Starting a Super Successful Trial Site: An Interview with Deena Bernstein

Narrator: This is the DarshanTalks Podcast. Before this week's interview with Deena Bernstein on starting a super successful trial site, Darshan will introduce this episode with the recap for the week of Thursday, May 21st, 2020. Darshan: This week has been an interesting week from a news perspective. Things seem to be taking a turn, companies that were investing into vaccines saw a potential return because there was hope, and the hope then got snatched away. However, I've been speaking to other companies that are all talking about bringing some version of vaccines or therapeutic products to the market. So the general rule seems to be that companies in the life sciences still seem to be proceeding exactly the way they wanted. However, they are in some senses looking forward to accelerating as soon as the market's opened up in terms of the coronavirus allowing people to move around. Darshan: However, this has also resulted in some ramifications to companies that you hadn't considered. The event market for example. I did a podcast recently with Kelly Willenberg, who's going to talk about some of the experiences around marketing using events. So stay tuned for that. It's been a really interesting couple of weeks especially going from no changes all the way to seeing some hope and seeing that hope snatched away, and that is science. If this is not the example of how science actually proceeds, I don't know what is. People expect that the first drug you try works, people expect that the first vaccine you create might be ideal. And obviously everyone hopes that that's what it is. The entire world is literally looking forward to that. However, sometimes that doesn't quite work out. And I'm hoping that for all of our sakes, things get back to normal quicker. Events and event planning companies themselves are being hurt however, and it has resulted in the opportunity to talk to multiple people, there have been more zoom meetings. Darshan: So, overall what I've got is that, from a compliance perspective, this is a really good time to look back at your own efforts and take a step back and evaluate if all the steps were in place. If there weren't, you need to consider about why they weren't in the right places and fix those changes. If there's something else going on, maybe this is the opportunity to look back at your audit program and evaluate things that, the last time you did the audit you found problems. If you have questions, if you have concerns, feel free to reach out to me at, [[email protected] 00:02:34], that's [email protected]. I'd love to talk to you further. 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 special guest, we have Deena Bernstein. And Deena has 20 years of clinical research site operations experience. She joined Circuit Clinical Solution on August 2019, and is a senior strategic advisor, very impressive. [crosstalk 00:03:12]. She's actually helping with one of their products and she'll talk a little bit about that as well. What I love is also just her raw expertise. She started at Sheridan Clinical Research and helped create and develop a research program which supported an organization of over 6,500 physicians nationwide, which deployed research. Her last gig was VP of Qcare IQVIA, where she developed and operated the first SMO from the ground floor. She onboarded Qcare's first eight sites, and built the infrastructure for the business unit. She is a founding member of ACRP in Southeast Florida, she is part of WIN,