CTNx Operations: The Secret to Running a Successful Research Site

Blog Post banner for an interview with CTNx's Operations team and how they provide support to clinical research sites.

Q: Can you tell us a little bit about CTNx’s Operations Team and your primary objective?

Mikayla: Absolutely. The Operations Team at CTNx serves as the daily support system for our research sites. We are a consistent point of contact that Investigators and Coordinators can rely on throughout the day—whether they have protocol-specific questions, need help navigating study logistics, or simply want a sounding board.

Many sites that have come to us with prior research experience have shared that they often felt isolated and experienced delays when trying to get answers directly from sponsors. With CTNx, every site is paired with a dedicated Operations Specialist who is familiar with the protocol and available to provide timely support.

Sophia: Beyond being responsive, our team also takes on a significant portion of the clerical and administrative work—freeing up our sites to focus on what matters most: patient care and clinical execution. Removing this from the site’s workload allows them to see more patients which translates to higher enrollment, and ultimately increased revenue for their research program.

Q: How do you help sites prepare as they take on a new study?

Mikayla:
We play a hands-on role in helping our sites prepare for new studies, starting with a detailed review of the protocol and regulatory requirements. We walk through everything with them, because truly understanding what’s expected is essential to a successful launch. Our goal is to ensure each site is aligned with the protocol and all relevant guidelines from day one.

Sophia:
We also build out the study framework within our Clinical Trial Management System (CTMS), also known as the eSource. This includes mapping out the sequence of study activities and defining the specific data points that need to be captured at each patient visit.

The eSource presents this information in a clear, digestible format, allowing Coordinators to easily read, understand, and comprehend what’s required. It includes protocol-specified instructions and guidelines to help sites prepare thoroughly and ensure that all procedures are in place and ready to go on the day of the visit.

This structured approach makes it easy for Investigators and Research Coordinators to know exactly what tasks need to be completed and what data must be collected for every visit. Without this level of support, sites would have to map things out on their own — which could lead to confusion, disorganization, and compliance risks.

Q: How do you help avoid compliance risks?

Mikayla: A major part of our role is focused on data oversight. We oversee the entered data and source documentation, ensuring everything remains clean, accurate, and aligned with the protocol within the Clinical Trial Management System (CTMS). Minor mistakes can sometimes slip through when source documents are first submitted to us, but our proactive approach allows us to catch and correct those issues before they become larger compliance problems.

Sophia: Essentially, we serve as the primary link between research sites and Sponsors, and ensure strong data management which is critical to a site’s overall success. By maintaining thorough documentation, we also ensure that sites are audit-ready and can provide clear proof of compliance if they were ever to undergo a Sponsor or FDA audit.

Q: Can you share more about how you help free up your sites’ time?

Mikayla: One of the most valuable ways we support our sites is by handling data transcription. During each visit, the Research Coordinator collects important data from the patient, which needs to be entered into two systems: the Clinical Trial Management Software (CTMS) and the sponsor’s Electronic Data Capture (EDC) system.

When a site partners with CTNx, the Coordinator only needs to enter the data once—into our Clinical Trial Management System (CTMS). From there, our team reviews the data for accuracy and compliance (often catching issues early) and then transcribes it into the sponsor’s EDC. This removes a significant administrative burden from the Coordinator’s workload. In fact, several experienced Coordinators who previously had to enter data into both systems have told us CTNx’s data transcription saves them around 1.5 to 2 days per week. That time savings allows them to focus on patient care—ultimately enabling the site to see more patients and generate more research revenue.

Sophia: Another thing on this front that we help with is query resolution. These are follow-up questions that come from the study monitor about study data that has been entered. Because we manage the data transcription process, the number of queries is often cut in half from the start. And when queries do come through, we’re able to resolve about 60% of them without needing to bother the Coordinator or Principal Investigator.

Q: In your opinion, what makes the most successful research sites?

Mikayla: That’s an easy one—strong communication. Our most successful sites consistently keep us in the loop and are responsive. Sites that struggle with communication often face unnecessary delays and have a much harder time achieving success.

At CTNx, we’re a valuable resource for our Research Coordinators and PIs. We provide answers, guidance, and support so that issues can be resolved quickly—often before they need to be escalated to a monitor or sponsor. We also create a safe space where no question is too small or off-limits. Clear, open communication helps everything run more smoothly.

Sophia: To add to what Mikayla shared, we also hold bi-weekly meetings with our Principal Investigators and Coordinators. These calls are efficient—PIs often only need to join for about 15 minutes—but their participation is important. It ensures everyone stays aligned, engaged, and aware of their responsibilities. We already take a large portion of the workload off their plate, so spending that time with us helps deepen their engagement and ownership of the research process.

