Emily Zetzer, clinical research associate, IMARC Recently FDA Commissioner Scott Gottlieb released a statement on a record year for device innovation. This press release highlights the FDA’s efforts for advancement of medical devices that serve previously unmet medical need, improve quality of life, and in some cases save lives. The FDA’s efforts to continue the […]

Sandra Maddock, President & CEO, IMARC Research Imagine being enrolled in a clinical trial without fully understanding the scope or the risks. The Belmont Report marks an important milestone in the history of clinical research. It established guidelines for basic ethical principles, as well as informed consent, the assessment of risks and benefits and subject selection. […]

Sandra Maddock, President & CEO of IMARC Research With new technology and groundbreaking medical device news making headlines every day, there has never been a more exciting time to be involved in clinical research. So much is changing so fast — faster than at any other time in the history of clinical research. At IMARC Research, […]

Rachel Martukovich, Clinical Research Associate for IMARC Research, Inc. The recent partial government shutdown, which is now the longest in US history, has various stakeholders in the medical device and pharmaceutical industries concerned with the potential impact on the world of clinical research.  The FDA is one of the federal agencies most affected, as the […]

Rachel Martukovich, clinical research associate, IMARC Research Recently the FDA released an announcement outlining plans to further modernize the 510(k) clearance pathway. This briefing falls in line with the latest efforts by the FDA to promote and improve safety and effectiveness in an efficient manner. The current 510(k) framework, which has been in existence since […]

John Lehmann, director of business development, IMARC Research At IMARC, we pride ourselves on being trusted advisors. It’s our greatest privilege to support clinical research sponsors and help them earn approval to bring their devices to market. That’s why we’re eager to share so many resources with you. This year, our most popular resources included a checklist […]

Ashton Steinhagen, lead clinical research associate for IMARC Research, Inc. The FDA released a follow-up statement to their “Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health” release that was unveiled in April 2018.  The focus was expanding on post-market surveillance for medical devices. In this plan, the main objectives were to promote and […]

John Lehmann, Director of Business Development, IMARC Research When it comes to ensuring compliance, keeping your trial on track and bringing your medical device to market faster, having independent oversight from a strategic partner makes all the difference. Because device trials bring unique compliance challenges, working with a contract research organization with specific expertise in […]

John Lehmann, director of business development, IMARC Clinical project management is a logical and often desirable1 career progression for those in CRA roles. While the exact path from CRA to project manager (PM) varies from company to company and person to person, the first step for the budding PM usually involves education. For most, this […]

Sandra Maddock, President and CEO, IMARC Research Entering the “home stretch” of a medical device trial is always an exciting time. You can see the finish line in sight. You’ve planned for success, and you’ve run the race well. But before you take your victory lap, you still have a few more hurdles to clear. […]