Full-Service Clinical Research Support
Medex CRO provides end-to-end clinical research services, covering all critical stages from study design to execution and close-out
Medex CRO delivers structured Phase I–IV clinical operations in full compliance with approved protocols and regulations.
We manage study start-up, site activation, and operational oversight to ensure predictable timelines and compliant execution.
Our operational model emphasizes:
Risk-based planning
Transparent milestone tracking
Site performance oversight
Budget control and accountability
Proactive issue escalation
We execute studies with disciplined coordination, ensuring that operational processes reinforce — not compromise — scientific objectives.
Medex CRO develops scientifically robust and clearly structured clinical documentation aligned with international regulatory standards.
We design and draft:
Clinical trial protocols and amendments
Informed consent forms
Investigator brochures
Clinical study reports
Regulatory submission documents
Our physician-led structure ensures that clinical rationale, endpoint integrity, and feasibility considerations are embedded early in document development.
Navigating regulatory requirements in emerging markets requires structured expertise.
Medex CRO manages regulatory submissions and interactions with local authorities in Türkiye, ensuring compliance while minimizing avoidable delays.
We:
Prepare and submit regulatory dossiers
Coordinate authority interactions
Oversee response management
Track approval milestones
Maintain ongoing regulatory compliance
Our proactive regulatory mapping reduces uncertainty and facilitates predictable study initiation.
Ethical alignment is integrated into every stage of study planning and execution.
Medex CRO prepares and submits ethics committee and institutional review board applications, coordinates authority authorizations, and manages responses to committee queries throughout the study lifecycle.
We ensure:
Complete and accurate ethics packages
Transparent communication with committees
Timely query resolution
Continuous compliance monitoring
This structured approach safeguards patient safety and study continuity.
We provide comprehensive support for the preparation, negotiation, and execution of Clinical Trial Agreements between sponsors, investigational sites, and other stakeholders.
Our team coordinates closely with legal, regulatory, and site personnel to ensure that contractual terms, budgets, and responsibilities are clearly defined and compliant with applicable regulations.
By managing timelines, facilitating negotiations, and ensuring proper documentation, we help accelerate study start-up while protecting the interests of all parties involved.
Realistic feasibility is essential for predictable enrollment.
Medex CRO conducts data-informed site feasibility assessments across Türkiye, leveraging strong investigator relationships and therapeutic expertise.
We:
Evaluate site capability and patient access
Validate enrollment projections
Coordinate essential document collection
Facilitate contract processes
Execute site readiness assessments
Our feasibility model prioritizes realism over optimism, protecting sponsor timelines and investment.
Medex CRO oversees monitoring activities in line with risk-based monitoring principles to ensure data integrity, protocol compliance, and participant safety.
We coordinate:
On-site and remote monitoring
Source data verification
Issue tracking and resolution
Corrective and preventive action processes
Our structured oversight model strengthens inspection readiness and quality consistency.
Patient safety remains a non-negotiable priority.
Medex CRO executes pharmacovigilance processes in compliance with applicable regulations and international guidelines.
We manage:
Adverse event reporting
Safety documentation
SAE reconciliation
Safety communication workflows
Regulatory safety reporting timelines
Our safety oversight model ensures regulatory alignment and rapid issue response.
High-quality clinical data is central to regulatory success.
Medex CRO manages data review processes to ensure accurate, complete, and consistent datasets.
Our services include:
Data validation and cleaning
Database oversight
Vendor alignment
Data reconciliation processes
We facilitate transparent data flow between sites, sponsors, and external vendors to minimize discrepancies and delays.
Medex CRO delivers biostatistical expertise integrated into study planning and analysis.
We provide:
Statistical input to study design
Sample size calculations
Statistical analysis planning
Interim and final analysis oversight
Interpretation of clinical outcomes
Our analytical approach aligns statistical rigor with clinical relevance and regulatory expectations.
Misaligned vendors are a common source of delay and budget escalation.
Medex CRO coordinates external vendors and laboratories involved in clinical studies, ensuring defined responsibilities and operational alignment.
We:
Oversee vendor communication
Align timelines and deliverables
Track performance metrics
Manage laboratory coordination
Facilitate issue resolution
Our structured vendor management minimizes operational friction and protects study continuity.
Medex CRO manages structured study close-out activities in accordance with regulatory and ethical requirements.
We coordinate:
Final documentation
Site close-out visits
Regulatory notifications
Study report finalization
Archiving processes
This disciplined close-out process ensures inspection readiness and complete documentation integrity.
Medical Device Clinical Investigations
Medex CRO executes medical device clinical investigations in accordance with applicable regulations and ethical standards, ensuring scientifically sound and operationally controlled study conduct.
MDR Clinical Evaluation (EU MDR)
We manage clinical evaluation activities under the EU Medical Device Regulation (MDR), including:
- Clinical data review and integration
- Gap analysis
- Literature evaluation
- Clinical evaluation report preparation
Our structured methodology aligns clinical evidence with conformity assessment requirements.
Post-Market Clinical Follow-up (PMCF)
Medex CRO designs and executes Post-Market Clinical Follow-up studies to monitor device performance and safety in real-world clinical settings.
We ensure that PMCF strategies generate meaningful and regulator-ready evidence.
Medical Device Post-Market Surveillance
We manage post-market surveillance activities, including:
- Clinical data collection
- Safety monitoring
- Regulatory reporting
- Ongoing performance evaluation
Our approach integrates regulatory compliance with long-term risk.
Usability & Performance Studies
Medex CRO designs and executes usability and performance studies assessing medical device functionality under intended conditions of use.
We ensure methodological rigor while maintaining practical feasibility.
Medical Device Regulatory & Ethics Submissions
We prepare and submit regulatory and ethics documentation for medical device clinical investigations, coordinate authority interactions, and oversee submission follow-up to ensure timely approvals.