During these calls, we address and resolve any open issues, reorder supplies, and prepare for upcoming patient visits. It’s one more way we help keep sites proactive, not reactive—and that makes all the difference.

Q: Mikayla, can you share 1-2 success stories from the sites you support?

Multispecialty Site in CA
When I first started working with one of our sites in California, they were really struggling. Documentation was inconsistent, enrollment was low, and communication with the team was poor. Honestly, we weren’t sure they would succeed with their research program. But I had high hopes and believed I could help turn things around. After going on-site and working closely with the team, we saw major improvements. They started enrolling consistently, communication picked up, and they learned how to properly document data and subject information. Today, they’re the top enroller for a pretty large study — a huge turnaround, and I’m really proud of the progress they’ve made.

GI & Neurology Site in SC
One of our sites in South Carolina was another site facing multiple challenges. They were behind on documentation and enrollment, and the PI was worried about finances. I stepped in, provided additional training, visited on-site, and had a candid conversation with the PI and Coordinator about expectations and what needed to change. As a result, they decided to hire an experienced Research Coordinator, which made an immediate impact. Since then, they’ve been enrolling in both specialties — GI and Neuro — and communication and documentation have improved significantly. They now manage over 12 active studies and are even looking to hire a third Coordinator to keep up with growth. It’s been an amazing transformation.

Q: Sophia, can you please share 1-2 success stories from the sites you support?

Dermatology Site in WY
At one site in Wyoming, we had a temperature excursion that could’ve resulted in the investigational product being unusable. I jumped in and within five days, I got everything back on track — handling the temperature logs, documentation, filling out forms, and completing the sponsor’s reports. Because we caught the issue early, the IP stayed suitable for use. That saved the site more than three days of extra work for the Research Coordinator and prevented the destruction of the product. It also meant no patient visits had to be canceled, and no extra IRB reporting was needed. Catching it early really kept the study running smoothly.”

Gastroenterology Site in OH
We had another site in which the sponsor had flagged over 300 protocol deviations that hadn’t been entered throughout the study. I took responsibility and entered all the deviations across three different systems in just one week. This gave the Research Coordinator a week of their time back in which they could focus patient visits and enrollment without delay. It was a huge relief for the site, and it helped keep the study moving forward.

Gastroenterology Site in FL
This site was really struggling — they had a new Coordinator every month, lots of protocol deviations, and many screen failures. I went onsite and trained the team, worked closely with site management to create a strong workflow, and tackled operational challenges like organizing visits, fixing fridge and freezer issues, and cleaning up the research space. Now, the site has two long-term Coordinators, five active studies with four more coming up, and a sister location ready to conduct research. They are now one of our top enrollers for pretty much every study the participate in.

Q: What advice do you have for PIs and Coordinators working with CTNx?

Mikayla’s Advice:

  • The right team matters. Having qualified and dedicated staff is essential to conducting successful research and ensuring studies stay on track.
  • Clear communication drives success. Stay in regular contact with CRAs, study teams, and CTNx. Strong communication between all parties leads to smoother execution and better outcomes.
  • Know your patient population. Make sure your site has access to the right patients for the studies you’re applying for — this helps maximize everyone’s time and increases the chances of enrollment success.

Sophia’s Take:

  • Communication is key. We’re here to support you — the more you engage with our team, the better we can guide you in building a successful research program.
  • Preparation matters. Before seeing real patients, take time to prepare for visits, ask questions, and run through test scenarios. It makes a big difference.
  • Training and onboarding can feel overwhelming at first, but they’re designed to lay the foundation for your long-term success with CTNx.

Big Shoutout to Sophia and Mikayla for breaking it down! Thanks for sharing your insights on how CTNx supports its research sites and what it takes to build a successful research program.

Helping Clinical Research Sites Start Strong: Meet Kevin Ignasiak, CTNx’s Site Engagement Officer

Blog post image about Helping Clinical Research Sites Start Strong: Meet Kevin Ignasiak

First Things First

Starting a clinical research site is no small feat. Between startup documents, regulatory hurdles, and the long wait for that first trial, many practices underestimate what it really takes to break into research and stay in it.

That’s where Kevin Ignasiak comes in.

As CTNx’s Site Engagement Officer, Kevin works directly with new research sites to demystify the startup process, set realistic expectations, and lay the groundwork for long-term success. With experience both as a site coordinator and sponsor liaison, Kevin brings a 360-degree view of what it takes to build a reearch site from the ground up!

We sat down with Kevin to talk through the biggest misconceptions new sites have, what to expect during onboarding, and why he believes CTNx is changing the game for private practice physicians who want to get involved in research.

