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.

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

Let’s speed up your clinical trial!

How we can help

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

Let’s speed up your clinical trial!

How we can help

We 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.

Portrait of Gora Conley CEO Annaida Switzerland

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

We 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

“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