IMARC Research, Inc.

Posts by IMARC Research, Inc.

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Download our eBook: The History of Clinical Research

For clinical research professionals, the protection of human subjects has always been of paramount importance. Doing so while ensuring accurate and credible data are obtained are the primary roles for every individual on a research team. Unfortunately, history reminds us that unethical research practices and/or disregard for the well-being of human subjects has not only occurred in the past, but continues to do so today.

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New infographic: Risk-Based Monitoring Checklist

This post is sponsored by IMARC Research, Inc. In a recent blog post, we provided an overview of the “Guidance for Industry: Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring” that the FDA released this past August. Risk-based monitoring continues to remain a hot topic as the industry navigates its comfort level with […]

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Exclusive training will teach the FDA approval process for cardiovascular clinical trials

IMARC and CardioMed have partnered to offer an exclusive training specifically geared to explain the FDA approval process for cardiovascular clinical trials. Drawing on expert speakers from the cardiovascular device industry and formerly of the FDA, this intermediate-level training program will guide attendees through the process of going from product idea through clinical development and approval.

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Cell therapy: the fourth pillar of healthcare

This post is sponsored by IMARC Research, Inc. As the cell therapy market continues to grow, it’s important to note the similarities between medical device and cell therapy clinical trials. To help illustrate this, we’ve created an infographic, “Cell Therapy: The Fourth Pillar of Healthcare,” which is available for download. Currently three main pillars of […]

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Auditing versus Monitoring: What’s the difference?

In the realm of clinical research, two functions often work together to complement each other to create an additive impact on the overall quality and integrity of a clinical trial. The two functions are clinical monitoring and auditing. But how do these work hand-in-hand, and how are they different? Many professionals working in the clinical research arena may not appreciate or understand the roles and differences between clinical research auditing and monitoring, two distinctly different functions. Or if they do, they may not understand that the two functions can have an additive rather than redundant impact on quality.

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Clinical Trial Regulation Revelations

This post is sponsored by IMARC Research, Inc. The regulations surrounding clinical trials can be difficult to understand and interpret, even for monitors well-versed in the parts of the Code of Federal Regulations (CFR) Title 21 that relate to clinical research. When a monitor has a tiny epiphany while working through a difficult compliance issue […]

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IRB… As easy as 123!

This post is sponsored by IMARC Research, Inc. The key players in a clinical investigation are infamously made up of Sponsors, monitors, investigative sites, and patients.  A fundamental part of the team is also the Institutional Review Board (IRB), as they oversee the conduct of clinical research. Per the FDA’s IRB information sheet, “IRBs are […]

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The best way to document your clinical research

This post is sponsored by IMARC Research, Inc. Without a good working knowledge of Good Documentation Practices in clinical research, unintended consequences may occur.  When it comes time for an inspection, it may be difficult to prove that the research process was being conducted properly without strong source documentation.  This may manifest itself in illegible […]

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Risk-based monitoring: Do I still need to go onsite?

This post is sponsored by IMARC Research, Inc. Since the August 2011 release of the draft guidance document by the FDA on a risk-based approach to monitoring, there has been a lot of buzz in the industry about how to apply the approach in clinical trials. While many ask the question about how this risk-based […]

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The top 5 complications of FDA medical device trials

This post is sponsored by IMARC Research, Inc. “You do a really good job with complex trials.” We’re lucky to say that we’ve heard this from several clients over the years. But, while we’re glad for the recognition, it made us ask ourselves a key question. What is it that makes a trial complex? For […]