Go beyond paper-based workflows for medical device trials


Around March 2020, the sponsors were in trouble: THey had to quickly adopt electronic patient-reported results (epOR), electronic informed consent (Electronic consent) and other decentralized technologies as medical device trials — and the world, really — have gone virtual.

To date, this well-intentioned sprint has created a hodgepodge of disparate solutions. This new issue comes on top of the fact that many eClinical solutions are designed for more robust pharmaceutical trials and include unnecessary features that add complexity and confusion for sites engaged in medical device protocols.

Taken together, these trends are forcing many understaffed and burnt-out sites to go back to what they know: paper logs, which can ultimately drive up costs due to duplicate workflows and missing data. The problem is not so much the technology as its imbalance. Most clinical trial solutions are not the right size for medical device testing.

“Many sites are expressing frustration with the difficulty of managing the different data sources that come with not integrating technology, and we’ve certainly seen a lot more of that fragmentation in the move toward decentralized trials,” Tina said. . Caruana, eClinical Solutions Subject Matter Expert at Medrio. “What’s happening is that it’s preventing sites from doing what they need to do, like caring for their patients, recruiting subjects into trials and retaining them – which is what the technology is supposed to help first. venue.”

Disparate solutions create additional validation and connection steps, which complicates workflows and creates unnecessary data. But when sponsors don’t optimize for the right platforms, it can also delay data collection. Both can delay trials at a time when competition has never been so ruthless and the need for speed in medical device testing has never been greater.

As they address these challenges, sponsors will need to rethink their technology landscape and adopt more suitable solutions that will actually be used and preferred, over paper. We asked Caruana for his thoughts on what to do.

1. Assess

Audit your technology landscape to identify what’s needed and what isn’t, Caruana suggested. Such an audit can help sponsors determine which combination of solutions, such as eConsent, ePRO, and trial supply randomization and management, would be right for their trial.. After all, when you use only the necessary features, it can support data integrity and speed up trials for faster market entry.

“You don’t want to throw everything against the wall all at once,” Caruana said. “The best partners are deliberate and aware of what is required for the study.”

Strike the right balance of solutions with a trial-specific approach, she added. Depending on many factors, the digital ecosystem of each protocol may vary from protocol to protocol.

“It depends on the protocol,” Caruana noted. “How many subjects? Who are the subjects? What are their ages? What is the therapeutic area? All of this has an impact on what solutions you use and don’t use.

2. Integrate

Once a sponsor understands its technology landscape, the next goal is integration – in other words, applying compatible technologies that communicate with each other through more meaningful technology partnerships.

Over the past few years, vendors have used APIs as a foray into integration, especially as a technology company Mergers and Acquisitions led to the need to assemble a hodgepodge of solutions. But Caruana warned against overreliance on APIscalling them costly and potential sources of performance issues.

“You want to look for a fully, natively integrated system from the same vendor,” Caruana said. “Priorize vendors that operate from a single code base for all tools – whether it’s eConsent, ePRO, electronic data capture or others solutions.”

By consolidating vendor contracts, you in turn consolidate technologies for a complementary and aligned experience. Sites only need to learn one system, reducing trial management complexity for all protocols, but especially for decentralized protocols that connect sites to their dispersed patients and CROs.

Other benefits of this model include the freedom to switch between different solutions for different trials and the fact that it consolidates all data in one safe place to streamline workflows, reduce inconsistencies, alleviate frustrations and minimize manual elevation of sites.

3. Simplify

Integration makes things easier for users, but there are also other possibilities for simplification.

Consider the interface. Solutions with pre-built but flexible Dashboards – enabled by drag-and-drop tools with no coding needed – help sponsors get started faster to go live faster, without depending on an outside company or specialized personnel to build their unique study workflows.

Other features, such as single sign-on, are equally essential for streamlining site and topic experiences. Ultimately, opt for solutions designed to allow users to do what they need to do, whether it’s entering log information, filling out a licensed form, or other tasks.

“You want something intuitive and consistent in navigating and accessing from tool to tool,” Caruana said. “Nobody wants to relearn software every time you add a new solution to your technology ecosystem.”

4. Learn

Salespeople absolutely must have the expertise to “do it all” for you, if that’s what you want. But there is also merit in autonomy. Build relationships with partners who can help you learn to function independently through a blend of guided autonomy.

That means looking for those that offer training, professional services, pre-built workflows, and other help tools. Continuity of support ensures the continuity of the partnership from initial construction through study closure as your needs and capabilities change.

“I like to think of it as a crawl-walk-run metaphor,” Caruana said. “Your first study, you may need a little more help in terms of training resources – just to learn the ropes. As you gain experience, you are better off. able to walk and build a lot of the infrastructure in-house, ultimately you can build on that foundation and start operating on your own, if that’s what you want to do.

True to size, but don’t revolutionize

Growing eClinical technology management has complicated workflows and frustrated sites. Now is the time to re-evaluate this mix for smarter platforms that work harder for each protocol. But remember — the best technology imitates and improves on paper.

Take the good but not the bad of traditional workflows, leveraging technology to scale, but not revolutionize, your data collection engine. When you do, you might be surprised at how easy things can be.

See more Caruana ideas for medical device sponsors in Medrio’s whitepaper, Get your medical device trials to market faster. »


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