Author: ClinEdge Staff

A Q&A With MediSync Clinical Research

Recently, the Elligo team interviewed Jeff Repper, Vice President, and Claire Dean, Business Development Associate, from MediSync Clinical Research. MediSync is a leading site partner directly involved in conducting COVID-19 vaccine trials and understands firsthand how to break into them. Read more to learn about their business development strategy, managing enrollment logistics, and overcoming operational and administrative challenges.

What business development strategy did your team execute on in pursuit of conducting a COVID-19 vaccine study?

MediSync Clinical Research is a small network of sites with five sites across the country – in Texas, Mississippi, and Ohio, and our standard approach for business development is to ensure our pipeline is both robust and diverse. The diversity comes in two forms – one is in the therapeutic area and the other is with different sponsors, different CRO’s, and different people that we work with. This was a good and helpful starting point for us, that we had contacts at a lot of different companies.

My advice is to look at your own rolodex, see who you know, and reach out early. We reached out to a lot of people, many that we didn’t even know just to see if they were going to have a COVID-19 vaccine coming up. We wanted to touch base with them and just say ‘Hey, how are you? Remember us?’ and ‘if this does happen we would love to be a part of it.’ From there, we kept a close eye on press releases, once a press release hit saying that there were positive early phase results with plans to start another phase, we would come back to that person and re-engage. If you do not re-engage there is a good chance they will forget about you, and the fact that you were interested. When you do plan to re-engage make sure to be thoughtful with what you include, if you have metrics or data about your site, numbers on patient population, incidence rate, or any other important information make sure to include that as it is a valuable resource for them to have, and will be a large factor in how they choose their sites. But more importantly, it is very easy for that information to be sent up the chain of command, that data is going to speak for itself when the right person looks at it.

Something new and different that MediSync did, is we got an interest rate from our patient population. We chose one or two hundred patients from our groups and sent out pilot outreach to get a feel for if they would be interested in a COVID-19 vaccine trial if we were to get one. With this information, we would be able to go to a sponsor and say 60-70% of people that we talked to about this trial are interested with about 80 people on a waitlist that are ready to go if we were to contact them. This is showing the sponsor that we are already putting the work in, and that we are going to continue to put the work in with the ability to move things along at a fast pace.

Once you receive an answer from a sponsor, whether it is yes, we want you to be our site, or no, you’re not a good fit for us, whatever the answer may be, it is never necessarily a final answer. It is possible for a site to lose studies after receiving a yes, to avoid this, you want to make sure you are staying engaged, continuing to understand what the sponsors expectations are, staying prepared to meet the ever changing expectations, but above all, communicating it back to your sponsor. You may know that you are well equipped to meet changing expectations, but if you do not inform the sponsor they are not going to know, which may result in being dropped from the study.

More importantly, if you do receive a ‘no’, it is not necessarily the final answer. MediSync has been told no quite a few times, and the way I look at it is there are two types of No’s, and it comes down to a matter of which can be changed. First, find out why they said no, if it is due to something that can be changed, make a plan and communicate it back to the sponsor – equipment, staffing, recruitment plan, enrollment expectations, etc. If the reason is that what you are doing now isn’t enough for them, make an internal plan, communicate it back to them, and explain how it will benefit them. This method has worked for us in the past, and for the sponsor to agree and end up taking us on as a site. The second form of no is something that cannot necessarily be changed, which can be a little bit trickier. If it is something like the size of the population or the incidence rate, is it possible for you to change their perspective on it? For example, if your patient size is rather small, but you have a really engaged PI or strong community ties, and you’re able to engage that smaller population well, remind them of that. A site with a huge patient population that cannot engage them is not as good as a smaller site with great engagement rates that can secure the patients while also having a great retention rate.

Personally, one of our sites in Austin, TX, had an incidence rate that in general was shown to be going down, and the sponsor told us no due to this reason, so MediSync dug deeper into the data only to realize we were actually in a bubble of higher incidence rate within the city, we shared this with the sponsor who recognized that our data was correct. It is important to continue to share graphs and show the trend lines, and prove that your site is going to be able to get the cases needed. Overall, be timely, be thoughtful with your outreach, and know that answer isn’t always the final answer.”

— Claire Dean, Business Development Associate, MediSync Clinical Research

What business development strategy did your team execute on in pursuit of conducting a COVID-19 vaccine study?

All of our research sites are dedicated, the exam rooms, storage space, everything is all dedicated 100% to clinical research, and while we have vaccine and high-volume experience, nothing compares to this.

The first step we took was in March we started to reach out to our colleagues in the industry, and when the opportunity arose for qualification visits the initial response was no. We didn’t give up, we pushed back, the expectation was that these studies were going to simultaneously conduct their early and pivotal studies at the same time, and originally the timeline was June, so we ended up having to lay off the majority of our staff because our productivity went from being able to support all of our site levels to being down over 90% within the first two weeks of the pandemic. It was an absolute catastrophic meltdown. After the initial ‘no’ we went back at the end of May with more data, we ended up getting a yes with a start date of June. We had to scramble and get everybody back.

