About Us
We’re not just a research site – we’re a Community-driven mission for better medicine.
Physician Led Research, Patient First Results
We are a physician‑owned clinical research organization dedicated to delivering fast, reliable, and ethically sound trials that bring tomorrow’s therapies to patients today. Our investigators and staff combine world‑class medical credentials with a culture of rigorous quality management, ensuring every study meets—and often exceeds—FDA, ICH‑GCP, and 21 CFR Part 11 standards.
Who We Are
- Physician‑led from top to bottom—clinical decisions never leave medical hands.
- Board certified MDs
- 24/7 PI oversight & availability—triple‑board‑certified Dr. Ahmad Aswad, MD (Critical Care • Nephrology • Internal Medicine) and Dr. Gonzalez Rojas personally review eligibility, SAEs, and data queries every day.
- Staff educated, tested, and trusted—mandatory monthly GCP refreshers, protocol simulations, and annual credential audits keep every coordinator audit‑ready.
- 100 % eSource workflow—real‑time, paper‑free capture prevents ALCOA violations and supports remote monitoring.
What Sets Us Apart
- Triple‑board‑certified leadership – Dr. Ahmad Aswad pairs deep therapeutic insight with a proven regulatory track record, guiding protocol execution and FDA discussions from day one.
- Flawless FDA performance – Dr. Gonzalez Rojas led two inspections (2019 & 2024) with No Action Indicated .
- Immediate SAE reporting & robust internal audits – All serious events filed within mandated timelines; quarterly audits pre‑empt external findings.
- Stringent inclusion/exclusion review – Dedicated auditor→ PI checkpoints verify eligibility; complex cases escalate to academic KOLs or sponsor medical monitors.
- 98 completed trials, no safety holds
How It Benefits You
- Accelerated start‑up, fewer protocol deviations, smoother FDA reviews.
- Sponsors gain confidence that data integrity and subject safety withstand agency scrutiny.
- Faster query resolution, lower monitoring costs, audit‑ready files at all times.
- Enhanced participant protection and reduced post‑market liability.
- Enhanced participant protection and reduced post‑market liability.
- Demonstrated excellence across Phase I–IV programs.
Integrated Patient & Family Support
Beyond data, we prioritize the well‑being of the people who make research possible. Our on‑site Counseling Service offers evidence‑based education and emotional support for participants and caregivers facing dementia, depression, obesity, and diabetes. This holistic model improves retention, adherence, and—most importantly—lives.
What This Means for Your Study
- PI Eyes on Every Chart – From screening to lock, our PIs personally verify critical data points and sign off on each adverse event.
- Educated, Empowered Staff – Coordinators log > 40 hours of continuing education yearly, ensuring protocol mastery and proactive risk mitigation.
- Always Available – Our PI hotline responds within 30 minutes—day or night.
- Audit‑Ready, All the Time – Internal QA conducts mock inspections quarterly, so your trial is inspection‑ready on demand.
Ready to Accelerate Your Trial?
Contact us at draswad@optimusU.com or call +1 (305) 600 3000. Let’s bring life‑changing therapies to patients—together!
The FDA continues to emphasize real‑time documentation and PI presence.
Our FDA Inspection Record
In May 2024 the U.S. Food & Drug Administration conducted a five‑day Bioresearch Monitoring (BIMO) inspection of our clinical‑investigator site. The inspection—led by CAPT A.P.B. and LT C.A.A.—covered informed‑consent practices, subject safety, IRB correspondence, investigational‑product control, Part 11‑compliant eSource systems, and ClinicalTrials.gov compliance.
Outcome: No Action Indicated (NAI) — the FDA issued no observations. This mirrors our previous NAI inspection in February 2019, underscoring our continuous commitment to GCP and patient safety.
Need assurance of audit‑ready execution for your next study? Contact our Quality & Compliance team to discuss how we maintain inspection‑ready operations 365 days a year.
regulatory@optimusu.com
