Velocity Clinical Research

Quality isn't just a department. It's a discipline — and the numbers show it.

This year, two Velocity sites — Berlin, Germany and Savannah, GA — underwent FDA inspections, both closing with zero Form 483 observations. For context, FDA's own published data shows roughly one in four clinical investigator inspections results in a 483 being issued. Two clean inspections isn't luck. It's the output of a system.

That system runs across three dedicated teams. Quality Assurance manages controlled documents, leads internal and regulatory inspections, supports sponsor audits, and drives CAPA. Quality Systems administers our QMS, oversees company-wide training compliance, and validates new systems and processes. Quality Control applies a risk-based approach to targeted review of trial data — consent, eligibility, visit compliance, safety reporting, and source verification.

Since 2022, we've completed 156 sponsor audits — 25 in the first half of 2026 alone — plus 29 regulatory inspections. Every one is an opportunity for a sponsor or regulator to look under the hood. We welcome that scrutiny, because we build for it every day.

Findings are the industry norm. A clean record is a choice — and it takes a dedicated team of experts to make it consistently.

That's the team behind Velocity.

Wishing everyone a safe and happy Fourth of July from all of us at Velocity Clinical Research.

Today we celebrate the spirit of independence — and the people across our sites who show up every day in pursuit of something bigger: advancing medicine and improving lives for patients everywhere.

Enjoy the holiday. We'll see you back at it tomorrow.

Clinical research has no shortage of data.

What the industry needs is intelligence.

Tyler M. Beasley, Executive Director of Business Intelligence, makes that case in a newly published piece in CIOReview — and it's a distinction worth paying attention to.

In the article, Tyler explores how business intelligence is shifting from a secondary operational function to a mission-critical one, why sponsors are no longer satisfied with retrospective reporting, and what it actually takes to transform site-level data into actionable insight that improves feasibility, enrollment, and study ex*****on.

As he puts it: the future of clinical research will not be shaped by data volume, but by how effectively organizations turn that data into actions.

Read the full article here: https://www.cioreview.com/leadership-perspectives/from-data-to-decisions-the-emerging-necessity-of-business-intelligence-in-clinical-research-nid-42463-cid-192.html

Congratulations to Zydus Therapeutics on the US FDA granting Priority Review to their New Drug Application for saroglitazar for the treatment of Primary Biliary Cholangitis (PBC)!

Kris Kowdley, MD, AGAF, FAASLD, FACP, FACG, was featured in the Zydus Therapeutics announcement highlighting the Phase 3 results of the EPICS-III trial. In the study, saroglitazar met its primary endpoint, with 56.7% of patients achieving biochemical response versus 9.8% on placebo — a clinically meaningful result for patients whose disease continues to progress on ursodeoxycholic acid (UDCA).

A huge congratulations to Zydus, Dr. Kowdley and his team at our Seattle site, the global research teams, and most importantly, the patients who participated in this important study. Your contribution brings this potential new therapy one step closer to those who need it most.

Read the full press release in BioSpace: https://www.biospace.com/press-releases/zydus-therapeutics-new-drug-application-nda-for-saroglitazar-to-treat-primary-biliary-cholangitis-pbc-granted-priority-review-by-the-us-fda

Velocity is looking forward to attending the American Diabetes Association (ADA) Scientific Sessions in New Orleans, June 5–8, 2026—one of the leading global forums for advancements in diabetes research and care.

Representing Velocity onsite:
• Sarah Smiley, DO, FACP – Chief Medical Officer
• J. Scott Overcash, M.D. – Medical Director, Principal Investigator
• Stanley Hsia, MD – Principal Investigator
• Chandler Starr – Director, Business Development

Our team is eager to engage with industry leaders, share insights, and explore new opportunities to advance diabetes clinical research. If you’ll be there, we’d welcome the opportunity to connect! Set up a 30-minute block with us: https://velocityclinical.com/contact/ada-2026/