What does a Site Engagement Officer actually do?

“My goal as CTNx’s Site Engagement Officer is to educate, guide, and coach new research sites that join our network. Getting your research staff up to speed, collecting the right credentials, and landing your first study takes time and effort.

I walk sites through this process so they have the best chance of getting their research program off the ground quickly and effectively”

What happens when a site first joins the CTNx network?

“Everything starts with an onboarding call. I use that time to get to know the site and their team, and to walk them through what the first few months will look like.

A big part of my role is setting expectations. A lot of new sites think they’ll be up and running with a study in just a few weeks but that’s just not the case.

After onboarding, CTNx begins collecting required documents like medical licenses, CVs, Good Clinical Practice (GCP) certifications, and preparing the eRegulatory system. Only when those are in place can sites start being submitted for study opportunities.

What’s a feasibility and how does a site get submitted for a study?

“To be considered for a study, a site needs to complete what’s known as a feasibility questionnaire. It outlines a site’s capabilities, credentials, past research experience, and relevant patient population.”

Kevin works directly with sites to gather this information and then handles the actual submission to the sponsor.

“Once we submit the feasibility, we wait. Sometimes responses come quickly, but more often it takes 2 to 4 weeks to hear back.”

What if the sponsor is interested in a site?

“Then we move into the pre-selection visit, or PSV. This is where the sponsor visits the site to assess its facilities, staff, and overall readiness to conduct the study.”

Kevin preps each site for their PSV in advance explaining what questions to expect and how to run a successful tour.

“I also join every PSV and stay for the entire visit, helping answer any sponsor questions about CTNx”

What are the two biggest things you focus on with new sites?

1. Setting Expectations

“It’s important that investigators understand what it really takes to land that first study. It can be a grind, but once you land one, more usually follow. I also explain what CTNx can take off their plate so they don’t feel overwhelmed.”

2. Keeping Investigators Engaged

“PIs have to stay involved. That means oversight of the process, quick responses to study opportunities, and being ready for the next step. Sites that are consistently responsive win more studies—and build more profitable research programs.”

How do you tailor your support for experienced VS naive sites?

Experienced Sites: “Some investigators have run 30–40 trials before. They know what they’re doing. I don’t over manage them they just need us for the heavy administrative lifting. They move fast and come to me as they need.”

Naive Sites: “Newer sites need more hands on help. I spend extra time walking through what’s required, checking in regularly, and making sure they’re not stuck on things like GCP training, SOPs, or feasibility forms.”

“I also try to match my style to the investigator. Some want step-by-step guidance, others just want a checklist and space to do it. It’s all about understanding what they need.”

How long does it usually take to get a site up and running?

“Generally, 6-12 months. The biggest factor is how quickly the site completes onboarding tasks and how engaged the PI is. Sponsors often move fast when they need sites, responsiveness is crucial. If I send you a study and you reply three weeks later, you’re likely out of the running, but if you respond in 24–48 hours, you’ve got a much better shot.”

Kevin also reminds sites not to get discouraged.

“Even if you don’t get selected after a PSV, keep applying. It might take six months to a year to land your first trial.

Stay engaged and you will see results.”

What was it like starting in research without CTNx?

“I wish I had CTNx when I was a coordinator. I had to do everything—regulatory, IRB submissions, redlining protocols, patient outreach, scheduling, visits, labs, audits… you name it.”

Even when Kevin had partial support in later roles, it wasn’t enough.

“CTNx gives you the time to focus on patients and studies instead of paperwork. That translates to better data, more patients helped, and smoother operations all around.”

Do This, Not That : Advice from Kevin

✅ Do

Build a team that’s genuinely interested in research. Make sure everyone understands their responsibilities. Stay committed to patient care it shows, sponsors notice when sites are engaged, professional, and care about outcomes. That’s who they come back to.”

❌ Don’t

Pick a trial just because of the payout or
Assume your coordinator can do it all without support. Then don’t lose sight of your why!

“When I worked on gene therapy trials, I loved the work because it helped patients. When I moved into high volume vaccine trials, it started feeling like a profit machine and that affected how I felt about the job.”

If you could have dinner with anyone in medicine or science, who would it be?

In medicine:

“Dr. Jerry Mendel. I worked with him on gene therapy for SMA and Duchenne’s Muscular Dystrophy at Nationwide in Columbus. He’s a pioneer with over 50 years of experience and made a massive impact on patients. I’d love to hear more about his journey and how he got into the field.”

In science:

“Louis Pasteur. I’d want to hear about the origin of vaccines and share what they’ve become today. I think he’d be blown away with todays advancements.”

