Optimizing Medtech and IVD activities with specialized CRO services.
Optimizing Medtech and IVD activities with specialized CRO services.
Clinical Studies
- Clinical Evaluation Report
- Post-Market Surveillance/Post-Market Clinical or
Performance Follow-Up (PMCF/PMPF) - Notified Bodies Selection Support
- GCP compliance – ISO 14155
Study Start-up
- Site Feasibility and Qualification
- Site Contracting
- Project Plans and ISF
- Study Trainings
Clinical Study Management
- Clinical Trial Management
- Vendor Management
- Study Logistics
- Investigator Payments
Clinical Monitoring
- Pre-Study Selection Visits
- Site Initiation Visits
- Routine Monitoring Visits
- Remote Monitoring
- Close Out Visits
- Routine Site Management
Regulatory Affairs/Quality Assurance
- Clinical Audits
- Clinical Trial Application to competent authorities in Switzerland, EU, USA
- Data Protection
Data Management
- eCRF Design and Maintenance
- Query Generation and Resolution
Biostatistics and Statistical Programming
- Sample Size Calculation
- Randomization Schedules
- Statistical Programming and Analysis
- Statistical Analysis Report
Medical Writing
- Protocol Synopsis
- Full Study Protocol
- Informed Consent Forms
- Clinical Study Report
Device Safety
- Reports of SADE, SUSAR, DSUAR
- Periodic Safety Reports
- Safety Management Plan
- 24/7 Medical Monitoring
Regulatory Affairs
- Gap Analysis
- Technical Documentation and Product Registration
- MDR CE Marking
- IVDR CE Marking
- EUDAMED
- Risk Management ISO 14971
- Conformity Assessments for EU, US, and CA
- Global Registration
ISO 13485 – Quality Management System for Medical Devices
- Quality Strategy
- QMS Implementation
- QMS Maintenance
- Internal Audit
Information and Presentation Design
Translating complex information into clear and engaging visuals, helping understand the information effectively and quickly.
- Presentation Decks
- Diagrams
- Infographics
Adaptable and swift response to changesSoftware Solutions for Clinical Development
We can use the customer’s preferred software or suggest one of our pre-validated solutions, that meet specific needs, including compliance requirements, user interface preferences, scalability, and integration capabilities.
Electronic Trial Master File (eTMF)
Clinical Trial Management System (CTMS)
Electronic Data Capture (EDC)
Pharmacovigilance (PV)
Electronic Quality Management System (eQMS)
Working together
- Adaptable and swift response to changes
- Emphasis on smaller project prioritization
- Dedication and competence
Client testimonial
HEMEX team merges extensive expertise in regulatory and clinical operations with a strong commitment to supporting its clients, ensuring successful clinical advancement. Especially significant for our startup is that HEMEX provides the flexibility, which enables rapid adaption to evolving demands and trial designs. On top of being an outstanding service provider, HEMEX also became an important partner of Bottneuro, supporting us in translating our neuromodulation therapy into clinical application and therefore offering help to Alzheimer’s patients in need.
Dr. Alois C. Hopf
CSO & Co-Founder, Bottneuro
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“Biostatistics is the core of clinical trial management, driving precision and reliability throughout the process. It involves developing the study design, defining outcome measures and endpoints, conducting statistical analyses, evaluating risk-benefit assessments, and providing clinical interpretation of study results.”
Dr. med. Gheorghe Nicusor Pop
Clinical Operations