Clinical Research and Clinical Trial Support

What we do: PKCS supports sponsors and contract research organizations (CROs) running clinical trials in Iraq and the wider MENA region. We prepare and submit clinical trial applications to the Iraqi Ministry of Health, manage ethics committee submissions, secure import permits for investigational medicinal products, advise on Good Clinical Practice (GCP) compliance, and provide oversight of in-country trial conduct.

Why run clinical trials in Iraq and the MENA region?

Iraq, Egypt, and several other MENA markets offer access to large, treatment-naive patient populations for therapeutic areas where Western recruitment is increasingly difficult — oncology, infectious disease, chronic non-communicable disease, and certain rare diseases with regional prevalence patterns. Sponsors looking to broaden the geographic representativeness of pivotal trials, or to support local registration with locally-generated efficacy data, increasingly include MENA sites in their global development programs.

The trade-off is regulatory complexity: each country has its own clinical trial application, ethics framework, and import permit process, with varying degrees of harmonization with ICH-GCP. PKCS bridges that gap.

What does PKCS deliver in a clinical research engagement?

• Clinical trial application (CTA) preparation — Compilation of the regulatory dossier required by the Iraqi Ministry of Health for new trial authorizations.
• Ethics committee submissions — Submission to and management of independent ethics committees / institutional review boards in target sites.
• Investigator and site selection support — Identification of qualified investigators and trial sites in Iraq and partner MENA markets.
• Import permits for investigational medicinal products — Securing the regulatory authorizations required to import and use unlicensed investigational products in clinical trials.
• GCP advisory — Compliance gap assessments, training, and ongoing advisory aligned with ICH-GCP and country-specific overlays.
• CRO oversight and qualification — Independent oversight of contract research organizations conducting trials on the sponsor’s behalf, including site monitoring quality reviews.
• Pharmacovigilance during trial conduct — Expedited reporting of serious unexpected suspected adverse reactions (SUSARs) and integration with the sponsor’s safety database.

How does clinical research support work alongside regulatory affairs?

Clinical trial data generated in MENA is most valuable when it directly supports a future regulatory affairs submission. PKCS structures clinical engagements with the eventual marketing authorization in mind — choosing endpoints, comparators, and study designs that satisfy the local regulator’s expectations for that product class, so the same data can be used to register the product in Iraq, the UAE, and Saudi Arabia.

Related services

• Regulatory Affairs — Use trial data to support marketing authorization.
• Pharmacovigilance Services — SUSAR reporting and trial-phase safety monitoring.
• Iraq Drug Registration — Iraqi MOH approval pathway for products supported by local trial data.

Frequently asked questions

How long does a clinical trial application take in Iraq?

Iraqi MOH clinical trial application timelines vary by phase, therapeutic area, and ethics committee responsiveness. Sponsors should plan for several months from CTA submission to first-patient-in. PKCS provides realistic timelines based on the specific trial design at the kickoff.

Does Iraq follow ICH-GCP?

Iraqi clinical trial requirements broadly align with ICH-GCP, with country-specific overlays around ethics committee composition, informed consent in Arabic, and import permits for investigational medicinal products. PKCS structures studies to meet both ICH-GCP and Iraqi expectations.

Can PKCS provide investigator site networks in Iraq?

PKCS works with established investigator sites in Iraq across major therapeutic areas. Site selection depends on the specific protocol, patient population, and operational requirements; PKCS scopes site network access at the start of each engagement.