Expert CRO Services for Medical Devices and In-vitro Diagnostics

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Expert CRO Services for Medical Devices and In-vitro Diagnostics

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Expert CRO Services for Medical Devices and In-vitro Diagnostics

  • 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

 

  • 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

 

Get a proposal

Software 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.

Software 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.

“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 Nicosur Pop
Clinical Operations

Portrait of Gheorghe Pop at Hemex AG

“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 Nicosur Pop
Clinical Operations

Portrait of Gheorghe Pop at Hemex AG

“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.”

Portrait of Gheorghe Pop

Dr. med. Gheorghe Nicosur Pop
Clinical Operations

Get in touch