV on eConsent in the USA

2023-05-09T17:48:09-04:00

 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 [...]

Florence’s Compliance POV on eConsent in the USA2023-05-09T17:48:09-04:00
8 05, 2023

Ensuring Business Continuity in Clinical Trials: The Power of Site Enablement Platforms as an Insurance Policy

2023-05-09T13:08:25-04:00

Ensuring Business Continuity in Clinical Trials: The Power of Site Enablement Platforms as an Insurance Policy Introduction Today's clinical trials are complex, often encompassing multiple countries and hundreds of research sites. In this fast-paced, interconnected world, pharmaceutical and Contract Research Organization (CRO) industries must anticipate and prepare for challenges that could threaten business [...]

Ensuring Business Continuity in Clinical Trials: The Power of Site Enablement Platforms as an Insurance Policy2023-05-09T13:08:25-04:00
8 05, 2023

Breaking Down the FDA’s Draft Guidance on Decentralized Clinical Trials: 7 Key Insights That Matter Today

2023-05-08T12:54:23-04:00

Breaking Down the FDA’s Draft Guidance on Decentralized Clinical Trials: 7 Key Insights That Matter Today By Catherine Gregor, Chief Clinical Trial Officer at Florence Healthcare On May 1, 2023, the FDA released new guidance for decentralized clinical trials (DCTs), clarifying regulatory requirements and helping to pave the way for more widespread adoption [...]

Breaking Down the FDA’s Draft Guidance on Decentralized Clinical Trials: 7 Key Insights That Matter Today2023-05-08T12:54:23-04:00
5 05, 2023

A Site Point of View into Study Start-up

2023-05-05T17:41:48-04:00

A Site Point of View into Study Start-up How do study start up times affect your site? Probably in far more ways than you tend to think! Elongated startup durations impede operations, negatively affect a site’s bottom line, and most importantly, delay access to potentially life-changing therapies for patients.  Start-up timelines have always [...]

A Site Point of View into Study Start-up2023-05-05T17:41:48-04:00
5 05, 2023

Top 5 Takeaways from ACRP from a Site Enablement Perspective

2023-05-05T17:26:32-04:00

Top 5 Takeaways from ACRP from a Site Enablement Perspective Last week, over the course of three days, hundreds of clinical research professionals gathered in Dallas, Texas, for the 2023 Association of Clinical Research Professionals (ACRP) Conference.  There were several tracks, or “journey” options, that attendees could take. One of these journeys was [...]

Top 5 Takeaways from ACRP from a Site Enablement Perspective2023-05-05T17:26:32-04:00
28 04, 2023

Informed Consent Needs an Overhaul

2023-05-01T19:35:28-04:00

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 [...]

Informed Consent Needs an Overhaul2023-05-01T19:35:28-04:00
28 04, 2023

What You Need to Know About Using an eTMF and eISF in China

2023-05-01T19:28:05-04:00

What You Need to Know About Using an Electronic Trial Master File (eTMF) and Electronic Investigator Site File (eISF) in China for Clinical Trials In recent years, there has been an increase in clinical trial activity in China. At Florence, our mission is to advance cures for diseases and therefore we have been [...]

What You Need to Know About Using an eTMF and eISF in China2023-05-01T19:28:05-04:00
20 04, 2023

Revolutionizing Clinical Trials with eTMF: The Ultimate Guide to Streamlining Document Management

2023-04-20T17:23:47-04:00

Revolutionizing Clinical Trials with eTMF: The Ultimate Guide to Streamlining Document Management The Electronic Trial Master File (eTMF) is rapidly transforming the landscape of clinical trials by simplifying document management, improving data accuracy, and enhancing collaboration among research teams. As the demand for efficient clinical trial management continues to grow, eTMF systems have [...]

