FULL CLINICAL TRIAL MANAGEMENT
Meditrial is a full-service CRO partner with a remarkable record of 100% success in assisting clients to execute studies in medical centers of excellence throughout Europe.
Site Selection
Prior to the initiation of the clinical trial, the qualifications of the principal investigator and adequacy of the site must be verified and documented in an investigation site selection report. Sounds complicated? No worries, Meditrial knows how to select the right site for your trials.
Study Approval
Obtaining an approval for your study could be tricky if you get lost in submitting relevant study documents to competent authorities and ethic committees. Meditrial will follow every step for you from start-up study to completion.
Site Initiation
Our specialized team can define the activities required for the initiation of investigation sites in accordance with EN ISO 14155. Our monitoring plan seeks to check and document regulatory approval, to complete site opening procedures and prepare for enrollment of the first patient.
Clinical Data Management Biostatistics
Paper CRF are history now, everybody knows that. But we know that not all e-platforms are suitable for clinical data. Our electronic databases allow different types of data review to be performed while carrying out a study. Data review activity can support study data integrity by analysis of results trends and data collection status.
Risk-based Monitoring
There is no clinical trial without risks. Meditrial team will assess and define a risk plan associated with medical devices subjected to clinical investigations, in order to proactively react to those risks and mitigate the effects.
Safety Reporting
Meditrial team is highly skilled to perform procedures reporting modalities for Adverse Events (AEs), Serious Adverse Events (SAEs) and Device Deficiencies during pre-market clinical investigations of Medical Devices and Active Implantable Devices.
FULL SPECTRUM SERVICES
GLOBAL REGULATORY
US SERVICES
- US Agent
- FDA Regulatory Roadmap
- FDA Submission & Meetings
- Breakthrough Device Designation
- 513(g) Classification
- Premarket Notification | 510(k)
- De Novo Classification
- Request for Designation | Pre-RFD
- Investigational Device Exemption (IDE)
- Pre-Market Approval (PMA)
- Humanitarian HUD | HDE
- MDDT | DDT Qualification
- Reimbursement Coverage
EU SERVICES
- European Authorized Representative
- UK Responsive Person
- Swiss Representative
- In Country Registration | EUDAMED
- CE Mark Consulting
- MDR | IVDR Compliance
- Clinical Evaluation Report
- Performance Evaluation Report
- Risk Management
- Labeling | eLabeling
- Certified Translation
- Privacy GDPR Compliance
- Vigilance | Recalls
INTERNATIONAL
- Canada | Latin America
- New Zealand | Australia
- Israel | Japan | China | Korea
CLINICAL RESEARCH
TRIAL DESIGN
- Early Feasibility Studies EFS | FIH
- Full Clinical Trial Management
- Clinical Study Design | Protocol
- Clinical Development Plan
- Real Word Evidence | Registries
- R&D Management Consulting
- Clinical Study Dossier
TRIAL EXECUTION
- Site Selection & Qualification
- Clinical Trial Submissions
- Pivotal | Randomized | Adaptive
- Trials
SITE EFFECTIVENESS
- Patient Recruitment
- Site Relationship
- Patient Retention
- Investigator Training
- On-site & Remote Monitoring
- GCP Inspections
SAFETY MANAGEMENT
- Vigilance Management
- DSMB & CEC
- Online Adjudication
EVIDENCE GENERATION
- Biostatistics & Analysis Plan
- Data Management
- Real Time Data Analytics
- Performance Management
- Medical Imaging Core Labs
- Value Based Outcomes
PRODUCT DEVELOPMENT
NON CLINICAL PATHWAY
- Technology Assessment
- Market Analysis
- Development Strategy
- Usability | UX Processes
- Human Factors
- Pre-Clinical Testing Plan
- Biocompatibility Strategy
- Non Clinical/Animal Program for
- FDA
- Safety Profile for IND or IDE
- Non Clinical Protocols
- Advisory for Lab Test Execution
- Medical & Technical Writing
- Regulatory Due Diligence Support
KEY PRODUCT AREAS
- Healthtech | Medtech | IVD
- Combination Products
- Biotech
- Wearables
- SaMD | AI/ML | AR/VR
- Robotics
QUALITY ASSURANCE
- QMS | eQMS Setup and Support
- FDA QSIT, ISO 13485, ISO 9001
- CMDCAS Canada
- TGA Australia
- MDSAP
- Design Control
- Process Validation
- Technical Documentation
- EU MDR | VDR
- Post-Market Surveillance
