Bilateral Meetings
- Thursday (1:30pm – 6:00pm)
Comac Medical offers Early Phase Clinical Development, Start-up & Monitoring of Clinical Trials Phase I-IV and BA/BE, Project Management, Site Management, Patient Recruitment Services, Regulatory Consulting, Medical Writing, Biometric Services, Pharmacovigilance, Bioanalysis, Safety Laboratory Services, Independent Quality Assurance.
As part of the Early Phase Clinical Development operations, the company has its own University Hospital-based Clinical Research Unit with a large patient/ healthy volunteers database and extensive referral physicians network.
Comac Medical has been chosen to participate and has successfully completed Phase 1 of the SME Instrument of Horizon 2020. The company has received a Seal of Excellence by the European Commission for its Horizon 2020 SME Instrument Phase 2 project proposal.
Clinical Trial Execution
• Early Phase Trials (I/IIa and BA/BE)
• Interventional Phase II/III & IIIb/IV Trials
• Clinical Monitoring
• Risk-based Monitoring
• Site Start-Up
• Regulatory Affairs
• Project Management
• Clinical Biostatistics
• Clinical Data Management
• Central and Bioanalytical Laboratory
• Safety & Pharmacovigilance
- Outsourcing co-operation
- Technical co-operation
Early Phase Clinical Development
Conducting Early Phase studies at its own Clinical Research Unit and Partnering Clinical Centers with patients and healthy volunteers, such as:
• First-in-Human (incl. in patients)
• Proof of Concept
• Dose escalation (SAD, MAD)
• Bioavailability
• Bioequivalence (incl. in patients)
• Dose proportionality
• Food/ drug interaction
• Drug/ drug interaction
• Age/ gender interaction
• Phase I PK and PD testing
• Pediatric trials
• Hepatic and renal impairment trials
- Technical co-operation
- Outsourcing co-operation
Clinical Site Management
• Separate structure
• More than 60 sites database
• Site training – initial & ongoing
• Clinical supply activities & issues resolution
• Data entry (CRF / EDC) & Quality control
• Scheduling project activities
• Technical support
- Outsourcing co-operation
- Technical co-operation
Advisory Services
• Clinical Trial Planning & Design
• Generics Clinical Development
- Outsourcing co-operation
- Other
Patient Recruitment Services
Patient Recruitment Services via own Patient recruitment / Patient engagement models
- Outsourcing co-operation
- Other
Independent Quality Assurance Services
The Quality Assurance team consists of dedicated quality assurance (QA) specialists.
The team can provide regulatory inspection support such as conduct mock regulatory inspections, provide site training and support the preparation of responses to regulatory findings.
- Outsourcing co-operation
- Other