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 often expected sites to manage [...]
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 adopted Which solutions they’re considering for 2023 What tech capabilities they look for [...]
Since 2020, clinical research teams have radically changed how they approach clinical trial monitoring–and researchers need to adapt to this change to avoid being left behind. Before the pandemic, the most common type of monitoring was in-person monitoring, where Clinical Research Associates traveled by car or plane to each site to view their documents [...]
Patient retention in clinical trials is one of the largest challenges facing sites, sponsors, and CROs. The Center for Information and Study on Clinical Research Participation found that 23% of participants who enroll in a study don’t complete it. When a participant drops out of a study, the time spent identifying, consenting, screening, and [...]
When deciding on Clinical Research Coordinator (CRC) interview questions, research sites need to think about how the role is changing. Gone are the days when a Clinical Research Coordinator (CRC) only needed to fill out paper forms and meet with patients. CRCs today need to: Manage multiple technology systems Have a strong grasp of [...]
There are dozens of abbreviations for clinical trial terms. What’s the difference between a CRA, a CRC, and a CRO? How about the difference between eISF, ePRO, and eTMF? If you’ve been in medical research for years, these clinical trial abbreviations might come naturally to you–but if you’re just starting out in the industry, [...]
Ukraine clinical trials continue to suffer because of Russia’s invasion. When the war began, clinical trial activity had to be frozen. While some trials have resumed and some international trials continue to serve Ukrainian patients, the crisis raises an important question for clinical research teams: how do we support participants during a time of [...]
EU Annex 11 lays out the European Union’s regulations for using computerised systems during clinical trials. Any sponsor or site who wants their new medical treatment approved in the EU must follow Annex 11. In this post, we’ll answer the questions: What is Annex 11? Does Annex 11 apply to clinical trials? Does Annex [...]
CAR T-cell therapy clinical trials are among the most exciting medical advances of the past decade. Since 2017, the FDA has approved 6 CAR T-cell treatments for blood cancers, including lymphomas, some forms of leukemia, and multiple myeloma. CAR T-cell therapy offers hope for many patients who have relapsed or whose cancer hasn’t responded [...]
Florence Healthcare is committed to supporting Diversity, Equity & Inclusion (DE&I) initiatives in clinical trials, both through the use of its software and philanthropic investment in the community. Earlier this year, Florence's executive leadership reached out to their colleagues and asked how Florence could do more to support diversity initiatives at the local level. [...]
On Jan. 1, 2022, the Clinical Trial Treatment Act went into effect, requiring all U.S. states and territories to cover routine clinical trial costs for Medicaid patients. Medicaid coverage of clinical trials will bring access to the latest treatments to 81 million low-income Americans. For 12 years, Medicaid was the only major health insurer [...]
The site feasibility process is broken. The average clinical trial coordinator spends 264 hours a year completing feasibility questionnaires for sponsors. Yet 80% of clinical trial sites still don’t complete patient enrollment on time, and 11% of sites selected for a study never enroll a single patient. In addition to being inefficient and inaccurate, [...]
Historically, clinical trials have been concentrated at academic medical centers, large hospitals, and cancer centers. But under this approach, trials aren’t as inclusive or accessible as they should be. Bringing clinical trials to frontier sites–pharmacies, labs, doctors’ offices, and health clinics–can make clinical trials more accessible to thousands of patients. 70% of the U.S. [...]
When searching for clinical trial software, every site, sponsor and CRO has the same question: “how does this software comply with (insert clinical trial regulation here)?” Research professionals face an overwhelming number of regulations. In addition to international guidelines like ICH Good Clinical Practice, the Global Data Privacy Regulation (GDPR), or the EU Clinical [...]
Patient-facing technology can make trials more accessible and help trials fit into participants’ lives. But if we’re not careful, technology built to empower patients may end up overwhelming them instead. At the Research Revolution conference this November, we’ll be holding a panel on “Selecting Patient-facing Technology That Actually Works.” This panel will feature: Michelle [...]
The lack of diversity in clinical trials is one of the most pressing concerns confronting the clinical research industry. The recent FDA guidance for diversity in clinical trials calls on all clinical research sponsors and investigators to increase the racial and ethnic diversity of their trials, and many trials are also struggling to include [...]
When clinical trial sites, sponsors and tech vendors think about diversity and inclusion, we consider a variety of factors: age, race, ethnicity, gender identity, sexual orientation, ability, and more. But we often forget to think about the importance of language access and clinical trial translations, especially for trials originating in the U.S. A study [...]
