MRCRO

Regional Landscape

Pakistan is providing an opportunity for global stakeholders to utilize the potential of its clinical trial landscape.

Pakistan’s Clinical Trial Landscape

Clinical Trial Sites

DRAP Approved Clinical Trial Sites
  • Generalized for Phase-III & IV Clinical Trials: 19
  • Generalized for All Phases ( Phase-I,
    II, III, IV ) Clinical Trials: 9
  • Generalized for Phase-III
    Clinical Trials: 7
  • Generalized for Phase-IV
    Clinical Trials: 3
  • Trial Specific: 53

Infrastructure & Facilities

  • Certified Central Laboratories.
  • GMP-certified manufacturing plants.
  • Clinical trial unit-specific pharmacies with ultra-freezing storage capacity.
  • Advanced data management systems and methodologies

Compliance

  • Since 2002, ICH-GCP guidelines implementation for clinical trial conduct have been mandated by health authorities in Pakistan.
  • In 2012, after the formation of the Drug Regulatory Authority of Pakistan (DRAP), formal regulations, i.e. bio-study rules 2017 and conduct of clinical trial guidelines, were introduced to oversee clinical trials in Pakistan.

Robust Regulatory Process & Approvals

  • Institutional Review Board (IRB), National Bioethics Committee (NBC), and Drug Regulatory Authority of Pakistan (DRAP) are responsible for approving clinical trials in Pakistan.
  • Timelines for approval:
    • IRB : 02-04 weeks
    • NBC : 06-08 weeks
    • DRAP: 08-12 weeks

Diverse Population

Pakistan’s diverse demographics encompass various ethnicities, presenting a unique opportunity for researchers to achieve broader research outcomes.

Accreditations & Certifications

JCI / ISO / DRAP approved and GCP compliant, well-established clinical trial sites.

Expertise

Availability of PIs (Principal Investigators) with experience in conducting EMA (European Medicines Agency), UK-MHRA & US-FDA approved trials.

Cost Effective Trials

Maintaining high-quality research operations at a lower operational cost

Availability of Internationally accredited and certified facilities for the conduct of clinical trials in Pakistan

Clinical Trial Sites in Pakistan

Clinical Trial sites in Sindh
0
Clinical Trial sites in Balochistan
0 0
Clinical Trial sites in Punjab
0
Clinical Trial sites in KPK
0 0

Clinical Trials In Pakistan

By Indication

Distribution of Clinical Trials in Pakistan

Source: Mumtaz H, Haider SMA, Neha F, Saqib M, Nadeem A, and Seikha Z. Clinical trials landscape in a lower-middleincome country (Pakistan). Journal of Clinical and Translational Science 8: e7, 1–7. doi: 10.1017/cts.2023.701

Source : https://doi.org/10.35845/kmuj.2023.23355

Access Local Regulatory Guidelines

Trial Insurance

  • Customized coverage for clinical trial participant.
  • Risk assessment and tailored insurance solutions
  • Compliance with international and national level regulations.

IT Solutions

  • Enabling collaborations with the EDC tool vendor.
  • Providing IT-enabled data management support.
  • Integrating data from various sources to facilitate efficient data management.
  • Monitoring site performance for optimizing the use of resources.
  • Maintaining audit trails for tracking changes to ensure data integrity through EDC tools.

Specimen Shipment & Handling

  • Secure and compliant handling of biological specimens.
  • Temperature-controlled packaging and shipping.
  • Collaborative services with global logistics network for specimen transportation.
  • Ensuring regulatory compliance for international shipments.
  • Expertise in managing various specimen types, including blood, tissue, and urine.

Clinical Trial Ancillary Supplies

  • Enabling the sponsors with the ancillary supplies for clinical trials.
  • Comprehensive inventory management and tracking.
  • Customizing supply chain solutions to meet trial-specific needs.
  • Ensuring timely supply services.
  • Providing cost efficient solutions to optimize trial budgets.

IP/ Placebo / Comparator Sourcing

  • In-house services for sourcing of Investigational Products, comparators, and placebos.
  • Collaboration with suppliers and manufacturers.
  • Experienced team for procurement and logistics management.

Central Laboratory Testing

  • Collaborative services for diagnostic and clinical testing.
  • Enabling sponsors to evaluate diverse range of clinical endpoints through diagnostic tests.
  • Meeting quality standards and regional regulatory compliance.
  • Standardized procedures for authentic and credible outcomes.

Percentage Of Total Contributions

Head Office:

Karachi: Plot No. B-10, Block 16, WCHS, KDA Scheme No.24, Gulshan E Iqbal, Karachi – Pakistan.

Regional Office:

Flat No. 2, first floor, 2-C Plaza ( First floor of M.A Dental Clinic) Pakeeza Market, Sector I-8/4, Islamabad, Pakistan

Regional Presence:

  • Sindh
  • Punjab
  • Balochistan
  • Khyber Pakhtunkhwa