DALLAS, July 1, 2024 /PRNewswire/ -- TOTAL Diversity Clinical Trial Management (TDCTM)
With the release of the FDA draft guidance on June 26, 2024 the clock starts running on enacting the Food and Drug Omnibus Reform Act (FDORA). The legislation will be enacted 180 days after final guidance is released. This is another step in the process towards the mandate for Diversity Action Plan (DAP) for all Phase 3 and pivotal studies. Do you have a plan to incorporate DAPs in your drug and device development? The experts at TOTAL Diversity are at the ready to help develop these plans.
Specifics on the draft guidance:
"Participants in clinical trials should be representative of the patients who will use the medical products," said FDA Commissioner Robert M Califf, M.D. "The agency's draft guidance is an important step?and one of many ongoing efforts?to address the participation of underrepresented populations in clinical trials to help improve the data we have about patients who will use the medical products if approved."
This is the premise that has driven TOTAL Diversity's focus around diversity planning and integration for a decade. TOTAL Diversity is the only CRO built with hitting diversity targets as a primary outcome. TOTAL's team of experts helps clients to meet enrollment targets in all populations and is ready to execute on your behalf.
The TOTAL team has experience developing detailed DAPs for oncology, expansive and rare diseases. We have experience handling FDA responses to DAPs. We have experience designing and executing the community engagement efforts essential to getting the goals of the DAPs accomplished. Our results have exceeded diversity targets and we can do the same for you.
About TOTAL Diversity Clinical Trial Management, Dallas, TX
TOTAL Diversity Clinical Trial Management is a full-service Contract Research Organization with an integrated focus on support services highlighting diversity and inclusion in clinical trials. Service offerings directed at diversity include consulting, training programs, patient recruitment, retention services and more. The growing network of diverse capable sites includes experienced diversity-oriented researchers as well as those who have access to diverse populations.
CONTACT:
Dyan Bryson
VP, Diversity Services
TOTAL Diversity Clinical Trial Management
201-803-0301
[email protected]
www.totaldiversity.com
SOURCE TOTAL Diversity
These press releases may also interest you
|