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.
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 […]
Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
This post is sponsored by IMARC Research, Inc. When a Sponsor-Investigator conducts a device study, it may be referred to as a Physician-Sponsored IDE (PS-IDE). Chaos can sometimes ensue when one begins down the path of a PS-IDE. This white paper will attempt to make sense of that chaos by providing a brief overview of […]
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.
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 […]
Selecting outstanding sites is the key in running a well-controlled clinical trial. Failure to identify outstanding sites could result in added costs and could lead to delays in bringing much needed products to the bedside.
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.
This post is sponsored by IMARC Research, Inc. Per federal regulations, 100 percent of investigative products must be accounted for at all times so they are not used for an incorrect indication, in an incorrect way, or by someone who has not been properly trained in its use. Taking steps to ensure proper accounting can […]
This post is sponsored by IMARC Research, Inc. For all clinical trials, operating in compliance with the federal regulations, the agreements, the investigational plan, and the requirements of the IRB is critical to protect human subjects and to demonstrate quality and integrity of the resulting data. When imaging is introduced into a clinical research trial, […]
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 […]
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
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 […]
This post is sponsored by IMARC Research, Inc. Compliance with the Federal Regulations, Agreements with the Sponsor, Investigational Plan, and Requirements of the IRB play a vital role in the FDA approval process. Effective training of the study team is a key component to a site’s overall success and compliance. No matter the “sport” (device […]
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 […]
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 […]
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 […]
