In this interview, I had the opportunity to speak with Ahmed Hamouda.

Ahmed is the Head of Clinical Operations at RAY-CRO in Egypt and a certified clinical research professional with more than 10 years of experience within the clinical research field.

I’ve been intrigued and fascinated by the Middle East and have wondered how trials are conducted in the region.

If you’ve been site and country selection meetings trying to determine whether you want to conduct trials in Egypt but have more questions than answers, this interview is for you.

You’ll hear Ahmed breakdown the exact clinical trial conduct process in Egypt step-by-step.

Ahmed has worked in a wide variety of professional capacities over different regions and markets in the Middle East, Gulf, Europe, and Asia.

He is a pharmacist by education and received his MBA in 2013. Aside from being a clinical research professional, Ahmed likes to dive and explore new cultures.

Show Notes:

Ahmed Hamouda on LinkedIn

Ahmed’s background and experience working in the Middle East
Value of conducting trials in the Middle East
- A large population of over 300 million people
- 21 countries in the region
- Prevalence of diseases such as cardiovascular and hypertension
Reasons why some Sponsors and CROs are not doing research in Egypt
- Lack of awareness of Egypt’s capabilities
- Long approval times for exporting blood samples
Importation process for medical products in Egypt
- Certificate of Analysis and quality documents
Site Start-up Process
- Select sites
- Secure IRB approval (~1 month)
- Ministry of Health Approval i.e. MoH (~2 months)
- - Observational trials can start right away
  - Interventional trials require additional review (see below)
- Interventional trials (~2 months)
- - Biological are submitted to The National Organization for Research and Control of Biologicals (NORCB)
  - Non-biological are submitted to The National Organization for Drug Control and Research (NODCAR)
- Importing investigational medical product (IMP)
- Central Administration of Pharmaceutical Affairs (CAPA)
Role of MoH vs. NORCB/ NORDCAR
- MoH will review study-specific documents such as protocol, eCRFs, CVS, patient-facing materials, insurance, patient diaries, signed contracts, etc.
- NORCD/ NODCAR will review information specific to the investigational product
Process for adding more sites midway through the study
Trial classification in Egypt - Phase I, II, III
IRB rejections (decline) and how they are managed
Product approval and commercialization
- The concept around open-box vs. close box
- Pricing file is the limiting factor
- Naming list
- Pharmacovigilance (PV) files
Contracts and Budgets
- Required at the time of IRB and/or MoH submission
- Exceptions are handled via Sponsor/ CRO generated commitment letters
Clinical Trial Research Units in Egypt
Allocation of budget and distribution between the site and the investigator
Use of clinical trial contract templates
Contracts are in English and Arabic
High-quality translations are achieved with the help of medically trained and certified translation company
Site selection process
Lack of computerized system at the site can cause issues
Career advancement for clinical research professionals in Egypt
Social responsibility on part of CRO

Other Resources:

RAY CRO
Pharma Med, a medical translation company
ICH GCP Guidelines

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