Publications
Clinical Trials
Risk Management 360: Risk Management in Clinical Trials
In their years working with life sciences companies – large and small – Medmarc’s risk managers have evaluated numerous medical devices and pharmaceuticals as well as their manufacturing and...
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...
IMDA: Together We're Better
Being the owner of a small, entrepreneurial company can be exhilarating. You write your own ticket, set your own direction. But it can also be daunting. After all, there are no corporate coffers...
Employee Participants In Clinical Trials
Using employees as participants in a clinical trial is one solution for keeping trials on schedule. However, their participation and recruitment is fraught with the potential for inappropriate...
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...
FDA Requirements for Informed Consent Forms
Obtaining informed consent from participants in a clinical trial study is vital. A key document in the informed consent process is the informed consent form. Food and Drug Administration...
Drafting Informed Consent Forms | Medmarc
The key objective of obtaining informed consent from a clinical trial participant is to ensure that the participant fully understands the nature and risks of the clinical trial. The informed...
International Clinical Trials: Look Before You Leap
Logistical problems and financial pressures prompt many medical technology and life sciences companies to sponsor human clinical trials outside the borders of the United States. As...