Sponsors and CROs have invested millions of dollars or more in automating clinical operations since the 90s. And every study they do is includes one or more clinical sites where patients are treated, and data originates. Yet, clinical sites trail behind in terms of Clinical operations technology (clinops) adoption.

In a recent webinar, Agatha’s head of North American Operations, Ken Lownie, talked with Jill Heinz, the President and Director of Clinical Research for Family Care Research and Injury Care Research, to understand why sites are struggling with clinops technology, and how she brought automation to her sites early on.

Ken talked about three critical drivers to clinical operations technology adoption:

  1. Clinical sites are expensive, which is why there is a lot of technology built that focuses on this industry.
  2. It’s commonly understood that IT projects often fail (i.e., they are not completed on time or with expected functionality). Part of the challenge to software implementations is the approach – agile vs. waterfall. Traditionally, the waterfall method has been employed with IT projects, meaning the entire implementation is done at once (think “big bang”). When you look at the causes of failure, the most common ones are not related to technology but behavioral and organizational challenges.
  3. Sites carry the highest-burden – they have more paperwork, need more staff, and spend more money to complete a trial.

Sites are a missing piece of the puzzle, according to Ken, essential to getting the best value out of automation for all parties involved. But sites are typically under-funded and often small. If they are in large hospitals, sites deal with a bureaucracy that makes automation challenging to adopt.

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“Clinical sites often find themselves as the tail of the dog being wagged. They end up with a burden to do more paperwork, take more staff time, invest more money, and complete the clinical study designed by a sponsor and CRO. And site burden is a really good term because it creates the image of the site carrying a lot of the load, but without similar budgets and tools.”

Ken Lownie

“Under automation at the site affects the whole ecosystem; you lose the flow from the site to the CRO, to the sponsor, and back to the site. You get interrupted if the site isn’t automated, and everything goes back to paper, copying, should I say faxing, different ways of communicating information that affects the whole system trying to improve automation. I know Jill, and I have talked about this. It’ll probably come up again, that everything goes back to paper at the site if the site’s not automated.”

Jill’s sites are fully automated. She shared the path she took to implementing clinical operations technology and what she learned in the process.

Clinical Operations Technology

Clinical Sites can use many different types of technology. There are three to four that are most common, and the ones Jill implemented first in her company.

She talked about starting her first company ten years ago and everything was paper when she started in clinical research. When her first business was getting off the ground, CTMS software was beginning to be a standard application for sites. So she adopted the technology. A few years later, she adopted eRegulatory software.

“We have a lot of storage that needs to happen. And when regulatory binders take up six, two-inch binders, that takes up a lot of shelf space. They’re not searchable. You lose the memos and the correspondence that you want to be able to search through. It’s just cumbersome. And inevitably, those binders break – it’s just messy.“

After eRegulatory, Jill’s companies adopted eSource software. When it came time to look for eConsent software, she had learned a lot about the decision process. She said that it’s essential to look at multiple vendors in terms of price and features. Most importantly, she said before you implement a solution, you need to define your processes, such as who will manage the solution? Who will use it? What templates do they need to add, etc.? You need to have an implementation plan and not merely dive in and start using the system without understanding how to use it properly.

For the last three and a half years, her companies have been fully automated. Knowing what she knows now, Ken asked Jill if she would follow a best of breed approach to software adoption or look for a “suite” or “all-in-one vendor?”

Jill said that when they selected their eSource vendor, it only offered eSource. Then that vendor added other aspects, like financial (CTMS), regulatory, recruitment, others. As the vendor added new solutions, her companies switched to those solutions.

Jill’s Advice for Clinical Sites

Jill speaks to many site directors and site owners looking for her advice because they know her companies are fully automated. She always gives the background of how she got where she is today and tells them it’s important to do what works for their site (every site operates differently).

“I went with the total solution vendor because anybody that works at the site level knows we have about a thousand different vendors and modules we have to log into at any given time. I didn’t want that fragmentation at my site. My entire staff logs into a single place –  from invoicing to recruitment to everything in between logs every day. And they all talk to each other.”

She also talked about working across sponsors and CROs, each with different systems. She said she couldn’t control what sponsors require; her coordinators deal with different eCRF modules, different patient-record outcome software, and even sponsors who want documents zipped and emailed.

“It’s a broad system that my coordinators have to figure out, and why it was so attractive for me to keep the stuff at the site as simple and cohesive as possible because we’re spread out across many, many different systems as far as what the sponsors give us.”

Jill Heinz

There are other benefits to being fully automated.

“Being fully electronic has been so beneficial during this current pandemic. Our workflow really hasn’t changed. We did that before the pandemic. Our system is such that we can give access to whoever needs to have access to only the study that the person is allotted to.

With these various programs that we’re starting to see, you can give access to the study monitor for that particular study. And then that study monitor has—it’s almost like he or she is sitting at your site, going through the paper binder. They can see everything in that binder.”

And then there’s COVID and the increased push for remote monitoring:

“Prior to COVID, we had a little bit of resistance from study sponsors, from CROs, at some of the technology. It’s new, and it’s different, so, therefore, it’s a little scary. Post-COVID, and—well, not post. I wish we were post-COVID. But during COVID, you’re right, Ken, it’s been an incredibly attractive scenario. When study sponsors find out they can fully remotely monitor us with little to no change in how we conduct our business, it’s been a big selling point for new studies these last seven, eight months.”

Key Takeaways

There are a few key takeaways from Jill and Ken’s discussion on software adoption in clinical sites. First, it’s beneficial for sites to automated their systems, especially now. Sponsors and CROs can quickly get access to the information they need to ensure studies are appropriately conducted.

It’s also less work for sites in the end. Yes, there is a cost to automation, but you will find the technology pays for itself in terms of recaptured time and money over time.

Another important consideration when you do decide to purchase your software solutions – don’t select your vendor on features and price alone. Look for a vendor (s) who will help you through the software planning and implementation process – like a trusted partner committed to your success.

There’s a lot more in the webinar than covered here. You can watch the entire replay on-demand. And if you’d like to chat with Ken about the work he’s doing, let us know. He is always interested in helping clinical sponsors, CROs, and sites find success in their software implementations.

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