Final Thoughts from Kevin

“If you’re running research or thinking about it take a serious look at CTNx. We help you take on more studies without drowning in admin work.

Investigators in our network are excited because they know how time consuming research can be. We make it easier, and I love working here, I think a lot of other research professionals would too.”

Ready to Start Your Research Program?

Kevin’s story says it all, launching a successful research site takes work, but you don’t have to do it alone. CTNx provides the structure, tools, and support to help you go from idea to activation.
Thinking about bringing research to your practice?

Now’s the time!

Reach out to us today and let’s get your program off the ground!

Start Optimizing Your Research

How Clinical Research Can Save Lives: The Story of Tina and Malachi Anderson

How Clinical Trials Can Save Lives :

The Story of
Tina & Malachi Anderson

Tina, when did you first discover Malachi had Spinal Muscular Atrophy (SMA)?

Tina: Malachi was born perfectly normal; he passed all his APGAR tests. Two months into his life he began to lose function and couldn’t lift his head, arms, or legs. He wasn’t meeting the milestones a 2-month-old baby would typically make.

People would say things like “he’s fine”, “he’s a boy”, “he’s lazy”, or “he’ll get there”. However, my mom-intuition told me something wasn’t right. I called our pediatrician and got Malachi in for an appointment the next day. He wasn’t sick, but something was off.

An hour or two after the appointment the pediatrician called and based on the severity of Malachi’s symptoms, he scheduled another next day appointment for Malachi at Nationwide Children’s Hospital in Columbus, Ohio. The next day, we spent four hours at the appointment. Mal’s blood was tested, and he underwent an exam to evaluate his strength. We waited 10 days for a follow-up appointment call.

Our next appointment, a bomb was dropped. We found out Malachi had Spinal Muscular Atrophy (SMA) type 1, a severe genetic condition affecting infants. At the time there weren’t really any treatment options for SMA and most children with SMA didn’t live past two years old.

With that being the case, I started to search for clinical trial options. The first study I found was SPINRAZA which was a spine injection every three months, but it was a placebo-based study located in Chicago. That would have been extremely difficult as we’d be removing Malachi from his family and potentially receive a placebo which was too much of a risk.

Eventually I discovered a study in Columbus for an open-label gene therapy with no placebos. I fought hard to get Malachi into the trial. Somedays I was calling Nationwide Hospital 14 to 15 times a day. A doctor on the team for the gene therapy caught wind that I was calling and told her team “We must get every newly diagnosed child in these doors as soon as possible.”

After 26 days of testing, Malachi qualified for the gene therapy trial. He was dosed on December 2nd, and he was just shy of 4 months old. At the time he had lost nearly all mobility. His hands were down at his sides, and he could barely move his feet

Did you have any apprehension about enrolling Malachi in a clinical trial? And if so, did anything change your mind?

Tina: It was slightly traumatizing as we had to sign an autopsy form. God forbid Mal didn’t make it, they would do an autopsy to see if it was related to the gene therapy or 100% SMA. I wasn’t sure if I could go through all of that. My husband and I went into deep discussions and felt pressure to move quickly due to Mal’s condition. We felt if we did the trial – Mal possibly lives, gets stronger, and lives a healthy life. If we don’t do the trial – we risk Mal not making it at all.

There was nothing we could do to keep him here with us other than palliative measures. Kids with SMA are very cognitive, they hear and understand everything, and we couldn’t do that to him. It was scary, we didn’t know what the drug would do short term or long-term.

That does sound scary. Was there anyone that supported you during this process?

Tina: We had Chris Petek (Now CTNx COO) who was on the trial’s research team at the time. Chris was incredibly supportive. I can’t imagine the process without him. He was always there to say, “Hey, these are the gains we’re noticing for other kids”. Chris was encouraging, but not pushy.

It was a life-or-death decision and there were times we spoke to Chris at midnight. We would think of something and call or text him. And Chris always made himself available to us.

How were you feeling going into the trial after Malachi got accepted?

Tina: It was nerve-racking. You go into it blindly and don’t know the other families in the study. Mal was patient number 14 out of 15 in the entire world to get the drug. Slowly we figured out who the other families were as their children looked similar; it felt like we found each other

What stood out the most during the clinical trial, and how did it alter your view of clinical trials as a whole?

Tina: After Malachi’s first dose, we saw progress within the first 12 hours. For us, it was magical, I know that’s kind of a weird word to use, but it was. We had no idea what to expect after him being still for so long. It truly was magic.

Can you tell us about the drug Malachi took?

