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 […]
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Transforming the 510(k) program
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 […]
The most popular clinical research resources from 2018
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 […]
Enhancing post-market safety
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 […]
5 keys to choosing a medical device CRO
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 […]
Clinical trial project management in practice
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 […]
Ensuring compliance after a medical device trial
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. […]
What does Brexit mean for clinical research?
Melissa Wollerman, clinical research associate, IMARC Research As Brexit negotiations continue between the UK and EU, clinical research sponsors are carefully considering the future of research in the UK, as the number of clinical trials held there has begun to decrease. From an average of 806 trials a year conducted between 2009 and 2016, to […]
How to ensure compliance before your medical device trial begins
By Sandra Maddock, IMARC The only way to gain the FDA approval you need to bring your medical device to market is to ensure compliance at every stage in the clinical trial lifecycle. That starts long before you sign up your first subject. The planning stage is crucial because it sets expectations for how your […]
FDA releases draft guidance document on civil money penalties
Brandy Chittester, Chief of Clinical Operations, IMARC The FDA announced the availability of a new Draft Guidance Document for industry entitled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for FDA Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to FDA.” The basis for the document is to provide FDA’s […]
Don’t make these mistakes in your clinical trial: The most common FDA violations
John Lehmann, Director of Business Development, IMARC The FDA’s Bioresearch Monitoring (BIMO) inspection program ensures the protection of the rights, safety and welfare of human subjects during clinical research trials. The most recent results represent findings from more than 1,300 clinical research audits of clinical investigators, sponsors and IRBs for the 2017 fiscal year. This […]