Revolutionizing Clinical Trials with eTMF: The Ultimate Guide to Streamlining Document Management2023-04-20T17:23:47-04:00
28 03, 2023

How to Embrace Technology and Drive Change with Florence’s Approach to Site Enablement

2023-04-16T17:13:43-04:00

How to Embrace Technology and Drive Change with Florence’s Approach to Site Enablement The clinical trial industry has experienced about 6% growth, year over year, as well as greater study complexity, causing a 70% increase in tasks required in Phase III Trials. Unprecedented stress has been put on sites as they’re expected to maintain [...]

How to Embrace Technology and Drive Change with Florence’s Approach to Site Enablement2023-04-16T17:13:43-04:00
23 03, 2023

A Comprehensive Guide to the EMA’s Guidelines on Computerized Systems and Electronic Data Management in Clinical Trials

2023-04-16T17:14:37-04:00

A Comprehensive Guide to the EMA's Guidelines on Computerized Systems and Electronic Data Management in Clinical Trials Clinical trials are crucial to the development and approval of new medications. Ensuring data integrity and patient safety throughout the process is a top priority. To address this, the European Medicines Agency (EMA) has issued guidelines for [...]

A Comprehensive Guide to the EMA’s Guidelines on Computerized Systems and Electronic Data Management in Clinical Trials2023-04-16T17:14:37-04:00
23 03, 2023

Key Changes in the EMA’s Updated Guidelines for Computerized Systems and Electronic Data in Clinical Trials

2023-04-16T17:15:42-04:00

Key Changes in the EMA's Updated Guidelines for Computerized Systems and Electronic Data in Clinical Trials The European Medicines Agency (EMA) periodically revises its guidelines to ensure that they remain relevant and up-to-date with the latest advancements in technology and industry best practices. In this blog post, we will discuss the key changes [...]

Key Changes in the EMA’s Updated Guidelines for Computerized Systems and Electronic Data in Clinical Trials2023-04-16T17:15:42-04:00
23 03, 2023

FDORA-Omnibus Act 2022: Implications for Clinical Trials and Healthcare

2023-04-16T17:17:19-04:00

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 [...]

FDORA-Omnibus Act 2022: Implications for Clinical Trials and Healthcare2023-04-16T17:17:19-04:00
10 03, 2023

Three Critical Factors Essential to the Evolution of Clinical Research Sites in the EU

2023-04-16T17:21:20-04:00

Three Critical Factors Essential to the Evolution of Clinical Research Sites in the EU The clinical research industry is evolving, especially when it comes to the adoption of technology. One of the first steps in making an impactful technology decision at your organisation is understanding the factors at play within the industry, including [...]

Three Critical Factors Essential to the Evolution of Clinical Research Sites in the EU2023-04-16T17:21:20-04:00
6 03, 2023

Innovation Summit Recap: Reducing the Chaos of Technology Vendor Overload in Clinical Research

2023-04-16T17:24:12-04:00

Innovation Summit Recap: Reducing the Chaos of Technology Vendor Overload in Clinical Research The breakneck pace of new technology vendors entering the clinical trials space was the key focus during Florence's Q1 Innovation Summit, hosted by Florence’s Innovations Team of Andrea Bastek, PhD and Beau Bruneau. Innovative leaders from sites, sponsors, CROs and [...]

Innovation Summit Recap: Reducing the Chaos of Technology Vendor Overload in Clinical Research2023-04-16T17:24:12-04:00
27 02, 2023

Investigator-Initiated Trials Didn’t Bounce Back After COVID-19, What Can We Do About It?

2023-04-16T17:26:03-04:00

Investigator-Initiated Trials Didn’t Bounce Back After COVID-19, What Can We Do About It? Having worked in the clinical research industry for 15+ years, I've seen a lot of obstacles come our way in the effective operations of clinical trials. Most recently, the Great Resignation has impacted our capacity as an industry, though investigator-initiated [...]

Investigator-Initiated Trials Didn’t Bounce Back After COVID-19, What Can We Do About It?2023-04-16T17:26:03-04:00
26 02, 2023

Breaking Down Barriers: Why Closed Technology Ecosystems are Holding Back Clinical Research

2023-04-16T22:04:17-04:00

Breaking Down Barriers: Why Closed Technology Ecosystems are Holding Back Clinical Research This is the first in a series of posts from Florence's Chief Clinical Trial Officer Andres Garcia on building better software for clinical trial operations. The clinical research industry is complex, and as it evolves, so do the challenges we face. [...]

