PHARMA & BIOTECH

Benefit from our expert CRO services for pharma and biotech.

By combining deep expertise with advanced solutions to streamline clinical trials, we enable biotech and pharma companies to reach critical milestones with quality results. Our support covers all phases.

Our support covers all phases, starting from early Phase I First-in-Human and Safety Studies to Phase II Proof-of-Concept and Dose Optimization. Additionally, we provide support for Phase III Pivotal Registration Studies, Phase IV Post-Marketing Real-World Evidence, and Investigator-Initiated Trials (IITs).

alt=""
PHARMA & BIOTECH

Benefit from our expert CRO services for pharma and biotech.

By combining expertise and advanced solutions to streamline clinical trials, we help biotechs and pharma companies achieve critical milestones with quality results.

alt=""
alt=""
PHARMA & BIOTECH

Benefit from our expert CRO services for pharma and biotech.

By combining expertise and advanced solutions to streamline clinical trials, we help biotechs and pharma companies achieve critical milestones with quality results.

  • Site Feasibility and Qualification
  • Site Contracting
  • Project Plans and ISF
  • Study Trainings
  • Project Oversight
  • Vendor Management
  • Study Logistics & Labelling
  • Investigator Payments
  • Central Laboratory Services
  • Clinical Labelling Services
  • Pre-Study Selection Visits
  • Site Initiation Visits
  • Routine Monitoring Visits
  • Remote Monitoring
  • Close Out Visits
  • Routine Site Management
  • CMC Regulatory Services
    • IND, CTA, IMPD, NDA, MAA, ANDA submissions
    • eCTD preparation and global dossier publishing
    • FDA, EMA & national agency interactions and negotiations
  • Regulatory Submissions to CA/IEC/IRB
  • Clinical audit
  • Safety Events Reporting (SAE, SUSAR)
  • Periodic Safety Reports (ASR, DSUR, PSUR)
  • Safety Management Plan
  • 24/7 Medical Monitoring

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

Translating complex information into clear
and engaging visuals, helping understand
the information effectively and quickly.

  • Presentation Decks
  • Diagrams
  • Infographics

 

  • Site Feasibility and Qualification
  • Site Contracting
  • Project Plans and ISF
  • Study Trainings
  • Project Oversight
  • Vendor Management
  • Study Logistics & Labelling
  • Investigator Payments
  • Central Laboratory Services
  • Clinical Labelling Services
  • Pre-Study Selection Visits
  • Site Initiation Visits
  • Routine Monitoring Visits
  • Remote Monitoring
  • Close Out Visits
  • Routine Site Management
  • CMC Regulatory Services
    • IND, CTA, IMPD, NDA, MAA, ANDA submissions
    • eCTD preparation and global dossier publishing
    • FDA, EMA & national agency interactions and negotiations
  • Regulatory Submissions to CA/IEC/IRB
  • Clinical audit
  • Safety Events Reporting (SAE, SUSAR)
  • Periodic Safety Reports (ASR, DSUR, PSUR)
  • Safety Management Plan
  • 24/7 Medical Monitoring

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

Translating complex information into clear and engaging visuals, helping understand the information effectively and quickly.

  • Presentation Decks
  • Diagrams
  • Infographics

 

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

We are very happy having Hemex for our clinical investigations. HEMEX stood out as the ideal partner due to their cutting-edge platforms for project management, communication and study conduct. Their extensive expertise in the field of anti-infectious and dental indications was instrumental in our project’s success. Moreover, the energy between our teams has been exceptional, and their youthful dynamism is advantageous for every collaboration. PerioTrap is grateful for HEMEX’s support and looks forward to continuing their collaboration in the future.

Portrait of Pierre Tangermann

Pierre Tangermann

CEO, PerioTrap


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 understands how to respond to the needs of the customer. In our case, the last project had to be resized due to budget cuts. HEMEX, thanks to their internal expertise, was able to offer us a good solution that fully met our needs and also the budget.

Portrait of dr. Martin Güttinger

Dr. Martin Güttinger 

Head Rare Disease & Medical, Gebro Pharma  

Request more information

“Pharmaceutical and biotech SMEs require flexibility and prompt attention to navigate clinical trials. We form close partnerships with sites and act as advocates for our sponsors, ensuring a collaborative and supportive process.”

Sandra Müller Lettlova
Clinical Operations

Request more information

“Pharmaceutical and biotech SMEs require flexibility and prompt attention to navigate clinical trials. We form close partnerships with sites and act as advocates for our sponsors, ensuring a collaborative and supportive process.”

Sandra Müller Lettlova
Clinical Operations

Request more information

“Pharmaceutical and biotech SMEs require flexibility and prompt attention to navigate clinical trials. We form close partnerships with sites and act as advocates for our sponsors, ensuring a collaborative and supportive process.”

Sandra Müller Lettlova
Clinical Operations