It’s no secret that the world of clinical research organizations is a crowded one. With so many CROS vying to manage worldwide clinical trials, bid defenses and sales pitches can become quite the headache when you’re ready to bring your drug into the testing phase. What do you look for in a capable CRO? Plenty of resources are key, of course, as is a good track record, but what really separates a good from a great CRO is the experience the team brings to the table.
Nobody understands the importance of clinical trial experience better than InClinica’s Senior Project Director, Myra Frick. With over 20 years working in CROs, Ms. Frick has guided drug trials through testing across numerous areas of medicine. She understands and has perfected the art of guiding clients through the initial stages of their trials. When you work with InClinica, you can immediately expect all the support and resources you will need. Ms. Frick explains the onboarding process and how those early stages work:
I handle the in-depth logistics about a project, getting to know the specifics the clients want to see. Someone from our business development team might meet someone at a conference, introduce InClinica as a global CRO, describe the aspects of clinical trial operation in which we specialize, and identify the clinical development needs of the potential client. Once we identify those potential clinical studies for which we want to develop a proposal, that’s when I get involved.
I’m in project management. I’m here to help set the scope of a particular project, hone in on the details of the proposal, develop the budget, and help manage the project as it progresses.. A lot of what I do is manage the relationship between clients and our operations team. At this early stage, our operations team is involved when we have new client discussions, when we’re formulating the overall study plan, and when we propose a study design and resourcing, All of this goes into a proposal.
Early in, I have the most interaction with clients, and I then help them transition to working with our clinical operations team. That’s where the study really kicks into full gear. I handle the initial client phone calls. I work with clients to discover their general objectives of the study,, what protocols are already in place, what the budget is—all those initial pieces. I try to answer questions like these before the operations team takes over. I glean all of these details to help the proposal team draft their, well, proposal.
It’s definitely collaborative. First I need to understand what a potential client wants and needs. That may involve our entire team. At this point, I may include our Chief Medical Officer Ed Brennan. I may include our clinical operations team. But if the client has a pretty fleshed- out idea, a protocol, or something along those lines, then oftentimes I can have that initial discussion because many of the details have already been addressed. I can put the trial into context and bring it back to our team.
Our recommendations come more at the point when we’re developing the official proposal. That initial discussion with a client is more about answering the questions “what are your objectives and how do you envision getting there?” I take this information back to our team and, based on a client’s objectives, we’ll analyze what may or may not work. Sometimes we might arrive at a different recommendation that we feel is a preferred option based on our experience. The bottom line is that our recommendations really come in at the proposal stage or a bid defense when we get to have an in-depth discussion with the potential client.
I’m involved from start to finish. I’m very involved initially. When the study actually begins, that’s when there is a lot more operational interaction. My counterpart, Teresa Byrne, speaks with the client about their protocol, potential IRB issues, and study implementation while I maintain contact from a business perspective. Do we have a contract agreement? Are our work orders completed? How is everything with invoicing?
I shift over to that side and allow the operations team to demonstrate their expertise and maintain the face-to-face interaction. Having different team members involved in different capacities keeps trials running smoothly—no one team member is doing too much and nothing’s getting lost in the process.
I’ll give you our “elevator pitch.” What we do differently is bring in world-class experts in specific fields who can offer contemporary, practical advice. Our network of experts is pretty impressive. If you want to do a study on a dietary product, for example, we’re able to point to some of that industry’s experts. We know the right people across every therapy area and every drug development discipline. Now, we may not always introduce them to the client. As the InClinica team, we might meet with experts and consult them—serving as the conduits between them and the client. That’s far and away what InClinica offers that’s different than other CROs. It’s that access and ability to consult leading experts in a vast number of fields and specialities in virtually any therapeutic area.
Having a network of industry and academic experts like this definitely isn’t the norm among CROs. I’ve worked at other CROs and they may have someone on-hand to consult periodically, but not on a regular basis. A lot of this industry is “who do you know?” and bringing renown to the table. That’s what inClinica can do. We can get to these key opinion leaders (KOLs) in many different fields and industries. Most CROs, if they’re on the larger side, have people like that on staff.
When we talk about who and what InClinica is, we talk about our executive-level management team and what they bring to the project, where our experts are, and what make them so strong. It’s largely because of the diverse experiences everyone at InClinica brings with him or her. Principally, our CEO James M. Nolan. Jim’s got an amazing Rolodex. He has every contact you’d ever need. That’s what he does; he’s a connector. He has contacts literally all over the world. We’ve all been in this business a long time, both on the ground and at different CROs. Jim can pick up the phone or send an email and he’s going to get a response.
The CRO industry is intensely competitive. What we do is highlight and emphasis those connections—we don’t leave it in background. When I’m working on a proposal with my team, I’m making sure our expertise, contacts, and experience are highlighted and prominent. I want potential clients to immediately know who our relevant contacts are and how we’ll leverage their knowledge to help their trial.
We have both; some of us at the same time. . In some ways we’re all generalists—just from the collective years we’ve all been in this field. However, everyone certainly brings specialities. Some of us have deep knowledge of a therapeutic area AND a mastery of clinical trial logistics and the intricacies of starting a trial. We highlight individuals’ expertise and give examples of how they’ve run successful trials in those specific areas. For example, I’ve done a lot of work with schizophrenia, CNS, epilepsy, and migraines. Anything along those lines, I’m a go-to person. Anything that has to do with a surgical procedure or application, Ed Brennan would be the in-house expert, or Teresa Byrne for respiratory diseases.
Our specializations are never a hindrance. We all look at every project and determine where our individual backgrounds can lend the most support. Depending on what the trial entails, we’re going to find the person at InClinica who most closely matches the field experience. As I said, we’re also generalists. Having been at many different CROs, it familiarizes you with all types of different fields.
I think people in pharmaceuticals tend to stay in a specific area for a while. I worked at a CRO where I worked on drugs aimed at treating very different diseases. So, depending on the project, we leverage who has the best experience.
Learn more about the specific expertise, experience, and what key opinion leaders can bring to your drug or device trial. Visit the InClinica contact page to get in touch with one of our regional offices.