Jill Heinz is the Director of Clinical Research for Family Care Research and Injury Care Research. She is joining Agatha’s GM for North American Operations, Ken Lownie, for the webinar Bringing ClinOps Technology to the Clinical Site: Stories from the Frontlines to discuss the opportunities that clinical operations technology, including eTMF, eRegulatory, eQuality, and Remote Monitoring, bring to Clinical Sites.

As a preview to that webinar (which is going to be great!), we thought we’d ask Heinz a few questions about her background and work running clinical sites.

Tell us why you got started in clinical research?

I kind of fell into it actually. I had planned on being a doctor since I was seven. When I was halfway through my undergraduate degree, however, my brother was in a serious car accident and it caused me to come home from college for a year to help with his care.

Honestly, I saw the hours doctors kept and then the multitude of procedures, therapies, and “latest research” that the doctors and therapists spoke with us about and realized being a doctor wasn’t the part I was interested in. I finished up my biology and chemistry degree and then started working at a local oncology hospital where I worked in their research department. It was the beginning of my research career and, 20 years later I haven’t looked back.

What are some of the most interesting/rewarding clinical trials you’ve been involved with?

I’ve found them all interesting. I’ve always been the classic “nerd” who loved studying and learning new things. That’s what is so exciting about research, it’s constant learning.  Not only are we studying and learning about new diseases, treatments, and procedures, as a business owner, I’m also learning about financial statements, strategic planning, and operational efficiency.

It never gets boring. I think everyone working with patients in clinical research has stories of how one of the studies really changed or affected someone’s life. Those are the moments that make all the paperwork worthwhile.

In your work in clinical research, what have you seen as some of the biggest challenges sponsors and CROs face? 

I believe efficiency is their greatest hurdle. There seems to be so much redundancy and waste when you’re looking at it from a site’s perspective. Whether that is in the cost of lab shipping boxes (many of which are shipped in extreme excess) to training programs that site personnel have taken multiple times, often in the same year. I understand it. The cost of NOT being prepared with shipping boxes is likely more than just shipping extra boxes that go to waste.

The mandate to ensure all sites have proper and consistent training justifies asking site personnel who work on multiple studies in a year to take the same eCRF training multiple times in that same year. It just seems to me that so much cost and TIME are wasted in this redundancy. I see Sponsors, CROs, and our industry as a whole trying to change this and become more efficient but, after 20 years in the industry, I also see it as a very slow process.

Sponsor’s run a number of pilot programs to test new strategies and tactics and whitepapers are written about these efforts but, from a site’s point of view, they are rarely implemented at a larger scale and/or on pivotal studies. They’re under a lot of pressure to ensure their drugs and devices get to market so it’s understandable that they stick with the “tried and true” but it also makes sense to consolidate processes and streamline to get those drugs and devices to market faster.

Check out more from Jill Heinz and other clinical operations experts. Read: HOW TO ASSURE CLINICAL QUALITY DURING AND POST-COVID: EXPERT PANEL SUMMARY.

What made you decide to start your own clinical research company?

I was working for a Site Management Organization (SMO) at the time and, while they did great research they did lousy business. Cashflow was always an issue with them. I can actually thank my ex-husband for supporting me and pushing me into starting my own company. He figured I already knew research and, because of that nerdiness I spoke to earlier, I could learn the rest.

Looking back it was kind of crazy. I had a 2-year-old and a newborn when I started my company and everyone knows that sleep eludes both new parents and new entrepreneurs so those early days are a huge blur. I think the allure of starting something of my own was there so I could also control my schedule with two young kids. When you own the company you may work more hours but you also control when those hours are worked and that was attractive to me.  

Technology gives you freedom. I started in this career 20 years ago when none of the CRCs had computers. We had paper calendars, paper source, paper regulatory binders, and CRFs that were carbon copies that the CRAs would Fedex to the Sponsor for data entry. We were tied to that paper. We were tied to our offices. And, while I romanticize how great it would be to go back to the 9-5 and then “shut it off” after work, that really wasn’t the case. I remember on many occasions having to finish charting late into the evenings or having to go into the office on a weekend to report an SAE.

We’re a fully electronic site and have been for a number of years now. I can just as easily report an SAE from my home as I can from the office. A CRC finishes charting for the day after he/she has tucked her kids in for the evening. Technology has allowed me and my staff the flexibility to work where we want and in a manner that fits our lifestyles best. So, with that, my three recommendations would be as follows:

I know implementing technology is scary. It’s new. It’s outside of “how you’ve always done it”. Comfort zones are crossed. I get it, I do. The end result, however, is more than worth the headache of the transition. Certainly in the time of a global pandemic eSource and eRegulatory have made my site more marketable as Sponsors have access to our data in real-time – even before we enter them into the eCRFs. It, however, was useful long before that in the efficiency it gave us in conducting study visits, invoicing, and recruitment of patients. That long-term efficiency is worth the short-term headaches.

Create a plan but don’t get stuck in it.

I jumped into technology and learned to swim later. I wouldn’t advise that. I also wouldn’t advise getting stuck in “analysis paralysis” either. Do your research, ask for referrals, and map out what works best for your company. Maybe it’s to go all in and go with a vendor that provides eSource, eRegulatory, CTMS, etc. all at once, or maybe it makes sense to phase those technologies in one at a time. There’s no perfect answer that works for every company. Pick what works best for your company and then just do it.

Good technology is worth the cost.

Don’t invest in technology that actually causes more steps in your processes. It’s supposed to make your life easier, not harder. When you’re first transitioning to a new technology everything is going to seem more time-consuming and complicated. That’s because it’s new (see recommendation #1). If the vendor trying to sell you on technology or the other users that you speak to as a referral can’t convince you that the cost you’re spending is made up for in the time or money saved then you need to move on to the next vendor.

Good technology should pay for itself in increased operational efficiency. I’ve invested in some software that has made our lives easier and more efficient. It’s allowed my staff and me to accomplish more in less time and at times that work for us. Never once have I felt that technology wasn’t worth the price. That’s good technology and make sure you’re investing in that.

Ready to Learn More From Jill?

Wondering what you’ll learn if you attend the webinar? Here’s the list:

  • An understanding of how ClinOps software fits into the world of the clinical site
  • An example of how one clinical site manager brought in a full range of software solutions successfully
  • A list of the challenges she faced and the strategies she used to overcome them
  • A perspective on the state of the software systems and solutions available today

The webinar will be recorded, so if you can’t join live, register anyway to watch it on demand.

Register for the webinar here.

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