Emily A. Matejka, clinical research associate, IMARC Research On April 11, a memo was released from the Office of Management and Budget (OMB) stating that United States agencies, which include the Food and Drug Administration, rules and guidances must go to the OMB’s Office of Information and Regulatory Affairs for review beginning on May 11. […]

John Lehmann, Director of Business Development, IMARC Research Auditing brings an independent, quality assurance perspective to the clinical research landscape. Investigational sites, sponsors, and vendors benefit from high-level process assessments and improvements. Auditors leverage extensive training and experience to help ensure subject safety, data integrity, and protocol and regulatory compliance. Have you considered taking a […]

by Natalie Jarmusik, Clinical Research Associate, IMARC Research The Nuremberg Code is one of the most influential documents in the history of clinical research. Created more than 70 years ago following the notorious World War II experiments, this written document established 10 ethical principles for protecting human subjects. We’ll take a closer look at its […]

With the resignation of FDA Commissioner Scott Gottlieb taking effect this month, many clinical research professionals are wondering how this could impact their drug and device trials. During his tenure of just under two years, Dr. Gottlieb introduced a number of initiatives, including one aimed at aggressively regulating teenage vaping, reducing nicotine in cigarettes to non-addictive levels […]

John Lehmann, director of business development, IMARC Research Good Clinical Practice (GCP) is a foundation for all clinical research, driven by a desire to ensure everyone who participates in studies is given the protection they deserve. The fundamental principles of GCP have not changed since they were introduced more than 50 years ago. However, as […]

Brandy Chittester, chief of clinical operations, IMARC Globally, more than 325 million people own wearable, connected devices, and more than 2.5 billion own smartphones. Using wearable devices in clinical trials can bring huge benefits, however, there are also concerns. Here’s a look at how researchers are using wearable devices — and what you should consider […]

Sandra Maddock, president, IMARC Research The history of clinical research is filled with unfortunate examples of drug and device trials that involved serious ethical violations, injured patients or even resulted in death. It’s a sobering reminder of the many risks medical devices can pose to patients and the importance of compliance in clinical trials. Although many of […]

John Lehmann, director of business development, IMARC The history of clinical research is both fascinating and troubling. It’s a series of trial and error, followed by regulations that put patient safety ahead of profits. In fact, it’s the reason IMARC Research exists—and why we’re proud to be a partner in compliance for so many medical […]

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. […]