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.
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
- Regulatory Submissions to CA/IEC/IRB
- Clinical Trial Application Submissions
- 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 & 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 practise.
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
HEMEX has been instrumental in Annaida Technologies’ progress. They were the first to recognize our potential and acted swiftly to support our development. We wouldn’t be where we are without their help.
Dr. Gora Conley
CEO, Annaida Technologies
Starting from our first meeting with HEMEX, we have gained a lot of value from their life science experience and knowledge. We have received continuous support from HEMEX that has brought Hi-D Imaging one step further towards our goals.
Dr. Özge Karakas
COO, Hi-D Imaging
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 offers us great support on various levels thanks to their very good network of experts in different fields. We appreciate HEMEX’s dedicated commitment in supporting our companies development.
Mathias Wipf
CEO & Co-founder, MOMM Diagnostics
HEMEX provides Scailyte a range of services, from administrative to highly specialized regulatory and clinical development support. Working at HEMEX incubator, whenever we have a question, we can immediately address it. We’re happy to continue our journey with such a trusted partner.
Dr. Peter Nestorov
CEO, Scailyte
HEMEX supports us in marketing and sales, negotiating with industry partners and regulations. Their team is highly dedicated and delivers always on time and in high quality. HEMEX is giving us the support we wished for.
Tim Pfister
CEO, LiVET
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
We have worked with HEMEX on several topics, including fundraising and communication. They have supported us with their expertise and network. We value this partnership, and we look forward to our continued collaborations.
Eugenie Nicoud
COO, Sedimentum
From the very beginning Macu4 relied on social media activities to reach people, who would support our vision and mission. We decided to work with HEMEX, a partner at the heart of the startup scene and with a good understanding of our needs. What we appreciated a lot was that HEMEX not only saw us as a client but also believed in what we do and why we do it.
Myriam Lingg
CEO & Co-Founder, Macu4
Working with HEMEX was seamless, easy and very fast. They delivered quickly and iterated whenever we had changed our mind about something, helping us beyond what we had specifically asked for in the beginning of the project. The quality and level of service are both outstanding. We are very happy with their work.
Renée S. Gutiérrez
Behavioral Science Lead, Roche
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
“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!”
Vanja
Head of Clinical Operations
Next steps to speed up your clinical journey.
Signed NDA and received 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.