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OUR VACCINE CLINICAL TRIAL CAPABILITIES

Built for Vaccine Development


01

Phase I–III Vaccine Trials


Clinical trial capabilities spanning early-phase development through Phase III studies.

Vaccine vial in a clinical research laboratory

02

First-in-Human & Dose Escalation


Controlled dosing with intensive medical oversight and post-vaccination monitoring.

03

Healthy Volunteer Recruitment


Established volunteer database for efficient recruitment and participant retention (14 000+)

04

Safety & Reactogenicity


Monitoring of local and systemic reactions, adverse events, and safety signals.

05

Immunogenicity Assessments


Sample collection for antibody, neutralizing antibody, and other immune response endpoints.

Vaccine administration during a clinical study

06

Multiple Vaccine Platforms


Experience with mRNA, recombinant, conjugate, protein-based, and other vaccine technologies.

07

Inpatient & Outpatient Studies


Clinical facilities for intensive observation, scheduled visits, and long-term follow-up.

Preparation of a vaccine dose

08

EU Regulatory & GCP Expertise


Regulatory support and clinical trial conduct within the EU and ICH-GCP framework.

Clinical investigator

09


Integrated CRO & Clinical Site

CRO and clinical site teams working together throughout study delivery.

22+ Vaccine Clinical Trials

1,760+ Participants Enrolled

Phase I–III

19+ Years in Vaccine Research

OUR FIH CAPABILITIES

Built for First-in-Human Studies


01

Early phase medical team


PI – Clinical Pharmacology expert with 25+ years in clinical research.

11 sub-investigators in Cardiology, Neurology, Endocrinology, Intensive Care.

Clinical investigators reviewing a study together

02

24/7 Medical Safety


Dedicated critical care team & fully equipped monitoring unit

5 dedicated beds for continuous 24-hour vital signs monitoring.

03

Experienced Operations Team


7 Clinical research coordinators with 6+ years of experience.

14 clinical study nurses.

04

5 Recruitment Pathways


Multiple proven channels. One recruitment strategy.

Volunteer Database · Recruitment Partners · Referrals · Digital Outreach · Patient Networks

05

Dedicated Phase I Facility


15

beds dedicated for Phase I participants

Advanced Research Equipment

2 Hospital Partnerships

Emergency care access with dedicated medical transport

Dedicated Phase I clinical research facility

06

High Screening
Capacity


Up to 18
Study participants screened per day

07

Extended
In-House Stay


In-house accommodation for study participants for up to 15 consecutive days

Comfortable rooms for clinical research participants

08

24/7 Study
Operations


24 hours a day, 7 days a week clinical trial conduct at the site.

Clinical research team working in the laboratory

09


Fast FIH Start-Up

~35 days

regulatory approval

~10 days

to activate site & full team

Recruitment Ready

OUR FIH CAPABILITIES

Built for First-in-Human Studies


01

Expert Medical Leadership


PI – Clinical Pharmacology expert with 20+ years in clinical research.

9 sub-investigators in Cardiology, Neurology, Endocrinology, Allergology.

Clinical investigators reviewing a study together

02

24/7 Medical Safety


Dedicated critical care team with all equipment and drugs.

3 beds for 24-hour vital signs monitoring.

03

Experienced Operations Team


6 Clinical Research Coordinators with 5+ years of experience.

12 research-experienced nurses.

04

5 Recruitment Pathways


Multiple proven channels to recruit healthy volunteers and patients.

Database

HV Partner

Referrals

Online

Patients

05

Dedicated Phase I Facility


15

beds dedicated for Phase I participants

Up to 15

days in-house stay

3

beds for continuous monitoring

Dedicated Phase I clinical research facility

06

High Screening
Capacity


Up to 16 screenings per day. Includes sentinel patients enrollment.

07

Extended
In-House Stay


In-house stay of volunteers up to 15 days in the clinical research center.

Comfortable rooms for clinical research participants

08

24/7 Study
Operations


24 hours a day, 7 days a week clinical trial conduct at the center.

Clinical research team working in the laboratory

09


Fast FIH Start-Up

~35 days

regulatory approval

~10 days

to activate site & full team

Efficient.
Predictable.
Ready.

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