Catherine-Gregor, Florence Healthcare

Q&A with Florence Healthcare’s Catherine Gregor

By Andrew Humphreys • [email protected]

Med Ad News talked to Florence Healthcare Chief Clinical Trial Officer Catherine Gregor regarding the state of clinical trial site enablement technology in 2023.

Med Ad News: How has the approach by research sites and sponsors to rely on technology for their clinical trials changed since the start of the COVID-19 pandemic?

Catherine Gregor: Remote connectivity became increasingly important in 2020, 2021, and 2022 as the clinical research industry reacted to changes in site access and the move to work from home. Work that was traditionally done on-site and in-person prior to the pandemic had to be reimagined in order to keep patients on study and keep data moving. This change forced sponsors and sites to collaborate electronically to maintain data quality and study oversight.

Accordingly, remote monitoring has ranked as the top problem sponsors and sites are working to solve for the last two years (with 28 percent ranking it as #1 in 2021 and 29 percent ranking it as #1 in 2022). This trend is expected to continue into 2023, despite the relaxation of pandemic measures, as sites and sponsors have realized the longer-term value of remote access.

Med Ad News: Please explain the process behind and the benefits of site enablement technology.

Gregor: Site enablement technologies are systems that better accommodate site workflows by helping them create and exchange data with sponsors in real time and with less effort. Site enablement technologies like eISF, eSource, eConsent, and ePRO should eliminate mundane and repetitive busywork for sites – like entering data into multiple portals or copying documents – by allowing sites to seamlessly transfer documents and data from their systems into sponsor systems.

Med Ad News: What trends are emerging among research sites and sponsors based on Florence Healthcare’s annual survey results?

Gregor: In addition to an emphasis on site enablement, 2023 will bring heavy emphasis on site-sponsor collaboration and site adoption. Sites say their number-one technology concern is whether sponsors will accept their technology, and 65 percent of sponsors say they’re concerned about whether sites see them as a “sponsor of choice.”

If sponsors want to win the trust of sites, they must collaborate with sites on what technology will work for both of them. This can also help with site adoption of new technology, which is a concern for 42 percent of sponsors. Sites’ voices matter in 2023, perhaps more than ever before.

Med Ad News: What are some key recommendations for sponsors and CROs to optimize the effectiveness of their site technology investments in 2023?

Gregor: Sites and sponsors are in desperate need of technology that links them to one another and facilitates collaboration rather than fragmented data flow. Data flow from participants to the site to the sponsor will become more seamless as sites and sponsors begin to look for software with open APIs (software that can integrate, even if it’s from different vendors).

Sites are also getting louder in their assertion that sites should have the ability to establish and maintain their own study workflows instead of being forced into predefined ones. This flexibility allows sites to spend less time managing study data and more time managing patient care, which is where the true value is for all of us.

Additionally, redundant data entry opens opportunities for transcription errors, which can generate an increased number of data queries for the site and sponsor to manage. This slows down data lock and adds to the overall problem of protracted timelines for sponsors and sites.

Med Ad News: What are some recommendations for research sites to optimize the impact of their technology investments and sponsor collaborations during 2023?

Gregor: We know clinical trials are only growing more complex and diversity initiatives are pushing sites and sponsors to focus on increasing patient access, at the same time that staff turnover rates are at their highest. So to expand patient access, equip more sites to participate in research, and maintain compliance and oversight, we are seeing a massive influx of new technology vendors. Unfortunately, these vendors often design their solutions to meet the needs of only one side of the value chain: sponsor or site. This design failure results in a disconnected ecosystem of hard-to-use solutions.

To solve these challenges, sites should prioritize integrations and ease-of-use across stakeholder groups. Because sites will have many studies, technology solutions have to be site-specific instead of study-specific to maximize value. We have to give sites options so that they can choose what technology works best for them and their patient populations, which means technology that can be easily adopted with minimal interruptions to workflows. Sites also need technology that allows sponsors and CROs to remotely access existing site data (i.e. eISF, CTMS, and eSource/EHR).

Andrew Humphreys is contributing editor of Med Ad News and