MRCRO

Quality Management System

Our Quality Management System (QMS) consisting of policies and SOPs, aligned with Good Clinical Practice (GCP) and regulatory standards. This ensures the consistent delivery of high-quality clinical research services and training, exceeding client expectations.

Our Commitment to Quality

Our Commitment to Quality

Risk-Based Approach

Project Planning

Project Execution

Identify Critical Areas / Processes

Conduct Early / Pre-Risk Assessment

Risk Management Strategy

Develop Key Risk Indicator (KRI) and Plan Action

Focus

Qualifications, Audits, Certification & Accreditations

2019
2020
2021
2022
2023
2024

2019

  • Qualified by global biotechnology company to monitor clinical study project for US-FDA approved trial

2020

  • Audited & licensed by Drug Regulatory Authority of Pakistan(DRAP)

2021

  • Qualified by National & International research centers for BE study projects
  • Audited by SGS & UKAS for ISO-9001 Standards & Quality Management System.

2022

  • Qualified by multiple global leading pharmaceutical organizations for clinical study project
  • Audited by Australia based CRO for clinical study project
  • CPD certification for training & development program

2023

  • License renewal by Drug Regulatory Authority of Pakistan (DRAP)

2024

  • Audited by a USA-based Contract Research Organization (CRO).

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