Overcoming 4 Challenges in Multicenter Clinical Trials Efficiently managing multicenter clinical trials is an essential capability of the modern research center. Complex protocols often require diverse subjects spread across a vast network of research sites - increasing pressure on the coordinating center to streamline operations, maintain oversight, and avoid compliance risks. While the [...]
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 [...]
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 [...]
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: Blockchain and Clinical Trials Watch this on-demand webinar as our Chief Technology Officer explores the impact of Blockchain on Clinical Trials, and if you should be planning for it at your organization. Blockchain’s potential impact on the healthcare space is immense. The buzz surrounding blockchain technology is warranted and should [...]
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. [...]
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. [...]
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. However, nearly 80% of the sites we talk to have not yet implemented this time and cost savings workflow - why is this? The [...]
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) [...]
