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, a new layer of complexity is added, and additional considerations with regard to helping sites maintain compliance with the imaging requirements should be implemented.
IMARC Research is committed to being an industry thought leader on a wide range of clinical research topics and recently joined forces with ImageIQ to offer a free webinar on “Imaging in Clinical Trials- Unique Compliance Challenges” with the goal of understanding:
What types of challenges can occur when you introduce imaging to the trial?
- Increase complexity of the protocol
- Additional stakeholders in the imaging process
- New technology environment
How can you manage compliance changes and invoke change dynamics?
- Know what non-compliance looks like
- The results of not following the specifics of the protocol
- Managing personnel and equipment changes during a trial
A Deep-dive Into Specialty Pharma
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.
What are the best practices to ensure compliance?
- How to write a protocol to maintain compliance
- Techniques for monitoring onsite compliance
- Approaches to take when you are out of compliance
In clinical research, having a well-run, compliant study is a top priority. It’s important to be experts in all aspects of your study. If your trial involves imaging, understanding how to get the most out of your data is not only smart — it’s cost effective.
We hope you find this webinar informative and useful. If you have any follow-up questions you would like to ask, we encourage you to post a comment below and we are happy to follow up!
