MRCRO

Phase I-IV & BA/BE Studies

Collaborate with us to unleash the complete potential of your research, from the earliest discoveries to the final patient care solutions.

Clinical Capabilities

Phase I – IV Studies

  • Phase I to III Interventional trials
  • Phase IV (PMS) Observational / Interventional Studies
Therapeutic Areas

BA/BE Studies

Enabling sponsors with the monitoring and management services in collaboration with national & international BA/BE centers.

Study Startup

  • Protocol Design
  • Statistical Analysis Plan
  • CRF Design
  • Investigator Selection
  • Feasibility /Selection Financial Aspects
  • Regulatory Management
  • IT Systems (CTMS)
  • Document Management (QMS-9001 & ICH-GCP)
  • Training (GCP, Protocol, Safety, SOPs)

Study Completion

  • Protocol Review
  • Study Oversight
  • Study Closeout
  • Data Reconciliation
  • Safety Review
  • Regulatory Management
  • IMP Retrieval /Destruction
  • QA, QC, Audit
  • Archiving

Study Conduct

  • Benefit / Risk Analysis
  • Endpoint Evaluations
  • Data Reviews
  • More Extensive Document/Data Reviews
  • Clinical Study Reports
  • Regulatory Requirements – Global, Local
    Country (DRAP)

Submission

  • Protocol Compliance
  • Protocol Deviations
  • Protocol Amendments
  • Subject Recruitment
  • Data Entry
  • IMP Management
  • Investigator Oversight
  • Trial Master File Maintenance
  • Monitoring
  • Safety – AE reporting
  • Interim Analysis
  • QA, QC, Audit

Study Startup

  • Protocol Design
  • Statistical Analysis Plan
  • CRF Design
  • Investigator
  • Feasibility /Selection Financial Aspects
  • Regulatory Management
  • IT Systems (CTMS)
  • Document Management (QMS-9001 & ICH-GCP)
  • Training (GCP, Protocol, Safety, SOPs)
  • Study Conduct

  • Benefit / Risk Analysis
  • Endpoint Evaluations
  • Data Reviews
  • More Extensive Document/Data Reviews
  • Clinical Study Reports
  • Regulatory Requirements – Global, Local Country (DRAP)
  • Study Completion

    • Protocol Review
    • Study Oversight
    • Study Closeout
    • Data Reconciliation
    • Safety Review
    • Regulatory Management
    • IMP Retrieval /Destruction
    • QA, QC, Audit
    • Archiving

    Submission

    • Protocol Compliance
    • Protocol Deviations
    • Protocol Amendments
    • Subject Recruitment
    • Data Entry
    • IMP Management
    • Investigator Oversight
    • Trial Master Files Maintenance
    • Monitoring
    • Safety – AE reporting
    • Interim Analysis
    • QA, QC, Audit

    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