CRO services for Pharma & Biotech

We plan, manage, conduct and report your clinical study. Our partnership with your team proves safety and efficacy to obtain market approval.

alt=""

CRO services for Pharma & Biotech

We plan, manage, conduct and report your clinical study. Our partnership with your team proves safety and efficacy to obtain market approval.

alt=""
alt=""

CRO services for Pharma & Biotech

We plan, manage, conduct and report your clinical study. Our partnership with your team proves safety and efficacy to obtain market approval.

Arrow down
  • Site Feasibility and Qualification
  • Site Contracting
  • Project Plans and ISF
  • Study Trainings
  • Project Oversight
  • Vendor Management
  • Study Logistics
  • Investigator Payments
  • Pre-Study Selection Visits
  • Site Initiation Visits
  • Routine Monitoring Visits
  • Remote Monitoring
  • Close Out Visits
  • Routine Site Management
  • Clinical Audits
  • Clinical Trial Application Submissions (CTIS)
  • Regulatory Submissions to CA/IEC/IRB
  • Data Protection
  • 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

 

Let’s speed up your clinical trial!

Contact us
  • Site Feasibility and Qualification
  • Site Contracting
  • Project Plans and ISF
  • Study Trainings
  • Project Oversight
  • Vendor Management
  • Study Logistics
  • Investigator Payments
  • Pre-Study Selection Visits
  • Site Initiation Visits
  • Routine Monitoring Visits
  • Remote Monitoring
  • Close Out Visits
  • Routine Site Management
  • Clinical Audits
  • Clinical Trial Application Submissions (CTIS)
  • Regulatory Submissions to CA/IEC/IRB
  • Data Protection
  • 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

 

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 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.

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.

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.

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 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.

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.

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.

“HEMEX’s CRO team is multinational, diverse, and has a strong academic and clinical background. Our main goal is to make your clinical trial a success story.”

Sandra
Clinical Operations

Portrait of Sandra Lettlova, Hemex AG

“HEMEX’s CRO team is multinational, diverse, and has a strong academic and clinical background. Our main goal is to make your clinical trial a success story.”

Sandra
Clinical Operations

Portrait of Sandra Lettlova, Hemex AG

Next steps to speed up your clinical journey.

Sign NDA and receive request for proposal RFP

Get a ball-park budget within 48 hours

Bid defence and detailed proposal

Signature of contract

Kick-off meeting

Next steps to speed up your clinical journey.

Sign NDA and receive 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.

Speed up your clinical journey

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

Speed up your clinical journey