But even as the opportunity for CROs grows, many are left questioning whether trials can be conducted with the same methods and economics as before COVID.
A recent study with over 40 CROs about technology plans for remote site access during the COVID-19 outbreak found that remote feasibility, study startup, patient consent, data collection and remote monitoring are key elements that must be considered. Specifically, CRO executives wanted to know:
• What are my options for remote site access, and will I still need it in the long term as sites reopen?
• If I introduce a remote site access technology, will sites accept it?
• What will be the economic impact if I permanently move to a remote site strategy?
What are my options for remote site access, and will I still need it in the long term as sites reopen?
Though many CROs hope to resume regular site access as they work through a backlog of studies designed, pre-COVID, around old site access approaches; hope, it is said, is not a good strategy.
CROs instead must build a portfolio of remote access solutions to have at the ready as both a primary strategy and an insurance policy for older monitoring designs. Progressive CROs and sponsors will launch with a wholly remote site access strategy. More conservative CROs and sponsors must have the same approaches available as an insurance policy if site access and travel doesn’t return in the way they expect.
Some CROS believe it is advantageous to assemble a four-part package for remote site monitoring to meet these needs:
1. Remote feasibility and SIV
2. Remote patient data collection like eSource and eConsent modules
3. Dedicated remote startup and monitoring tools
4. Remote site access and remote monitoring through software that lives at and is controlled by the site
With these tools in place, site management can be wholly remote—from site initiation through medication and supply management. Notably, the package is modular and assembled from best of breed tools, not a rigid, one size fits all platform. A modular approach allows CROs to be agile in the face of changing conditions, or gradually migrate old site management approaches toward virtual piece by piece.
If I introduce a remote site access technology, will sites accept it?
Baseline requirements for trial technologies are different in today’s COVID environment. Integration and feature volume characterized the right solution choices in 2019. But today, because so much work is virtual, ease of use wins. Ease of use is the lead requirement both for sites, to ensure acceptance, and also for CRAs, to ensure productivity. If CROs provide easy to use tools, sites will accept them. In a recent COVID study done by Florence Healthcare, 94% of sites adopted remote trial monitoring software. In another group of studies, over 1,300 CRAs were onboarded to a virtual monitoring platform in a month’s time.
What will be the long-term economic impact of remote site access on my CRO?
First of all, overall research activity is up, which is positive for the industry overall. Navigating change is easier when business is good.
Second, while CROs must change their methods of site interaction, the economics need not change. In fact, many CROs in the industry have made two changes to their monitoring business in the past few months, and the news is good:
1. Site monitoring plans, from a billable-hours perspective, can be held stable. Given increased uncertainty in enrollment, site availability and access, the need for good monitoring is as strong as ever—even if it is remote.
2. Pass-through expenses for travel will shrink, to be replaced in part by increased technology costs. In other words, the need for risk management through high quality monitoring is the same, the expected overall costs can be the same, but the methods have changed.
Summing it up
Overall, virtual or remote site access is impacting the CRO business as follows:
• CROs must offer a portfolio of remote access tools to their clients
• Ease of use is the primary criteria for selecting these tools
• Long term, CRO economics needn’t change, but travel will be reduced, technology investment will grow and speed can increase
• It’s imperative to find the right technology partner to support your CRO’s portfolio approach to remote site access and ensure success in a new digital landscape necessitated by COVID-19
Ryan Jones is the CEO of leading clinical trial software company Florence Healthcare. Florence advances clinical research through software – its electronic Investigator Site File (eISF) helps over 7,000 research teams around the world take their day back from paper. Before joining Florence, Ryan was president of Pubget, a research platform serving clinicians at over 600 hospitals and research institutions worldwide.