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.

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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.

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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.

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  • 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
  • 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
  • Quality Strategy
  • QMS Implementation
  • QMS Maintenance
  • Internal Audit

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!

Contact us
  • 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
  • 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
  • Quality Strategy
  • QMS Implementation
  • QMS Maintenance
  • Internal Audit

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!

Contact us

We use the following pre-validated software solutions in our daily practice

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.

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.

An EDC system is used to collect and manage electronic data from clinical trials, such as patient demographics, medical histories, and study outcomes.

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.

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 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.

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.

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.

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.

We use the following pre-validated software solutions in our daily practice

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.

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.

An EDC system is used to collect and manage electronic data from clinical trials, such as patient demographics, medical histories, and study outcomes.

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.

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.

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.

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.

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.

“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

Portrait of Gheorghe Pop

“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

Portrait of Gheorghe Pop

Next steps to speed up your clinical journey.

Step 1

Sign NDA and receive request for proposal RFP

Step 2

Get a ball-park budget within 48 hours

Step 3

Bid defence and detailed proposal

Step 4

Signature of contract

Step 5

Kick-off meeting

Next steps to speed up your clinical journey.

Step 1

Sign NDA and receive request for proposal RFP

Step 2

Get a ball-park budget within 48 hours

Step 3

Bid defence and detailed proposal

Step 4

Signature of contract

Step 5

Kick-off meeting

We are committed to being the integrated partner in your clinical journey.

Speed up your clinical journey

We are committed to being the integrated partner in your clinical journey.

Speed up your clinical journey