Clinical research requires careful attention to risk in every aspect. We’re all familiar with terms such as “Significant Risk Device,” “risks outweigh the benefits,” and “benefit-risk,” especially as risk relates to patients. This is important of course, but what about risks at the study site level? Risks to your study? Do you have a plan in place to identify, control, and mitigate risk?
A well-written Clinical Risk Management Plan can help you achieve your study goals and help you sleep at night. It might also allow you to expand your list of potential investigators to include inexperienced but enthusiastic investigators. With a proactive plan in place, you can be sure to identify issues and quickly mitigate them.
What is Clinical Risk Management?
Clinical Risk Management helps you identify, assess, plan for, and control risks at the subject, site, and study levels. It acknowledges that risk happens, and helps you take measures to make sure you’re completely prepared for it. A risk management plan ensures the risks are considered from the beginning and throughout the study, makes proactive action part of strategic planning, increases the probability of reaching objectives, and reduces the probability of poor results.
If you would like to learn more about how clinical risk management planning can help you achieve your study objectives, Bannick LLC is your experienced Clinical partner. Our Clinical Quality Services are tailored to help you achieve your goals. Contact us to learn more.