The communication between MediSync and the sponsor became very ‘we will help you with the stuff that you need’ because prior to the pandemic we did not have requirements for PPE in the ways that we do now with N95s, full gowns, face shields, etc. We weren’t sure where to source those items, and we knew that if anything, this was going to go fast. The study team had expected to have 30 clinical trial sites with 6,000 patients enrolled and they expected it within a week. We knew that in order to fill our obligation to the study team that we would have to be full staffed, work on the weekend, and have everything on board and ready. We went about the business of doing this and the study didn’t happen for two months. It is important to understand your obligations are going to be up front. We had the benefit of experience to know what we think would be a reasonable timeline for how long visits are going to last, and those types of things. So we set up our calendar accordingly and we had a moratorium on paid time off. I would characterize it as the Super Bowl, this is our Super Bowl of clinical trials right now, that we have the opportunity to participate in something that could greatly impact how long and how severe this pandemic is and everybody rallied around that. We were able to staff our clients, bring in new additional staff as well as temporary staff. There is a requirement for same day data entry, which is usually uncommon in these types of circumstances, so we brought in vendor personnel to work in an unblinded capacity, and to also work on same day data entry in addition to the staff we had onsite.

We did practice runs with mock patients in an effort to calibrate our data collection tools. We would practice our study visits ahead of time to help confirm our timeline expectation. We would also re-tool our source documents from what we thought we needed to what we actually needed. We didn’t have the opportunity to ease into this with trying it out with a couple of patients to learn from what does or doesn’t work, we had to be ready to hit the ground running.

These studies are different from what we would typically see inside of the industry, by the time one of these studies finished enrollment we were on amendment 10 or 11. If you are not able to adapt to what is going on in the clinical trial then you are not going to be able to reach your enrollment figures, you’re not going to be able to collect and report the data appropriately, and ultimately, not going to be successful in your trial. What I expect is that the success that happens in any of these vaccine programs will bode well for future business development efforts. You have one chance at this, if you don’t do it well, and don’t do it right, that’s it.

— Jeff Repper, Vice President, MediSync Clinical Research

What are the biggest challenges associated with conducting a COVID-19 Vaccine study?

The single biggest challenge from my perspective as an administrator is all the variability and the changes that take place inside the study. For example we had six contract amendments, about 10 or 11 protocol amendments, changes to the clinic schedule – all the things that we would have to put into our CTMS in order to be able to manage this and bill it appropriately.

— Jeff Repper, Vice President, MediSync Clinical Research

Would you do anything differently when conducting a future COVID-19 trial?

From an operational standpoint, if you’ve done vaccine studies, these really aren’t that different. My advice for those that don’t have any vaccine experience is to definitely do the trial runs and get everything you need prepared ahead of time and make sure it works. One thing that I will say is something that we had never done or had experience with from a patient recruitment standpoint is to actually go on the news. I now have a standing interview with NPR in Austin now to give updates on this. This is our 11th year of having clinical trial sites with MediSync and to try and get a press release to stick before was almost impossible.

What we have worked to change now, is that we have an infrastructure on the back end of our patient facing websites to be able to better handle the influx of interest forms and phone calls, this is mostly due to the first time we went on the news in the Austin area our website had crashed as a result of the influx of interest and feedback. It wasn’t something that we were prepared for at that time, so we made changes to the backend so that we would be able to handle more volume and to better capture the information needed from these people that are showing interest.

One of the things that I’m excited to do moving forward is lean into that publicity piece. We work with pharmaceutical companies to develop press releases, and we got the information to them that we could actually present to the media, and the response has been overwhelming. In every one of our markets we have been able to go on the news, highlight what we are doing, and answer any questions. If you do get an award, I would recommend talking to your sponsor or CRO to push for leaning into the media. They may say no at first, but they most likely will do it and the response is tremendous.

— Jeff Repper, Vice President, MediSync Clinical Research

What would be the best advice you could give to a site looking to be selected for a future COVID-19 vaccine study who may not have much (if any) vaccine experience? & What advice would you give that site for successful execution of the trial?

This goes back to a lot of what was mentioned earlier, but to be collaborative with the sponsor. There is often a perceived notion of a power dynamic, where the sponsor is higher than that of a site, but the reality of it, is that this is an ecosystem, the sponsors need the sites as much as the sites need the sponsors. We are in an unprecedented time where everyone is still trying to adapt, that’s why my advice is to collaborate with the sponsor. Be honest with them, tell them what you need, work with them on the media, and on recruitment, get a trailer if you need a trailer. Just make sure to collaborate with them so that everyone is successful. When the sponsor sees you doing this, it sets you apart and they will want to work with you. Let the sponsor know what you need to become the closest to a perfect site you can be, it will go a lot farther than pretending you are already a perfect site that you are not going to live up to.

— Claire Dean, Business Development Associate, MediSync Clinical Research

Do your best to prepare so that when you do get your chance you can make the most of it and it will do well for your business moving forward.

— Jeff Repper, Vice President, MediSync Clinical Research

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