Tina: ZOLGENSMA is a one-time dose gene therapy that helps sleeping motor neurons essentially regenerate so patients can gain muscle and strength where the mutated gene had killed off the neuro genes.

Has Malachi seen any long-term gains
from the treatment?

Tina: Nine years later, we’re still seeing growth, but back to those first 12 hours, Mal showed more leg movement than in the prior two months! He began rolling and would roll down the hallway as his mobility continued to improve. The hardest thing for kids with SMA is head control and strength in general, which is still a struggle today, but it’s got a lot better. Before Malachi would have never been able to propel himself in his wheelchair, now he does almost all day at school. Malachi can now do wheelies and everything in his wheelchair, so he’s happy!

I keep 1-2LB weights at Malachi’s desk to lift when he sits to maintain what he’s gained. He loses strength after rod surgery; the rods are placed in his shoulders. Malachi will have annual check-ups until he’s full grown, followed by huge spinal fusion surgery.

What advice would you give to someone who has recently been diagnosed with
Spinal Muscular Atrophy?

Malachi: Never give up.

Tina: Get treatment as quickly as possible. There’s been great results with ZOLGENSMA. Early treatment can stop babies from showing symptoms of SMA and offer a chance that they never see symptoms at all. They can potentially hit milestones and be able to walk, run, and climb on time if they’re dosed. We got it during trial and didn’t pay for it, but I would have sold everything I had to get my son what he needed.

Malachi, can you tell us how old you are and what grade you are in

Malachi: Nine and I am in fourth grade.

Is there anything exciting going on in school?

Malachi: Recently my mom came in and talked to my fourth-grade class. I helped her talk about advocacy because I often advocate for myself.

Tina: Yes, the school asked me to come and speak on the importance of advocacy, for yourself and others. It’s opened doors for Malachi. It’s a way for the kids to better understand a day in the life of Malachi.

We brought 3 wheelchairs in and kids could spend a portion of the day in the wheelchair and see what it’s like trying to navigate the day. We hoped to teach empathy and compassion for other’s differences. We’re currently working with the school on a huge project for more accessible outdoor areas. Malachi’s whole grade has come up with ideas!

What are your favorite technologies or tools that have significantly improved
Malachi’s quality of life.

Tina: Mal’s growing rods have been huge. Prior he was so tiny, he almost looked malnourished. Every two months I take Mal to Columbus to have the rods lengthened. They use a machine that finds a magnet which then turns and lengthens the rods which are on each side of his spine.

At one point his spine’s muscle mass was so low; Mal’s spine was basically C-shaped. It affected his breathing, and he couldn’t eat. He was constantly hungry and could only take a few bites of food before he was full as there was nowhere for the food to go. Getting enough nutrients and gaining weight was nearly impossible. Now he eats because he’s bored.

A downfall of the rods is losing strength each time he has surgery and building it back. The rods also help breathing, most SMA kids have lung issues because of low muscle tone. It’s all worth it though, Mal gets independence, even small things like being able see out the car window.

What would you say are some common misconceptions about Spinal Muscular Atrophy and what do you wish people understood more about it?

Tina: The biggest misconception about children with SMA is that they can’t be independent. Insurance often dismisses requests for necessary equipment, assuming these children are bedridden and ventilated. SMA children that are not treated by two years old must be ventilated and can’t eat or breathe on their own and are fed through a G-tube. Despite the fact that many treated SMA kids are able to do things, it’s a fight every time we need something. Even things like a new wheelchair, they’ll try to say, “it’s not needed” or “They’re bedridden” and that’s not the case.

People assume SMA kids are not capable of doing things. Malachi is a great example. He has come so far. Malachi even helps me in the kitchen and aspires to be a chef like my husband, who was an executive chef at Landoll’s Castle and Malabar’s Farm restaurant.

Malachi are there any special dishes you’re trying to learn right now or enjoy to eat?

Malachi: I want to try making chicken and Mexican rice with corn. Also, I recently made maple glazed pork chops, but I like eating steak and potatoes or sushi!

Tina: He’s an expensive child. Mal has been eating sushi since he was like two. My other kids won’t touch it.

Malachi what are some other hobbies or things you like to do?

Malachi: Gaming. I’m good at it! Also, reading and biking.

Tina: A Foundation out of Columbus called Christopher’s Promise helped us. They came up with the money and donated a bike for Malachi. We’ve ridden that quite a bit.

How has SMA influenced your perspective on life or your personal goals?

Tina: It’s made us all more compassionate people. We’ve always taught our kids to be “bucket-fillers”. If you see someone struggling, help them. Whether you are friends or not, inclusion is important. That’s why I’ve got into advocating at Malachi’s school. Everyone should be able to feel included.

