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. […]

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 […]

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 […]

Brandy Chittester, Chief of Clinical Operations, IMARC The FDA announced the availability of a new Draft Guidance Document for industry entitled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for FDA Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to FDA.”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 […]

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 […]

Lauren Luzar, clinical research associate, IMARC In Vitro Diagnostic (IVD) devices used in clinical trials are classified according to the risk that is involved based on the potential outcomes and impact if the test does not perform properly.  The risk class (Class I, II, or III) determines the review pathway for regulatory assessment. If the […]

Sandra Maddock, president and CEO, IMARC Research Thanks in large part to innovation in the medical device industry, the average human lifespan has nearly doubled in the past hundred years. Medical devices have undoubtedly improved the quality of life for millions of people, too. But a provocative new Netflix documentary raises an important question: Is […]

John Lehmann, Director of Business Development, IMARC Research Training programs should build proficiency in core job skills and be based on a strong regulatory foundation. Course curriculum should include practicum/on-the job training as well as exposure to emerging topics such as future trends in clinical data and patient centricity. As trials continue to become more […]

John Lehmann, Director of Business Development at IMARC Research In order to comply with applicable regulations and requirements, the intention of clinical trial monitoring is to protect the rights and well-being of study subjects, ensure data integrity, and ensure that the trial conduct is in compliance with the clinical investigational plan (CIP), agreements, GCP, requirements […]

Melissa Wollerman, Clinical Research Associate, IMARC Research In a previous blog published towards the end of 2013 titled “Essential Documents – What Will Regulatory Binder Look Like in 5 Years?”, the blog encompasses the potential of Regulatory Binders becoming electronic. Now, almost five years later, many sites and sponsors have explored and implemented the electronic filing […]