Florence Healthcare recently published its Status of clinical trial Technology Industry report. The study of more than 230 clinical operations professionals confirmed what the industry has seen over the past 10 months – COVID has forced organizations to accelerate their technology transformation plans, and investments in technology will only come to pass. ‘accelerate over the next three years. Florence Healthcare, a platform for electronic document and data flow management and remote connectivity in clinical trials, is the remote clinical trial software that actively supports the global COVID-19 vaccine study of Pfizer. Blake Adams, vice president of marketing at Florence Healthcare, discusses some of the report’s key findings, as well as the clinical trial software used to support Pfizer’s global COVID-19 vaccine study. –KB Contract Pharma: What are some of the main conclusions of the state of the clinical trial? Technology Industry report? Blake Adams: Remote monitoring, collaboration and operations are here to stay, with 83% of sponsors and CROs saying most or all of their monitoring will be done remotely in the next three years. The transformation was inevitable, but COVID accelerated it, as 76% of those polled in this year’s study said most of their monitor visits are remote, down from just 18% last year. The way sponsors and CROs change budget allocations also reflects this, with 36% of sponsors reporting an increase in their tech budget in response to COVID. In short, from a distance site access will now be an essential component of clinical operations. CP: What do you plan for future investments in clinical technology? BA: Three main themes emerge: We will see a stronger alignment between the sponsors / CRO and the study sites with regard to their technology needs, with a focus on solving site challenges first to solve the remote access challenges of sponsors. · Study sites will build site technology infrastructure globally to create cohesive processes, enable automation / artificial intelligence, and apply advanced business intelligence capabilities to identify bottlenecks and streamline operations. Remote site access will become critical for clinical trial operations, so sponsors will require their CRO to remotely site access technology and alternative CROs with advanced remote control site access technology will win more requests for proposals from sponsors. I will also add “vaccine in a year” will now be a standard for future viruses and pandemics. Organizations that have the infrastructure to meet these deadlines will be able to meet accelerated deadlines. CP: What type of clinical trial software was used to support Pfizer’s global COVID-19 vaccine study. What does this software involve? BA: We equipped Pfizer’s COVID-19 study with a remote control site access via Florence eHub connected to Florence eBinders eISF during their study sites. Through the Florence eHub, each study site received its own Florence eBinders platform, the electronic file of site industry standard investigators (eISF) to manage its internal research operations. Pfizer then has remote access to regulatory and source files for monitoring. This degree of remote connectivity was achieved by connecting to our network of 8,500 studies sites already on the Florence platform in addition to our implementation team setting up a new study sites who were not yet connected to the Florence platform in as little as a day. On the software, solution sites manage their regulatory documents from creation to submission, including compliant electronic signatures, task management, …
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