Clinical Trial Monitoring is an essential element of the clinical trial process and a vital connection between the sponsor/CRO and the Research Site. Monitoring is the sponsor/CRO’s obligation to ensure that the Research Site conducts the trial per the protocol, SOPs, GCP, and any other regulatory requirements. Ultimately, when conducting an IND trial, regulations [...]
June 20, 2019, Atlanta, GA: Today Florence announced assignment of U.S. Patent No. 10,319,479 by the United States Patent and Trademark Office for: “Remote Monitoring and Dynamic Document Management Systems and Methods.” This patent covers how Florence’s applications process essential clinical trial documents—enabling a new approach to remote monitoring for Pharmaceutical companies, Medical Device [...]
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 [...]
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. [...]
While presenting at Central Monitoring Summit 2018, Elizabeth Robinson of Horizon Pharma shared a strong data point: In the coming years, Clinical Research Associates (CRAs) will experience more change to their jobs than any other research profession (2017 Applied Clinical Trials survey). This statement spurred a conversation amongst the room about what will change [...]
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 [...]
The Florence team just got back from the MAGI conference where we spoke on clinical trial site operational efficiency and the impact that monitoring queries have on sites. In our session and throughout the conference we heard the question: What is the difference between Risk-Based, Remote-Based, and Centralized Monitoring in clinical trials? Free White Paper - How Centralized Monitoring is Impacting [...]
