ABRS Solutions

New is the year, new are the hopes, new are the resolutions, and new are our best wishes for you!

Why is this important?
* Inadequate clinical study oversight could result in critical GCP inspection findings & delay Health Authority approvals
* ICH E6 5.2.1 "A sponsor may transfer any or all of the sponsor's trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor…"
* ICH E6 5.2.2 "The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor's contracted CRO(s)." - NEW
* FDA Guidance, " 'Although sponsors can transfer responsibilities for monitoring to a CRO(s), they retain responsibility for oversight of the work completed by the CRO(s) that assume this responsibility."
 
Let ABRS equip you with the proper tools to ensure watchful and responsible Study Oversight of your Clinical Trials!

Diversity Plans to Improve the Enrollment of Underrepresented Participants in Clinical Trials

In April 2022, the FDA made available a 12-page draft guidance document that provides information representing the FDA's suggestions and recommendations for sponsors seeking to improve the enrollment of participants from underrepresented racial and ethnic populations into clinical trials. While the industry has made significant strides on this issue, there is still a long way to go. At ABRS, we offer expertise to support and guide Sponsors to ensure diversified trials that better serve our communities.

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Every year, over 17 million people die from heart disease. Fortunately, the leading causes of cardiovascular disease are modifiable factors, which include lack of exercise, smoking, and a poor diet.

So how should you observe World Heart Day?

* Designate the day for a checkup.
You may even be able to find a World Heart Day event near you that's offering health check services. It doesn't get much easier than that!

* Get your heart rate up with fitness events!
Maintaining a healthy weight and low Body Mass Index (BMI) can help decrease your chances of developing heart disease. Whether you attend a gym or fitness class or prefer to get involved at a World Heart Day event try to make being active a priority.

* Schedule life-changing seminars.
Most cardiac emergencies occur near someone who could potentially help so setting up a CPR class and learning how to resuscitate a person could save lives. Cooking demonstrations, health lectures, and fitness lessons are great events to plan for World Heart Day.

This year's World Heart Day theme is "Use Your Heart for Every Heart." So let's do just that by spreading ways we can help prevent CVD.

Happy World Heart Day from ABRS!

To help assure continued safety and effectiveness, the FDA may require a Post-Approval Study (PAS). It's important to remember that a Sponsor's failure to comply with any post-approval requirements may be grounds for the FDA to withdraw approval. So, because of this, we need to remind ourselves that Post-Approval Studies are conditions for device approval and must be handled with the same attention and care as any other clinical trial.

At ABRS, we understand the importance of PAS trials and we love reminding folks how important they are.

To learn more about PAS trails, visit
https://www.fda.gov/medical-devices/postmarket-requireme
nts-devices/post-approval-studies-program

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