Regenerative Outcomes, LLC, an emerging global provider of outsourced regulatory and drug development support services for the Regenerative Medicine industry, announced its agreement to provide comprehensive Clinical Trial Management services to small Biotech companies in support of their FDA clinical trials.
NASHVILLE, TENN., March 12, 2021 — Regenerative Outcomes, LLC, an emerging global provider of outsourced regulatory and drug development support services for the Regenerative Medicine industry, announced its agreement to provide comprehensive Clinical Trial Management services to small Biotech companies in support of their FDA clinical trials.
Several products being submitted under IND are now underway for further advancement by Regenerative Outcomes’ efforts, one of which involves evaluating the safety for use of stem cells in the treatment of a major symptom caused by Parkinson’s Disease. Other pipeline products include targeting COVID-19 related cardiac and pulmonary diseases, as well as debilitating dermatological conditions.
“Our model has allowed us to overcome many challenges forced on the industry by the COVID-19 pandemic, and we have been able to resource, coordinate and bring to bear the planning needed to apply, obtain approval for, launch, and now manage this and other life-saving trials,” explains Doug Oliver, Founder and President of Regenerative Outcomes. “In the case of the Parkinson’s Disease focus, this enabled our client to meet their original goal of treatment for its first trial participant at the end of 2020.”
The efficiencies created by a resourcing and collaboration model are significant, described by clients as helping them cost-effectively gain IND approval and post-IND start-up, even in the midst of the pandemic.
The recent client success story of this exciting new Trial Management Support services offering has been quoted: “crucial to the proper support of our study… without compromising safety, quality, or integrity”.
ABOUT REGENERATIVE OUTCOMES
Regenerative Outcomes is comprised of a global regenerative medicine team possessing specialized subject matter expertise, FDA insight and scientific acumen.
The company uses a full spectrum approach to meet both the strategic and practical resourcing gaps common to its biotechnology clients, while highlighting skills and foresight needed to optimize their positioning and preparedness for approval of healing technologies in the regenerative medicine space.
In addition to its Clinical Trial Management service offerings, Regenerative Outcomes provides “bench-to-bedside” turn-key regulatory consulting, from initial indication research through to assisting with early stage trials.
Its innovative Program for Analytics and Compliance Education (“PACE”) for point-of-care practitioners uses data-driven heuristics to identify and address non-compliant promotional messaging, and uses that data to help providers guide their practices toward FDA compliance.