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Full-Service Contract Research Organization

Clinical Research for Biotech and Pharma Sponsors

We plan, run and report clinical trials. Our physician- and pharmacist-led team handles regulatory, clinical operations, safety, data and quality, for a full program or only the parts you need.

  • Phase I to IV
  • All Indications
  • Global
  • CAR-T Experience

Stages We Support

Clinical development pathway supported by Roya, from strategy and feasibility through Phase I to IV.
  1. StrategyPlanning and Feasibility
  2. IND / CTASubmissions
  3. Phase IFirst-in-Human & Early Safety
  4. Phase IIProof of Concept & Dose Optimization
  5. Phase IIIPivotal & Confirmatory Trials
  6. ApprovalMarketing Application
  7. Phase IVPost-Marketing & Real-World Evidence

Who Runs Your Study

Senior physicians and pharmacists lead every study and stay with it to the final report. That means fewer handoffs and faster decisions.

Leadership Experience in Clinical Research
25+ years
Project Leadership and Medical Oversight
Physician- and Pharmacist‑Led
All Indications, Global
Phase I–IV

Regulators and Standards We Work With

  • FDA
  • EMA / CTIS
  • MHRA
  • Health Canada
  • SFDA
  • ANMAT
  • TİTCK
  • ICH E6(R3)
  • ICH E3
  • ICH Q9
  • 21 CFR Part 11
  • EU Annex 11
  • GAMP 5
  • CDISC SDTM / ADaM
  • MedDRA
  • WHODrug
  • eCTD
  • ALCOA+

Services

Hire us for a full program or a single function.
All 15 Services

Cell and Gene Therapy

Hands-On CAR-T Experience

Our team has worked on autologous CAR-T trials, where each patient's cells go from apheresis to manufacturing and back on a tight schedule. We qualify sites and couriers, run mock shipments, protect chain of identity and custody, and set up long-term follow-up.

CAR-T trials from early phase to Phase II in:

  • United States
  • Europe
  • Middle East (including Saudi Arabia)
  • Turkey
  • Latin America
Cell and Gene Therapy Services

Vein-to-Vein Steps We Coordinate

Vein-to-vein: Apheresis site qualification, then Courier qualification and cold chain, then Manufacturing slot coordination, then Vein-to-vein scheduling, then Treatment site and CRS/ICANS oversight, then 15-year long-term follow-up. Chain of identity and chain of custody throughout.
  1. 1Apheresis Site Qualification
  2. 2Courier Qualification and Cold Chain
  3. 3Manufacturing Slot Coordination
  4. 4Vein-to-Vein Scheduling
  5. 5Treatment Site and CRS/ICANS Oversight
  6. 615-Year Long-Term Follow-Up

Why Work with Roya

  • One Team for the Whole Program

    Regulatory, clinical, safety, data and quality in one team.

  • All Therapeutic Areas

    Any indication, with the most depth in cell and gene therapy.

  • CAR-T Experience

    Hands-on work on autologous CAR-T programs.

  • Ready for Inspection

    Our quality system is built on GCP, ICH E6(R3), U.S. federal regulations (21 CFR) and applicable international regulatory requirements from the start of each study.

  • Global Reach

    Feasibility, start-up and delivery across the US, Europe, the Middle East, Latin America and beyond.

Leadership

You work directly with our senior people.
Portrait of Nourein Darrag

Nourein Darrag

Co-Founder & Chief Executive Officer

Nourein Darrag co-founded Roya Clinical Solutions LLC and is its Chief Executive Officer. She has more than ten years of experience in clinical research, global clinical operations and strategic project management.

Full Bio: Nourein Darrag

Dr. Ola Soliman

Co-Founder & Chief Operating Officer

Dr. Ola Soliman co-founded Roya Clinical Solutions LLC and is its Chief Operating Officer. She has more than 25 years of experience in clinical research, global clinical operations, regulatory affairs, quality assurance and strategic oversight of clinical development programs.

Full Bio: Dr. Ola Soliman

Let’s Advance Your Clinical Development Program

Planning a new trial, expanding an ongoing study or looking for specialized support? Talk to our leadership team about your goals.

Contact

info@royaclinical.com (689) 588-6006

1650 Sand Lake Rd, Suite 201, Orlando, FL 32809

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