Breaking Down Barriers: Why Closed Technology Ecosystems are Holding Back Clinical Research2023-04-16T22:04:17-04:00
24 02, 2023

Six Ways Sponsors and CROs Optimize Site Performance Using Florence’s Site Activity Dashboard

2023-04-16T22:06:50-04:00

Six Ways Sponsors and CROs Optimize Site Performance Using Florence’s Site Activity Dashboard Clinical trial management can be a daunting task, especially when you need to ensure that all your study sites are performing as they should. With so many moving parts, it can be challenging to keep track of all the necessary [...]

Six Ways Sponsors and CROs Optimize Site Performance Using Florence’s Site Activity Dashboard2023-04-16T22:06:50-04:00
20 02, 2023

Accelerating Clinical Research: 5 Ways Florence Healthcare’s Mobile App Helps Sites Get Work Done Faster

2023-04-16T22:06:37-04:00

Accelerating Clinical Research: 5 Ways Florence Healthcare's Mobile App Helps Sites Get Work Done Faster Saving time is crucial in clinical research. Falling behind schedule can delay regulatory approvals, miss patient recruitment opportunities, and even result in intellectual property loss. That's why it's so important to streamline workflows and eliminate unnecessary delays. Florence [...]

Accelerating Clinical Research: 5 Ways Florence Healthcare’s Mobile App Helps Sites Get Work Done Faster2023-04-16T22:06:37-04:00
16 02, 2023

The Top 5 Takeaways from SCOPE Summit: Shifting Power Dynamics, Site Enablement, and More

2023-04-16T22:06:25-04:00

The Top 5 Takeaways from SCOPE Summit: Shifting Power Dynamics, Site Enablement, and More Last week, the annual SCOPE Summit brought together leaders in the clinical research industry to discuss the latest trends and challenges.  The conference highlighted the shifting power dynamic in clinical research, with sites now at the top of the [...]

The Top 5 Takeaways from SCOPE Summit: Shifting Power Dynamics, Site Enablement, and More2023-04-16T22:06:25-04:00
6 02, 2023

Site, Sponsor, and Mobile Technologies in Clinical Trials: The Technology Landscape

2023-04-16T22:06:01-04:00

Site, Sponsor, and Mobile Technologies in Clinical Trials: The Technology Landscape More than 250 companies create site, sponsor, and mobile technologies for clinical trials. Choosing between that many platforms can be overwhelming, especially when the average clinical research team already logs into six software platforms for every study.  Yet technology also has tremendous [...]

Site, Sponsor, and Mobile Technologies in Clinical Trials: The Technology Landscape2023-04-16T22:06:01-04:00
25 01, 2023

What Is Site Enablement?

2023-04-16T22:07:43-04:00

What Is Site Enablement? Site Enablement refers to any technology that prioritizes the needs of clinical research sites. Site Enablement Platforms connect sites, sponsors, and CROs to enable continuous collaboration throughout the clinical trial process.  The rise of Site Enablement marks a major shift in the clinical trial industry. In the past, sponsors [...]

What Is Site Enablement?2023-04-16T22:07:43-04:00
11 01, 2023

Clinical Trial Technology Report Showcases 2023 Trends: Site Enablement, eISFs, and Integrations

2023-05-18T10:22:24-04:00

Clinical Trial Technology Report Showcases 2023 Trends: Site Enablement, eISFs, and Integrations Florence Healthcare just released the 2023 State of Clinical Trial Technology Report, with dozens of insights from more than 450 clinical research sites, sponsors, and CROs.  We asked these clinical research leaders questions like: What clinical trial technology platforms they’ve already [...]

Clinical Trial Technology Report Showcases 2023 Trends: Site Enablement, eISFs, and Integrations2023-05-18T10:22:24-04:00