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COVID-19 global pandemic. PRN is virtual-certified through its partnership with VirTrial and plans to expand use of the technology with the looming health crisis. "We are seeing many obstacles taken down in the area of telemedicine in an attempt to keep communication of the virus down," Bain says. For Ba i n, it 's more t ha n a busi ness; it 's a m ission to advance medicine. "We want to help people," Bain says. "We want to make the trial process more accessible so physicians can expand their practices. We want to give the patients more treatment options. We want to help medicine move forward." And partnering with incubators like MedtoMarket is key to that. "They're very forward-thinking and they're trying to solve a problem in the industry. It's all about innovation," she says. "They are providing a launchpad for biotechs and standardized training to make everything more efficient and, in the long run, drive down the cost of drugs and the cost of health care." In MedtoMarket, PRN found another partner looking to improve upon the traditiona l we've-a lways-done-it-that- way thinking. "We've decided to team up with Clinical Research Fastrack in an effort to staff our sites with highly trained personnel," Bain says. "Their training program is one of the most comprehensive out there, providing both in-class and field training from industry experts. It's bringing standards to our industry." ANSWERING QUESTIONS BETTER AND FASTER Lauren Ballina Chang, National Program Director for Clinical Research Fastrack, thinks she knows the reason there are shortages of trained clinical researchers. "No one grows up thinking, 'I want to be a clinical researcher.'" she says. "In fact, that isn't even something most people know is a career option." Clinical Research Fastrack is designed to address that. From their headquarters in Arizona, they train aspiring clinica l research professionals, physicians and other study staff who want to bring new devices, drugs, and therapies to market. "I think a lot of people get into medicine because they want to help people. Well, clinical research is always working on the future of medicine," Chang says. "They get to work on cutting- edge new devices or therapies or medications, as well as offer new options to their patients. If the goal is to help people, I can't think of a better way to reach well beyond just one patient at a time." Mario Sierra, business strategist with PRN and a graduate of the Clinical Research Fastrack training program, is a prime example of what is possible with this new training methodology. "I had a good educational background for research, but no practical experience to land me a job in the industry. Fastrack solved that problem for me and put me in front of people who were looking for quality candidates," Sierra says. "I capitalized on the opportunity and was fortunate enough to have a job lined up before training was even over. That's the power of Clinical Research Fastrack." Ultimately, clinical research is trying to find the answer to such questions as, "Is this new intervention safe?" "Is it effective?" When questions like these are answered, the entire medical community greatly benefits. Conducting clinical trials is a way for physicians to generate more revenue for their practices while staying at the forefront of their field of medicine. However, if you haven't had training in clinical research, it can be difficult to get your very first trial. "Clinical research is like its own specialty. You couldn't be a practicing surgeon without the proper residency and, just the same, you can't be a practicing principal investigator without the proper training," Chang says. "Physicians have extensive medical knowledge and expertise but lack the understanding of clinical research operations. Clinical Research Fastrack is able to fill this gap so that all parties involved are able to oversee trials successfully." Chang notes that one of the key issues with trials is noncom- pliance with the FDA's regulations regarding the Statement of Investigator Form 1572, a binding agreement between the investigator and the FDA. As she sees it, "a lot of it goes back to a lack of training, inadequate training or just not the right training. It's not that it is difficult, it's just that you don't know what you don't know, and that's where mistakes happen, delays happen, trials are lost and subjects are put at risk." The 1572 regulations are in place to ensure that all protocols are adhered to and the investigators or clinicians are qualified and that the results delivered to the sponsor are accurate and that FDA rules are followed, protecting the safety and well-being of participants and collecting clean, credible data. There's an extensive amount of paperwork and protocol to follow. The physician oversees this, but much of it is delegated to other study staff. This is where a company like PRN comes in — to take care of the day-to-day, nitty-gritty details of running the trials, Chang says. A traditional clinical training program can take up to two years to complete, valuable time that is has been seen as the industry standard. Clinical Research Fastrack is disrupting the norm with its crash-course training methodology. From left to right: Jamaica Cundiff, Associate Program Director with Fastrack; David Silberman, Co-Founder and CEO of Fastrack; Lauren Ballina Chang, MS, CCRP, National Program Director with Fastrack 0 8❱❱❱❱❱ C O V E R S T O R Y

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