MRCRO

Pharmacovigilance

Providing pharmacovigilance services through Qualified Person
for Pharmacovigilance (QPPV).

  • Standard Operating Procedures (SOP) development.
  • Safety management plan.
  • Support services for local regulatory compliance.
  • Development & process of Individual Case Safety Reporting (ICSR).
  • Developing and submitting aggregate safety reports.
  • Clinical trial safety monitoring.
  • SAE/AE reporting.
  • Facilitating clients with independent Data Safety Monitoring Board (DSMB).
  • Experienced Qualified Person for Pharmacovigilance (QPPV) & Local Person for Pharmacovigilance (LPPV).
  • Reporting of Individual Case Safety Reporting (ICSR).
  • Developing and submitting aggregate safety reports.
  • Risk management plan.
  • Pharmacovigilance master file maintenance.
  • Utilizing sponsor’s approved/agreed safety database for clinical trial safety management.
  • Query resolution.
  • SAE/AE reporting.
  • Pharmacovigilance-based data reconciliation.
  • Safety data reporting.
  • Safety data validation.

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