Starting a Clinical Research Site: An Interview With Kelly Willenberg

Narrator: This is the DarshanTalks Podcast, regulatory guy, irregular podcast, with host Darshan Kulkarni. You can find the show on Twitter @darshantalks, or the show's website at darshantalks.com. Darshan: Hey, everyone. Welcome to another episode of DarshanTalks. We have a crowd favorite with us today. We have Kelly Willenberg. And for those of you who don't remember, Kelly is the go-to expert as it relates to billing compliance, and in the context of helping develop a clinical research program. Most recently, Kelly got nominated to the board, I believe, of HCCA. Is that correct, Kelly? Kelly: That's correct. Darshan: And can you tell us a little bit more about yourself, and what is HCCA? Kelly: So I am a nurse who has been in the research compliance industry since I started in 1984. So now everyone knows how old I am, which is kind of scary. But as a nurse, I came up through the ranks doing research, from being a research coordinator at a hospital taking care of sick and dying children on cancer studies, to helping the profession of healthcare compliance throughout the years and producing educational opportunities for people so they can learn about how to set up practices and how to do billing compliance right. So as a nurse, I bring the medical knowledge that is needed to do that. But I mean, having the experience, I think, is a little bit different than some of the people that are out there that bring knowledge to the table. It's the fact that I've actually done almost every job in the healthcare industry around clinical research, having run a clinical research practice and large academic medical center. And you ask about Health Care Compliance Association. So it is a organization that was established in 1996, that is a member-based association for healthcare compliance professionals. They do everything from conferences to publications, and a certification for healthcare compliance; healthcare research compliance and healthcare privacy compliance. And it's a way to stay connected with our peers across the world in compliance to help continuing education and develop better standards in a compliance program from across healthcare compliance to the society of ethics. So it's a healthcare compliance community that I bring my knowledge to the table to for the next three years as a board member. Darshan: Well, they're going be really lucky to have you, is what I have to say about that. So let's sort of jump into it a little bit, Kelly. So my first question is, in the context of clinical research, when does the average person approach you? When are they usually going, "I don't think I've got this figured out?" What is the thing that they haven't gotten figured out? Kelly: Well, we have a lot of things that people bring to our attention, but I would tell you that a couple of the areas that we really do a lot of work in, and you and I have had a podcast in the past about, of course, clinical trial billing compliance. And when they find that they've got an issue, or they have questions about how that billing process goes, from the coverage analysis through the claims process. But we also have a lot of clients that seek our help in establishing or reorganizing their clinical research office. And that can be rather challenging if you really don't have the knowledge or the bandwidth to actually know what you need in the form of a structure to actually go out and seek clinical research and bring it in to your facility, whether you're a practice or a small hospital facility that thinks that they want to do research. Darshan: Now, in your experience, do you find more clients who are standalone small doctors offices calling out to you, or is it often large academic medical centers,