Are You Aware
of the Omnibus Reform Act requirements that must be met by the end of 2023?
Developing Inclusive Diversity Plans:
It's mandatory to create and execute comprehensive diversity plans for all device studies and phase III drug trials. This is essential to prevent legal issues and delays in trial approvals.
Establishing Systems for Diversity Metrics Reporting:
Robust data collection and reporting systems must be established to ensure accurate and timely reporting, preventing penalties, reputational damage, and loss of public trust.
Adjusting to Remote Regulatory Inspections:
Processes and systems must be updated to facilitate remote inspections while ensuring safety and quality standards. This is crucial to prevent delays in approvals and potential legal actions.
Enhancing Data Validation and Monitoring:
Site selection processes must be enhanced, and meticulous attention to detail is required to prevent legal actions, fines, and delays in trial approvals.
Adapting to Digital Clinical Trials (DCTs):
Staying informed about the recommendations and adapting processes accordingly is essential to ensure compliance and avoid legal actions and delays in trial approvals.
Don't Worry, We've Got You Covered.
We understand that you have enough on your plate and don't have room for another emergency. At Reveles, we can step up and seamlessly set you up for game-changing success in 2024.
Act Now! Don't wait until it's too late. Secure your organization's future by downloading our detailed checklist on the Omnibus Reform Act and its implications, including our services, or schedule a consultation with our experts to guarantee your organization's readiness for these pivotal changes.