MRCRO

Navigating the Complexities of Real World Data : A Nephrology Perspective

Case Study

Background

Pakistan has a very high burden of renal pathologies; this has been known for a long time. However, the exact extent of prevalence and its impact on healthcare has not been gathered officially. Thus, an initiative was taken by the Pakistan Society of Nephrology (PSN) in 2018 to initiate a
real-world evidence registry of patients on hemodialysis across Pakistan. The aim was to gather the demographics, health status, basic lab parameters and extent of complications in End-Stage Kidney Disease (ESKD) patients. The vision was not only to create a dynamic platform for gathering information but also to analyze & assess the magnitude of the problem associated with the management of ESKD. This registry – Pakistan Renal Data System (PKRDS) is a dedicated hemodialysis registry tailored to the needs of Pakistan’s healthcare system.
Metrics Research got an opportunity to contribute to this PKRDS initiative in 2021, when PSN required assistance in progressing to a wider geography and overcoming some real-time challenges in data gathering.

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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