Kristin Brooks, Contract Pharma01.26.21
Florence Healthcare recently released its annual State of Clinical Trial Technology Industry Report. The study of more than 230 clinical operations professionals confirmed what the industry has been seeing over the past 10 months – COVID has forced organizations to accelerate their technology transformation plans, and investment in tech will only accelerate over the next three years.
Florence Healthcare, a platform for electronic document and data workflow management and remote connectivity in clinical trials, is the remote clinical trial software actively supporting Pfizer’s global COVID-19 vaccine study.
Blake Adams, vice president of marketing at Florence Healthcare discusses some of the key findings from the report, 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 key findings from the State of Clinical Trial Technology Industry Report?
Blake Adams: Remote monitoring, collaboration, and operations are here to stay, with 83% of sponsors & 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 respondents in this year's study reported that most of their monitor visits are remote compared to only 18% last year. The way sponsors and CROs are shifting budget allocations also reflect this with 36% of sponsors reporting an increase in their technology budget in response to COVID. In short, remote site access will now be a critical component of clinical operations.
CP: What do you anticipate with respect to future investment in clinical technology?
BA: Three big themes are emerging:
· We will see stronger alignment between sponsors/CROs and study sites with respect to their needs for technology, with a focus on solving site challenges first to solve sponsor remote access challenges.
· Study sites will build out site-wide technology infrastructure to create consistent processes, enable automation/AI, and layer on advanced business intelligence capabilities to identify bottlenecks and streamline operations.
· Remote site access will become critical to clinical trial operations, so sponsors will demand their CRO has remote site access technology, and in-turn CROs with advanced remote site access technology will win more sponsor RFPs.
I'll also add "vaccine within a year" will now be a standard for future viruses and pandemics. Organizations that have the infrastructure to support these timelines will be able to deliver on accelerated timelines.
CP: What type of clinical trial software was used to support Pfizer’s global COVID-19 vaccine study. What does this software entail?
BA: We equipped Pfizer's COVID-19 study with remote site access via Florence eHub connected to Florence eBinders eISF at their study sites. Through the Florence eHub, each study site was given its own Florence eBinders platform, the industry-standard Electronic Investigator Site File (eISF) to manage its internal study 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 study sites already on the Florence platform in addition to our implementation team setting up new study sites that weren't 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 eSignatures, task management, dashboards, and reports. The site also syncs source data securely into the system from any EMR, source platform or paper source. The sponsor and CRA review documents, assign tasks, sync documents with the eTMF, and manage study progress on the platform.
CP: Were there regulatory/compliance hurdles to overcome?
BA: The FDA, and other regulatory organizations, introduced a lot of guidance during COVID-19 to help mitigate some of the disruptions associated with restricted access to study sites. We expect those agencies to begin digging deep into some of the technologies that were introduced during this time period for compliance ramifications. We focus our efforts on international compliance and data privacy and protection, not only with regulatory agencies, but also with privacy laws like GDPR and CCPA. It's important clinical operations leaders evaluate band-aid solutions they put in place during COVID against these standards.
Blake Adams leads marketing and growth for Florence, the leading remote site access and eISF platform in clinical research. Blake has spent over 6 years in executive leadership roles in healthcare technology, the last four of which helping build Florence. Prior to Florence Blake served in marketing leadership for Payspan, a Fintech company in healthcare, and Good Samaritan Health Centers, in addition to several years in international NGO consulting roles and other marketing functions. Blake loves talking about tech innovation in healthcare.
Florence Healthcare, a platform for electronic document and data workflow management and remote connectivity in clinical trials, is the remote clinical trial software actively supporting Pfizer’s global COVID-19 vaccine study.
Blake Adams, vice president of marketing at Florence Healthcare discusses some of the key findings from the report, 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 key findings from the State of Clinical Trial Technology Industry Report?
Blake Adams: Remote monitoring, collaboration, and operations are here to stay, with 83% of sponsors & 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 respondents in this year's study reported that most of their monitor visits are remote compared to only 18% last year. The way sponsors and CROs are shifting budget allocations also reflect this with 36% of sponsors reporting an increase in their technology budget in response to COVID. In short, remote site access will now be a critical component of clinical operations.
CP: What do you anticipate with respect to future investment in clinical technology?
BA: Three big themes are emerging:
· We will see stronger alignment between sponsors/CROs and study sites with respect to their needs for technology, with a focus on solving site challenges first to solve sponsor remote access challenges.
· Study sites will build out site-wide technology infrastructure to create consistent processes, enable automation/AI, and layer on advanced business intelligence capabilities to identify bottlenecks and streamline operations.
· Remote site access will become critical to clinical trial operations, so sponsors will demand their CRO has remote site access technology, and in-turn CROs with advanced remote site access technology will win more sponsor RFPs.
I'll also add "vaccine within a year" will now be a standard for future viruses and pandemics. Organizations that have the infrastructure to support these timelines will be able to deliver on accelerated timelines.
CP: What type of clinical trial software was used to support Pfizer’s global COVID-19 vaccine study. What does this software entail?
BA: We equipped Pfizer's COVID-19 study with remote site access via Florence eHub connected to Florence eBinders eISF at their study sites. Through the Florence eHub, each study site was given its own Florence eBinders platform, the industry-standard Electronic Investigator Site File (eISF) to manage its internal study 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 study sites already on the Florence platform in addition to our implementation team setting up new study sites that weren't 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 eSignatures, task management, dashboards, and reports. The site also syncs source data securely into the system from any EMR, source platform or paper source. The sponsor and CRA review documents, assign tasks, sync documents with the eTMF, and manage study progress on the platform.
CP: Were there regulatory/compliance hurdles to overcome?
BA: The FDA, and other regulatory organizations, introduced a lot of guidance during COVID-19 to help mitigate some of the disruptions associated with restricted access to study sites. We expect those agencies to begin digging deep into some of the technologies that were introduced during this time period for compliance ramifications. We focus our efforts on international compliance and data privacy and protection, not only with regulatory agencies, but also with privacy laws like GDPR and CCPA. It's important clinical operations leaders evaluate band-aid solutions they put in place during COVID against these standards.
