hybrid Protocol review
Get improved protocol accuracy, scientifically sound, GCP & spirit compliant.
resulting in shorter IRB/EC submissions, cutting down amendments, faster patient recruitment and reduced overall trial cost
By combining 25 years of human expertise in research methodology, clinical trial regulation and biostatistics, together with the accuracy, speed and consistency of AI
About Us
Transparency, integrity, and trust form the foundation of our relationships with pharma companies, startups and academic institutes. We pride ourselves on providing objective advice, staying current with regulatory authorities.
Our Team
Dr. Rafael Marilus. Specialist in internal medicine with special interest in Hemato-Oncology. Expert in research methodology. Teaching in the university of Haifa, Israel in the biannual semestrial course of advanced GCP- Protocol and CRF design. Lecturer of various EC committee members in Israel on methodology, statistical and ethical principles in the process of protocol review.
Services
We're here to ensure your journey is smooth and cost-effective.
Protocol Review Services
For more than two decades, we help sponsors and research groups reduce costs, streamline operations, and increase first-pass approval rates. Our experience covers:
Protocol design – for pharma, academic institutes and startups.
Regulatory & ethical expertise – training IRB members and lecturing on methodology, ethics, and statistical principles in protocol review.
Academic & clinical foundation – M.D., board-certified in Internal Medicine, with extensive teaching in GCP and research methodology at leading Israeli universities and hospitals.
Our company, Elmar Clinical Research Management Ltd., specializes in hybrid protocol review—where human expertise and data-driven approaches come together to reduce amendments, accelerate timelines, and improve trial outcomes.
If your organization is looking to:
Reduce protocol misalignments
Cut down costly amendments
Achieve faster ethics/regulatory approvals
We would be glad to explore how we can collaborate.
Let’s schedule a short call to discuss how these capabilities can directly benefit your upcoming projects. Please feel free to reply to this email or reach me directly at 972-50-5559480.
Academic Appointments & Teaching
Instructor at Sackler Faculty of Medicine, Tel Aviv University.
Lecturer in multiple GCP and research methodology courses for physicians, IRB members, and clinical researchers across leading Israeli medical centers (Sheba, Rambam, Kaplan, Wolfson, etc.).
Academic consultant and course director at Haifa University for advanced GCP and protocol design.
Lecturer at national and international clinical research conventions on topics including trial design, statistical methodology, oncology research, and cannabinoids in clinical trials.
Testimonials
★ ★ ★ ★
Dr. Adi Zoref Lorenz MD PHD
★ ★ ★ ★
As a principal investigator, I’ve reviewed many protocols that felt overly complicated or inconsistent. Rafael’s service stood out—he identified misalignments that even seasoned trialists might overlook, while respecting the scientific and ethical priorities of the study. Thanks to his review, our trial design became leaner, more logical, and easier for site staff to execute. It’s rare to see clinical experience and AI complement each other so effectively
Prof. Moshe Mittelman MD. Hemato-oncology
Working with Rafael’s hybrid protocol review service was a turning point for our oncology trial. His combination of deep clinical insight and AI-driven consistency checks helped us align objectives, endpoints, and assessments from the start. The result: our protocol was approved on first submission to the ethics committee, without a single amendment request.
Adi Lorenz Zoref MD. PhD
As a principal investigator, I’ve reviewed many protocols that felt overly complicated or inconsistent. Rafael’s service stood out—he identified misalignments that even seasoned trialists might overlook, while respecting the scientific and ethical priorities of the study. Thanks to his review, our trial design became leaner, more logical, and easier for site staff to execute. It’s rare to see clinical experience and AI complement each other so effectively.
Get In Touch