A girl at his school, came up to me after I spoke at his school and said, “I’m different, but I’m different on the inside.” She kind of looked around nervously before continuing “you made me not afraid to speak about me.” She’s 9 and has diabetes. Malachi’s story helped her feel comfortable. We all battle something, so we strive to be compassionate, empathetic, and caring toward others.

As someone living with SMA what have been some of your most memorable or meaningful experiences?

Malachi: I got baptized. I didn’t want to at first, but I changed my mind. It feels like a great achievement.

Tina: Three years ago, Malachi’s good friend Payton was in a car accident and passed away. At her funeral our pastor spoke about picking up the mantle from where Payton left off and to love and live like Payton did. That day Malachi’s decided to be baptized on his own as he was listening to Payton’s favorite song to sing “ain’t no grave that will hold my body down.”

We believe God planted us where we needed to be to get into that gene trial. There was a time when Malachi was first diagnosed, and my husband and I were angry at God. We thought “why would you do this?” Then one day I remember saying to my husband, “Torrence, we must give Malachi to god or Malachi’s life is going to be in vain.”

We prayed and two days later we got a call from Nationwide about participating in the study. It was crazy because they scheduled his first appointment on the anniversary of my mother’s passing. At that point we felt “God has got us” and my mom was our guardian angel. From there, it was wild how fast everything started happening.

Gene therapy is what saved Mal’s life ultimately, but I don’t know we would have been put on that path if we didn’t follow our faith.

We want to express our gratitude to Malachi and Tina for taking the time to meet with us and share their journey in clinical research. They provided valuable insights into living with SMA and how participating in clinical research significantly impacted Malachi’s life. Thank you both!

CEO Interview Dr. Keith Friedenberg

12 Questions with the Clinical Trials Network’s Founder & CEO –Dr. Keith Friedenberg

Dr. Keith Friedenberg, thank you for sitting down with us. How did you get started with research?

About 20 years ago I was approached by a pharmaceutical company to participate in a trial evaluating a higher dose PPI for heartburn. I had done a little bit of research during my fellowship, but nothing after. Fortunately, I had a friend who was a clinical trial nurse at a large institution in her previous career and was looking for part-time work. The timing aligned perfectly, and everything just seemed to fall into place.

We know you love research. Was that the case from the start?

It was. I found it extremely interesting as we were exploring drugs and devices that ended up being viable treatment options for indications that never had a treatment. It was exciting to be part of clinical advancements, seeing the impact on patients who finally found relief, as well as helping bring a bunch of new treatment options to market. 

In addition to the emotional and intellectual sides of research that I found stimulating, there was the business side. Adding research to our practice also resulted in a substantial new revenue steam that has aided in the overall growth of my practice over the years.

You currently have several partners at your practice doing research. Did they start at the same time as you or follow suit after?

Initially, I was working solo. When my first partner took interest and came on board, my research experience set me apart from other job opportunities he had encountered. That has turned into consistent trend over 20 years that almost all interviewees had a higher preference to our practice because of the uniqueness of having a robust clinical trials program in the private practice setting.

Today I have 4 partners who are physicians that are all participating in research and 5 research coordinators. At any point in time, we might have 20-25 studies going at our practice.

What are some of the larger challenges you ran into when you were starting the research program at your practice?

When I originally started my research program our research coordinator handled pretty much everything relating to research. On top of seeing patients the coordinator would also handle the regulatory paperwork, compliance, data entry into the Sponsor’s electronic data capture (EDC) system, sponsor invoicing/payment reconciliation, marketing and more.

When we were starting out and only had 1-2 studies going, that workload was fine for a single coordinator. When we started getting 3-4 trials at a time a single coordinator wasn’t enough.

Several years in I brought on Chris Petek who came from an allergy clinical trials network. Chris introduced me to a consolidated model in which we delineated tasks, and it worked quite well. One person does the regulatory, one person does the compliance, one person does the electronic data capture (EDC) upload, another person handles the sponsor invoicing/reconciliation and so on. 

Out of the model Chris and I formed the Clinical Trials Network. We thought “what if we could have a team that offloads each of these tasks for a research site”. Not only would it be a plug-and-play model that would allow them to obtain instant research infrastructure, but it would also significantly reduce the load of work, making it easier for a practice to add on a research arm. 

Today I have 4 partners who are physicians that are all participating in research and 5 research coordinators. At any point in time, we might have 20-25 studies going at our practice.

Were there any other challenges that you ran into when you were trying to get up and running.

