End-to-endclinicalresearchservices
From monitoring and project management to quality, regulatory, and medical writing, delivered as one integrated team or as individual functional support.
Nine integrated service areas
Engage Meridax across the full clinical development lifecycle, or select the specific functional support your study needs.
Clinical Operations
Comprehensive operational support for clinical trials across all phases.
- Clinical Monitoring
- Site Qualification
- Site Initiation
- Interim Monitoring
- Close-Out Visits
- Remote Monitoring
- Risk-Based Monitoring
- Co-monitoring
- Source Data Verification
- Source Data Review
- ISF Reviews
- Trial Coordination
Clinical Project Management
End-to-end project leadership that keeps studies on schedule, within budget, and compliant.
- Study Planning
- Project Coordination
- Vendor Oversight
- Timeline Management
- Budget Oversight
- Risk Management
- Stakeholder Communication
- Sponsor Reporting
- Study Governance
Study Start-Up & Regulatory
Accelerating study activation through efficient regulatory planning and site start-up.
- Site Feasibility
- Site Identification
- Ethics Submissions
- MHRA Submission Support
- Regulatory Documentation
- Essential Document Review
- Site Activation
- Regulatory Maintenance
Trial Master File (TMF)
Maintaining inspection-ready documentation throughout the study lifecycle.
- TMF Set-up
- TMF Maintenance
- Quality Control
- TMF Rescue Projects
- Reconciliation
- Archiving
Quality Assurance & Compliance
Robust quality systems that promote regulatory compliance and operational excellence.
- Internal Audits
- Vendor Audits
- GCP Compliance Reviews
- Inspection Readiness
- CAPA Management
- Quality Metrics
- Risk Assessments
- SOP Development
- QMS
Clinical Trial Consulting
Strategic consulting that strengthens clinical research capabilities.
- Development Strategy
- CRO Oversight
- Operations Optimisation
- Process Improvement
- Regulatory Strategy
- Inspection Readiness
- QMS
- Excellence Programmes
Pharmacovigilance Oversight
Supporting sponsor safety responsibilities through proactive oversight.
- Safety Oversight
- SAE Oversight
- Vendor Oversight
- Safety Documentation Review
- PV Compliance Support
Clinical Data Management
Supporting high-quality clinical data throughout the study lifecycle.
- Data Review
- Query Management
- Data Cleaning
- Database Lock Support
- Data Integrity Oversight
Medical Writing
Professional scientific documentation supporting clinical development.
- Clinical Trial Protocols
- Monitoring Plans
- SOP Development
- Clinical Study Reports
- Regulatory Documents
- Investigator Materials
One integrated team, or the exact functional support your study needs.
Full-service delivery
End-to-end clinical operations and project management, run as an extension of your team.
Functional support
Individual services such as monitoring, TMF, QA, regulatory, or medical writing.
Advisory & rescue
Independent consulting, oversight, and rapid recovery when studies need it.
Quality is designed into every process, not inspected at the end.
Quality is the foundation of everything we deliver. Every Meridax engagement is built on competent people, robust quality systems, and risk-based thinking, with senior oversight and continuous improvement aligned to ICH-GCP E6(R3) and MHRA expectations.
Competent professionals
Experienced, GCP-trained clinical staff on every engagement.
Robust quality systems
SOPs, QMS and CAPA processes that stand up to inspection.
Risk-based thinking & oversight
Proactive risk identification and effective study oversight.
Metrics & continuous improvement
Measured performance and a culture of getting better.
Let’s scope your study together.
Tell us about your programme and we will recommend the right mix of services, senior expertise, and delivery model for your objectives, timelines, and budget.