The number of clinical trials has increased rapidly since 2020. 2021 saw a 14% increase in trial starts over 2020 and a 19% increase over 2019. And while 2020 was far from a typical year, the clinical trial industry is expected to see 5.8% annual growth every year from 2022-2030. Yet research sites are [...]
The number of new clinical trials is expected to increase 5.8% each year from 2022 to 2030. But research sites already struggle to keep up with trial workloads. With 1,015 new trials starting in Q4 2021 alone, many major research sites have a backlog of anywhere from 30 to 70 studies. These delays have [...]
It’s clear that remote work is here to stay. For industries like healthcare that have historically relied on in-person interactions and paper-based records, this means implementing new digital solutions to remain competitive. But the clinical trial industry is highly regulated and involves managing secure patient data. That means the software implementation process requires an [...]
A legally authorized representative (LAR) has a vital role to play in clinical trials, yet clinical trial software vendors too often forget to think about LARs and their needs. Most clinical research professionals have encountered patients who are in a coma or who have conditions like Alzheimer’s, dementia, serious mental illness, or developmental disabilities [...]
By Andrea Bastek, PhD, Senior Director of Innovation at Florence Whether you’re a Clinical Research Associate, Research Assistant, or Clinical Research Coordinator, working in the clinical trial industry isn’t easy. Most positions require detailed regulation, protocol, and disease state knowledge, attention to detail, and the ability to maintain meticulous documentation–not to mention project management, [...]
Clinical trials can’t avoid fluctuating economic conditions. Changes in the market can especially impact emerging and early-stage biotech companies with limited cash reserves. A clinical trial's fate can hang in the balance when funding conditions change, especially in early phases. In an informal survey of 43 CROs in June 2022, Florence found that: 57% [...]
The clinical trial industry has experienced 5.8% annual growth year over year–but the growth in Clinical Research Associates (CRAs) and research sites isn’t keeping up. To accommodate the number of trials predicted in 2030, Florence estimates that Contract Research Organizations (CROs) will collectively need to add 18,000 research sites to their networks. But as [...]
The FDA’s newest guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials,” took the clinical research world by storm. While diversity, equity, and inclusion have been major focuses for clinical research teams for a long time, sponsors and sites were excited and surprised to receive explicit [...]
Multinational clinical trials play an essential role in the European Union. In 2019 alone, Europe hosted 2,900 multinational trials. This was the second-highest number of clinical trials for any region of the world, only behind the Pacific. But multinational trials come with risks. First, multinational trials need to comply with regulations. The EU has [...]
Decentralized clinical trials (DCTs) –trials that don’t take place exclusively at major sites–have quickly grown in popularity. 89% of sponsors use DCT methods in some of their studies, and so do 92% of hospitals and health systems. But not everyone is excited about DCTs. Only 40% of academic medical centers use any DCT elements, [...]
By Taylor Davidson, Content Writer With special insights from Catherine Gregor, Chief Clinical Trials Officer, and Lauren Martin, Sr. Director of Customer Experience Investigator-initiated trials (IITs) make up nearly half of all clinical trials registered in online trial databases, and many government, industry, and nonprofit organizations fund IITs to find treatments for cancer, ALS, [...]
Wondering what’s next in the world of clinical research? Catherine Gregor, Florence’s Chief Clinical Trial Officer and the former Director of Clinical Research Administration at Vanderbilt, gathered this list of key trends in clinical research she noticed at ACRP 2022. Keep reading to discover 4 trends you need to know about to prepare for [...]
Tell me if this sounds familiar: a sponsor needs remote access to their sites, so they buy electronic Investigator Site Files (eISFs) and distribute them to their sites. Now the sponsor has access, and the sites have new platforms to hopefully speed up their work. However, some eISFs give sponsors unlimited access to sites’ [...]
Feasibility, diversity and inclusion, new FDA regulations, decentralization–ACRP 2022 will tackle the most exciting topics in clinical research, and we can’t wait to see you in person! Florence is proud to serve as one of the sponsors of ACRP 2022, and we want to make sure everyone who attends has an amazing time. Use [...]
Patient experience in clinical trials is a problem. On patient satisfaction surveys, clinical trials received low scores similar to the scores of Internet service providers, utility companies, and health insurers–businesses infamous for poor client experiences. A positive clinical trial experience encourages patients to participate in future trials and to recommend trials to their loved [...]
The Clinical Trials Regulation (CTR) for the EU took effect on 31 January 2022. Sites and sponsors must now embrace the new regulations to successfully run clinical trials across the European Union. To help, the European Commission (EC), Heads of Medicines Agencies (HMA), and European Medicines Agency (EMA) came together to create the Accelerating [...]