Yes, the biggest challenge in research is often finding the patients. There is no predictable pattern, so there are times you are too busy or not busy enough, particularly on the coordinator side. Another challenge is the performance of the coordinators, you must have a coordinator that has a good head on their shoulder, is engaged, and can stay on top of things, because their work is such a crucial role. 

Delayed payments are also a very common frustration. You have to accept the fact that you earned it, and you’ll get 100% of what you earned. You may not get it as soon as you want, and that can be frustrating for new investigators.

What initially inspired you to start the Clinical Trials Network?

Another big challenge is getting to a critical mass in clinical trials. When we started out the industry was much more “mom and pop” back then, and it was hard to get on the sponsors’ radars. By the time you found out about trials, they were already up and running. It took a lot of work going on websites, approaching companies you read about, and many calls to find trial opportunities. You really had to carve out a path to create opportunities. Overall, it felt like everyone in the industry was recreating the wheel and it’s still that way today. I started to think “Why can’t we do this together?”

Another major factor was a flaw with the Sponsor’s approach, only experienced sites were brought opportunities and new research sites were excluded. For example, the IBD space has a vast variety of medicines to successfully treat IBD and trials kept coming for new treatments. The problem with only using experienced sites is that you start running out of patients when going to the same research sites over and over. We needed to give new sites a chance to get involved.

Supporting and recruiting new physicians also created greater access to other patients that also need new treatment options. Ultimately, helping trials flow faster and better!

What About CTNX sets it apart from other trial management partners?

CTNx offers one of the widest arrays of trial management and support services, we go beyond just finding trials and negotiating budgets. We have a “boots on the ground” approach and provide constant communication and training. In addition, our compliance program and team is amongst the best. They provide oversight of the work that’s being done and make the process go smoothly and efficiently from the monitoring side. We keep the data pristine for our CROs. Compliance also serves as a training tool for coordinators and physicians. 

I firmly believe we are one of the best networks for new physicians to affiliate with. From a financial perspective, we deliver the highest percentage of dollars in the practice’s pocket. And in the end, we’re physician-founded. We think through the eyes of the PI’s just as if we were the ones performing the research.

What has been the most interesting or impactful study you have taken part in your career?

Well, I’d say there have been multiple trials that have been interesting. Particularly I enjoyed the vibrating capsule for constipation, a first-of-its-kind therapy that helps to stimulate colonic motility from inside the body that was approved back in 2022.

I enjoy my studies in IBD, especially the earlier ones that shook up the traditional treatments and allowed me to witness patients get dramatically better. The large volume screening trials are great as we can engage people without diseases into research. Those are just a few off the top of my head. 

Are there any specific impacts you felt you have made during your research experiences.

I think the biggest impact is with the more difficult-to-treat diseases. In my opinion, participating in IBD trials for patients with severe IBD and then monitoring them through a long-term extension study is fulfilling. It’s especially rewarding considering the daily impact I felt I was able to make on many people’s lives.

What changes would you like to bring to the industry?

To start I would focus on communications between the sponsors, CROs, and the sites. I would make communications streamlined, simplify the financial processes, and ensure timely payments to the sites completing the work. Unfortunately, delays in payments can hinder site and physician engagement.

Also, the inclusion and exclusion criteria is very challenging, and while much of that is directed by the FDA with good reason, it makes recruitment harder and completion of trials within a reasonable timeline. In selected instances, if practicality could come into play more with the inclusions and exclusions. That would ease the path forward.

Additionally, I’d like to see patients get compensated more. From my experience offering clinical trial opportunities to thousands of patients, the value of someone’s time in today’s world has gone up significantly, and the stipends which are designed to compensate them for their time is too minimal to appropriately thank someone for giving up their time.

How do you think the industry will change in the coming years?

I think like most industries, it will continue its evolution from a “mom-and-pop” industry to a consolidated industry of larger entities. Essentially there will be large companies who own or manage multiple sites (perhaps private equity-backed).

Also, I think that it will continue to get harder to find the patients who fit inclusion and exclusion criteria. Overall, finding patients is expected to become more demanding, and the effectiveness and sustainability of sites relies heavily on patient recruitment.

Do you have any advice you'd want to share for any physicians interested in getting started with research?

I truly believe in the benefit of collaborating with a network, where you are a part of a larger team. This approach saves time that would have been spent on building your own infrastructure and gaining access to opportunities that might otherwise take years to secure and discourage you from hanging in there.

I would make sure that you have an excellent coordinator and be patient with your willingness to learn. Last, be open and accept the guidance from the individuals in the industry that you’ll meet along the way.

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6 Questions with Dr. Carlile

6 Questions with Dr.Carlile

6 Questions with Dr.Carlile

An interview with one of the Clinical Trial Network’s 

top performing Neurology researchers

Q: What sparked your interest in clinical research?

