GlobalCRO services for MedTech, IVD & Digital Health
We plan, manage, conduct and report your clinical study. Our partnership with your team proves safety and efficacy to obtain market approval.
CRO services for MedTech, IVD & Digital Health
We plan, manage, conduct and report your clinical study. Our partnership with your team proves safety and efficacy to obtain market approval.
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
Medical/Biostatistics
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
Fast & effective communicationWe use the following pre-validated software solutions in our daily practice
eTMF
An eTMF is a digital repository used to store and manage documents related to clinical trials, such as trial protocols, investigator brochures, and patient consent forms.
CTMS
A CTMS is a software platform used to manage the operational aspects of clinical trials, including study planning, site management, and tracking of study participants.
EDC
An EDC system is used to collect and manage electronic data from clinical trials, such as patient demographics, medical histories, and study outcomes.
PV
A PV system is used to monitor and evaluate the safety of drugs and medical devices in the market, and to identify and manage adverse events and safety signals.
eQMS
An eQMS is used to manage compliance and quality processes within organizations, such as document control, audits, training, and corrective actions.
We also work with our clients’ software systems.
What you can expect from us
- Fast & effective communication
- Highest quality
- Maximized efficiency
- Flexible software solutions
What clients say about us
Dealing with HEMEX was a very pleasant experience. We felt very competently advised at all times and will be glad to use their services again in the future.
Dr. Daniela Marino
CEO, CUTISS
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
With its impressive commitment to advance and fund healthcare innovations, its deep understanding of startup needs and its solid expertise in supporting regulatory and clinical operations, HEMEX is an exceptional partner that has been and continues to be instrumental in our journey.
Mathieu Horras
CEO, ASPIVIX
From the start of Resistell, HEMEX supports our company in the clinical operations and also back us with its investment arm. The understanding of startup needs, makes HEMEX a unique partner in our journey to the market.
Dr. Danuta Cichocka
CEO, Resistell
“To maintain efficient processes and quality practices, we establish and maintain reliable standard operating procedures. As an ISO 9001 & 13485-certified company, we will ensure you are as well!”
Gheorghe
Medical Monitor
Next steps to speed up your clinical journey.
Sign NDA and receive request for proposal RFP
Get a ball-park budget within 48 hours
Bid defence and detailed proposal
Signature of contract
Kick-off meeting
We are committed to being the integrated partner in your clinical journey.