GlobalCRO 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.
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.
Study Start-up
- Site Feasibility and Qualification
- Site Contracting
- Project Plans and ISF
- Study Trainings
Clinical Study Management
- Project Oversight
- 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 Submission & Clinical Audit
- Clinical Audits
- Clinical Trial Application Submissions (CTIS)
- Regulatory Submissions to CA/IEC/IRB
- Data Protection
Pharmacovigilance
- Safety Events Reporting (SAE, SUSAR)
- Periodic Safety Reports (ASR, DSUR, PSUR)
- Safety Management Plan
- 24/7 Medical Monitoring
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
Information & Presentation Design
Translating complex information into clear and engaging visuals, helping understand the information effectively and quickly.
- Presentation Decks
- Diagrams
- Infographics
Fast & effective communicationWe use the following pre-validated software solutions in our daily practice.
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 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.
Dr. Martin Güttinger
Head Rare Disease & Medical, Gebro Pharma
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
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.
Pierre Tangermann
CEO, PerioTrap
“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
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.