About IQVIA Pakistan

IQVIA Pakistan is the first multinational Contract Research Organization (CRO) to establish a dedicated clinical research operations unit in the country. Since 2019, the team has been delivering world-class clinical trial services that meet global standards while leveraging deep local expertise. 

IQVIA Pakistan collaborates closely with:

• Tertiary care hospitals
• Clinical trial units
• Key opinion leaders (KOLs) across the country

These partnerships support timely and reliable feasibility assessments, streamlining processes from site selection to initiation.

As a result:

• Average timeline from Site Selection Visit (SSV) to Site Initiation Visit (SIV): 5–6 months
• Average time for regulatory approvals: 4.5 months

Commitment to Quality

To ensure consistent quality delivery, IQVIA conducts quarterly training programmes with participating sites. These sessions:

• Reinforce data quality
• Support regulatory alignment
• Are regularly recognised during sponsor audits

Regulatory Support by DRAP

Approvals and Start-Up Timelines

The Drug Regulatory Authority of Pakistan (DRAP) has established a clear and efficient pathway for clinical trials to begin within 3–4 months. Key features include:

• Parallel IRB and NBC submissions to shorten timelines
• Regulatory reviews typically completed within 6 weeks
• Import licences granted in as few as 10 days
• Mandatory DRAP licensing for CROs and sites, ensuring sponsors work with qualified, GCP-compliant institutions

Compliance and International Standards

DRAP’s oversight is aligned with WHO and ICH guidelines, supporting global best practices. Highlights include:

• Bilingual patient materials required in Urdu and English
• Authorisation of clinical trial units for early-phase and complex studies
• Collaboration with CROs, investigators, and the Ministry of Health to ensure smooth import/export of study materials
• Introduction of digital submission portals to enhance transparency

These measures position Pakistan as a reliable setting for trials in:

• Oncology
• Hepatitis
• Infectious diseases
• Vaccines

Therapeutic Area Expertise

Proven Execution Across Complex Therapeutic Areas in Pakistan

Between 2018 and 2024, IQVIA Pakistan has successfully managed over 24 clinical trials across a wide range of disease areas. These include pivotal studies in Phase II, III, IIIb, and IV programmes, conducted in partnership with multinational sponsors.

Key strengths include:

• Execution of trials in high-burden disease areas
• Time-bound regulatory approvals
• Rapid patient enrolment across diverse sites

This track record demonstrates IQVIA Pakistan’s ability to deliver complex clinical programmes with precision, speed, and regulatory alignment.

RDS Services in Pakistan

IQVIA Pakistan offers comprehensive CRO services, supporting sponsors across Phase I–IV clinical trials and vaccine research. Our operational capabilities span the full study lifecycle, with a focus on regulatory alignment, site readiness, and data quality.

1. Site Identification & Feasibility

• Access to large treatment-naïve patient populations
• Feasibility assessments across 36 DRAP-approved hospitals
• Site activation within 30 days; up to 13 sites launched in a single month

2. Regulatory & Start-Up

• Parallel submissions to DRAP, NBC, and IRBs where permitted
• Country-specific templates for Clinical Trial Agreements (CTAs) and Delegation Letters
• Import license approvals typically processed within 10 working days
• Patient-facing materials and informed consent forms available in English and Urdu

3. Clinical Operations & Monitoring

• Nationwide CRA coverage across Karachi, Lahore, Islamabad, and Peshawar
• Risk-Based Monitoring (RBM) and traditional on-site monitoring models
• End-to-end study management from start-up through close-out
• Safety oversight and pharmacovigilance support

4. Contracts & Budget Management

• Contract negotiations aligned with DRAP and sponsor requirements
• Transparent budgeting frameworks with local compliance guidance

5. Quality & Compliance

• Dedicated quality resources conducting Focus Site Visits to uphold study integrity
• eTMF integration rate exceeding 95%; CTMS compliance over 97.7%
• Local quality control specialists ensuring audit readiness

6. Flexible Resourcing (FSP Models)

• Dedicated CRAs, CTAs, RSU staff, and QC support available
• Hybrid models supporting both IQVIA-led and sponsor-led studies

Regulatory Timelines with DRAP

Pakistan – The Emerging Clinical Trial Hub

• Pakistan is among the fastest-growing destinations for global clinical trials:
• 200M+ population with large treatment-naïve patient pools
• Fastest recruitment rates worldwide in multi-country programs
• Cost-efficient operations with English-speaking workforce
• Globally recognized infrastructure – JCI/ISO hospitals, WHO-inspected labs
• Strong DRAP collaboration and smooth MoH/site connectivity
• Economical site budget for clinical studies
• Smooth import and export process to manage biological supplies and samples 

Therapeutic Leadership Areas in Pakistan

Oncology Trials: Breast, ovarian, lung, ocular, pediatric oncology

Hepatitis Research: HBV, HCV, HDV, with leading liver & GI sites

Infectious Diseases: COVID-19, Influenza, Tuberculosis, Pneumonia

Gastroenterology & MASH Trials: Liver and GI research with global sponsors

Endocrinology & Diabetes: Addressing a burden of 34.5M adults with diabetes