A: Clinical research allows me to be at the forefront of neurology so I can enrich my understanding of the conditions affecting our patients and offer them the best care possible.

Q: How did you get started with research?


A: Our multi-specialty practice had established a primary care research base with CTNx and I was able to use their experience to build my own research career.

Q: What were some of the biggest barriers to getting started?

A: Getting our first few studies was the most difficult. We had to convince sponsors that we had the capability and patient population to enroll patients and be good stewards of the protocol. 

Q: Are there any recent studies that you are particularly proud of or made a major impact for your patients?

A: Our pediatric migraine study has highlighted the lack of therapeutic options for that population and has been very rewarding.

Q: If you were to give advice to another doctor looking to get started with clinical research, what advice would you give them?

A: Research is often demanding and requires attention and vigilance. If you have the interest and desire to do clinical research, it can transform your practice and allows you to offer potential treatments and diagnostic options for patients that don’t exist in the surrounding community.

Q: How has working with CTNx made an impact on your research program?

A: CTNx has taken the regulatory and many logistical burdens off of our site and allowed us to focus on the aspects of clinical research we are most passionate about. The connections with sponsors that CTNx offers is invaluable.

Dr. Carlile’s experience in clinical research and dedication to serving patients is truly commendable. Thank you for being part of the Clinical Trials Network and making a significant impact in the neurology world.

– The CTNx Team

Contact us if you are interested in getting involved in clinical trials.

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The Clinical Trials Network (CTNx) Partners with SelectIQ to Revolutionize Patient Recruitment for Clinical Research Sites

The Clinical Trials Network (CTNx) Partners with SelectIQ to Revolutionize Patient Recruitment for Clinical Research Sites

 

The Clinical Trials Network (CTNx) has forged a strategic partnership with SelectIQ to transform patient recruitment for clinical research sites. SelectIQ offers an innovative software that seamlessly integrates with a practice’s Electronic Medical Records (EMR) system, harnessing the power of artificial intelligence to analyze patient records. This technology flags individuals whose medical history aligns with the criteria for participation in a clinical trial, ranking them based on their likelihood of participation.

CTNx enhances this process by providing additional support to research sites. Their team conducts outreach, calling and pre-screening potential study candidates to ensure they meet the necessary qualifications. Utilizing an Institutional Review Board (IRB) approved script, qualified candidates are identified and referred to the research site’s study coordinator for an in-person screening and study enrollment.

Christopher Petek, Chief Operating Officer of The Clinical Trials Network, expressed enthusiasm about the partnership, stating, “Patient enrollment is paramount to the success of any study and research site. We are excited to leverage this cutting-edge technology to empower our research sites, streamlining the identification and enrollment of qualified patients in clinical trials.”

Ethan Bond, Chief Executive Officer of SelectIQ, shared that “SelectIQ empowers healthcare providers to connect their patients with relevant clinical trial opportunities. CTNx is a natural collaborator given their success bringing trials into community healthcare practices. We’re proud to support their important work.”

Research sites keen on optimizing their clinical trial enrollment processes can learn more about CTNx’s offerings by visiting their website at www.thectnx.com or requesting to schedule a live demo through the following online form

 

About CTNx

The Clinical Trials Network (CTNx) is a network of private practice research sites committed to enhancing access and diversity in clinical trials. Since its establishment in 2018, CTNx has facilitated the opening of over 90 research sites spanning various medical specialties, including Gastroenterology, Ophthalmology, Dermatology, Allergy/Immunology, Pulmonology, Neurology/Psychiatry, Cardiology, Rheumatology, Endocrinology, and Women’s Health.

CTNx is renowned for its comprehensive centralized administrative support and its in-house program for identifying and training clinical research coordinators, assisting both novice and seasoned investigators in navigating the clinical trial landscape. For more information, visit www.thectnx.com.

About SelectIQ

SelectIQ is a Provider Activation Platform that reduces burden on healthcare providers who wish to make clinical trial opportunities available to their patients. Founded by industry veterans from data and AI firm Palantir, SelectIQ brings a wealth of expertise in clinical data analytics, security, and governance.

The team has a proven track record of developing robust software solutions for esteemed organizations, including intelligence agencies, academic medical centers, and leading pharmaceutical companies. Notably, SelectIQ’s founders played instrumental roles in crafting the data governance systems safeguarding clinical data within the National Institutes of Health’s COVID research platform and the United Kingdom’s National Health Service (NHS). For more information, visit www.selectiq.com.

Interested in SelectIQ and working with us ? Contact us today!

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