Toni Hegyi, Manager, Quality Assurance at IMARC Research, Inc. No matter where you land on the clinical research spectrum, chances are you have encountered some challenges with interpreting and/or implementing Good Clinical Practice (GCP) guidelines. With so many trial designs and research settings, it can be difficult to know how to appropriately apply GCP and […]
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Understanding the MDR & IVDR: What Medical Device Companies Need to Know
By Brandy Chittester, MS, CCRA, President These regulations are intended to place a greater emphasis on safety, with greater requirements for clinical evidence and increased oversight by regulatory agencies. The regulations will not allow grandfathering of previously approved products, so device manufacturers will need to re-evaluate their entire product portfolio to identify the steps needed […]
Understanding budgets, extra costs and feasibility in clinical research
Heather S. Friar, clinical research associate, IMARC Research Understanding the cost of something is important when making a financial decision both professionally and personally. It is imperative that one understands the cost of an item which includes the extra fees that may not be visible on the price tag. The same is true in conducting […]
Exploring FDA approval pathways for medical devices
Lisa Wickert, Clinical Research Associate at IMARC Research, Inc. If you missed Part One of our medical device series reviewing medical device classification, please check it out here! Now that we have a grasp of the FDA medical device classification fundamentals, we can begin to explore the various pathways that a new medical device may […]
Why data integrity is important for the success of clinical trials
Heather S. Friar, Clinical Research Associate, IMARC Research, Inc. Data integrity is a fundamental requirement of medical research and laboratory experimentation. All studies should be conducted according to the protocol guidelines and documented accurately and completely even if the data disproves or challenges the posted hypothesis. As researchers, it is our responsibility to make sure […]
How Eva Mozes Kor taught patient protection in clinical trials
Sandra Maddock, CEO of IMARC Research My motivations for going to professional conferences usually revolve around staying abreast of new information relevant to my field, networking with others, and earning CEUs. I’ve never gone to a professional conference expecting to be emotionally moved in a giant way, but that’s exactly what happened at an ACRP […]
Clinical Study Cleanup: How to Get Your Study Back on Track
By Kelly Jasko, Lead Clinical Research Associate Every year, the U.S. Food and Drug Administration (FDA) releases metrics detailing the outcomes of the Bioresearch Monitoring (BIMO) inspections done at facilities conducting clinical research within the previous year. Of the 104 Sponsor/Monitor/Contract Research Organization (CRO) inspections done in fiscal year 2017, 36 percent were found to […]
FDA regulations and guidances under review
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. […]
Taking quality GCP audit snapshots
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 […]
The Nuremberg Code and its impact on clinical research
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 […]
What a new FDA commissioner could mean for clinical research
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 […]
