Publications
Insurance Considerations for Global Clinical Trials
Excerpted from the Journal for Clinical Studies, September 2009. As the number of trials being conducted in multiple countries continues to increase, sponsors must insure themselves against...
The Biomaterials Access Assurance Act
Abstract: A life sciences broker recently contacted Medmarc regarding a company that was interested in expanding into the medical device supply market. The company was under the mistaken...
The Ethical Oversight of Clinical Trials: Institutional Review Boards
Abstract: Clinical trials—medical research studies involving people—play an essential role in the advancement of medical science and technology. The information obtained from clinical...
Document Management: How Life Sciences Technology Companies Can Protect Themselves
Product Liability is a Significant Risk to Life Sciences Technology Companies While some product liability lawsuits grab media attention, 90% are settled out of court through agreements...
Clinical Trial Insurance: Comparing the Coverage Alternatives
Most buyers of clinical trial insurance look for broad coverage at an affordable, predictable cost. The difference in coverage offered by insurance companies can be confusing and the...
The Basics of Contractual Risk Transfer
In an age of outsourcing, before a finished medical device or pharmaceutical product reaches its end user, it will be "touched," literally and figuratively, by multiple vendors, such as...
Why Distributors May Be More Vulnerable to Products Liability
Introduction Although most medical device companies today are likely aware of the increasing threat of products liability lawsuits, the risk may not be as obvious to product distributors....
Best Practices for Responding to Form-483s and Warning Letters
Perhaps no enforcement actions are dreaded more by life science companies than FDA Form-483s and Warning Letters. This is not only because these actions put the company on the FDA’s radar...
Human Tissue Products
Products or product components that are composed of human cells and tissues, such as stem cells, are at the forefront of medical technology. They may also receive unique treatment under...
Minimizing Risk When Obtaining Informed Consent
Compliance with FDA regulations is only the first step in minimizing the risk associated with the informed consent process. This article provides an overview of requirements and several...