Transcription
Speaker 1 0:05
Hi, everyone. My name is Erin Hagen. I'm a manager on the business development team at MCRA. I wanted to take a couple minutes to introduce MCRA just in case we can be a support of any medtech companies in the audience today. So, just a quick overview. MCRA is a global CRO, an integrated advisory firm specializing in clinical study management, US and international regulatory reimbursement, quality assurance, health care compliance, and cybersecurity consulting services. So MCRA is really goal is to support clients through each stage of the product lifecycle all the way from, you know, product planning through market access. Our team supports clients in three different areas. So countries I should say, including North America, Europe, Japan, and North America, we offer six more offer six core services, which I just mentioned. And then we have over 30 former FDA officials on our team, we are multi therapy specific and have full service CRO capabilities. In Europe, we have former notified body decision makers have supported over 300 successful CE marks and have an expansive network of clinical research associates across major geographies. And then lastly, in Japan, we have over 50 PMDA approvals and our designated marketing authorization holder, also known as a Dima. So Nico really aims to work with its clients through each stage of the product lifecycle, beginning with preclinical needs such as assessing market, identifying the reimbursement and regulatory strategies, assisting in clinical study startup and contract negotiations sites, to the clinical stage of study execution and regulatory submission, through to approval and preparing for commercialization, all the way to post approval and having discussions with payers to get put on positive coverage policies, implement patient access programs and to accelerate to accelerate adoption and to QMS audits and compliance program development as well. So we have a deep therapeutic expertise in many areas, as you can see here, but a few to highlight are orthopedics, spine anesthesia, critical care, digital health, in vitro diagnostics, cardio of cardiovascular, neurology and wound care. The reason I mentioned these particular therapies is because Mikra has hired former US FDA reviewers and branch chiefs in these specific areas. So by having these individuals on our team, we're really able to set up our clients for success because we know exactly what the agency really is looking for. In addition, we have reimbursement and clinical experts in these areas as well. So as a whole Mecca really has been serving clients for over 19 years. We have over 200 team members across all service areas we serve 700 clients annually support over 100 studies annually. We've supported over 60 PMA submissions have submitted over 100 coding and payment applications and have submitted over 75 breakthrough designation to the FDA. So I'm sharing these stats with you today just to demonstrate that the macro team is more than capable to help support your technology in various different ways. Whether it really be through clinical study management, regulatory reimbursement, quality assurance, health care, compliance, or cybersecurity support. So that's really it for today. If you're interested in meeting with the macro team. We'll be here through the end of the week. And so please reach out either our emails here info@mcro.com. Or you can reach out directly through the LSI app and we would be more than happy to connect you to our team to discuss how we can potentially support you. Thank you
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