MRCRO

FDA Approved IND Trial in Pakistan

Case Study

Successful Execution of a Rescue Strategy

COVID-19 pandemic led to a great chaos, impacting every walk of life. Back in 2020-2021, policy makers, health care industry and researchers were all striving to bring solutions for the management of this life-threatening disease. A drug development biopharmaceutical company developed a super anti-inflammatory and had gotten the IND approval from US-FDA for managing hyper-inflammatory response in the body due to severe COVID-19 infection. Initially the trial was planned to be conducted in US & Mexico sites only. But due to recruitment constraints in the existing sites, a rescue strategy was urgently required. Hence, Metrics Research was approached to develop a feasibility to include Pakistan in the mix.

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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