EU Phase I Clinical Research Unit in Sofia, Bulgaria | First-in-Human (FIH) & Early-Phase CRO

Accelerate First-in-Human (FIH), SAD/MAD, and complex Phase I healthy volunteer or patient trials in our dedicated inpatient unit, with rapid recruitment and ICH-GCP compliant operations.


35+ years

350+ Phase I trials

15-bed unit

14000 subjects completed

FIH / SAD / MAD Phase I execution

Dedicated inpatient capacity

Healthy volunteers & Patient cohorts

Rapid feasibility & recruitment support

ICH-GCP compliant

Audit-ready operations

Full-Service CRO in Eastern Europe: Accelerating Clinical Development


Decades of Regulatory Excellence and Human-Centric Clinical Trial Management.

Why Sponsors Choose Convex CRO

Accelerate Your Clinical Trial in Europe

Trusted CRO partner for Phase I studies with fast recruitment and cost-efficient EU operations.


Fast Patient Recruitment

Fast Patient Recruitment

Access to extensive healthy volunteer and patient recruitment networks across Bulgaria and Eastern Europe.

Rapid Study Startup

Rapid Study Startup

Accelerate study timelines with streamlined feasibility, ethics, and regulatory processes.

European Union Regulatory Access

European Union Regulatory Access

Conduct fully EU-compliant clinical trials under European regulatory standards.

Dedicated Phase I Unit

Dedicated Phase I Unit

Specialized clinical research unit for early-phase studies.

Healthy Volunteer Database

Healthy Volunteer Database

Access a continuously growing database of healthy volunteers for early-phase clinical trials.

Full-Service CRO Support

Full-Service CRO Support

Comprehensive clinical trial support from feasibility and regulatory submission to monitoring and final reporting.

Phase I Clinical Research Expertise

Phase I Clinical Research Expertise

Experienced in first-in-human, pharmacokinetic, safety, and tolerability studies.

Flexible Support for Biotech Companies

Flexible Support for Biotech Companies

Scalable clinical operations tailored for small and mid-sized biotech and pharmaceutical sponsors.

Cost-Efficient Trial Operations

Cost-Efficient Trial Operations

Reduce operational costs while maintaining high-quality clinical research execution.

OUR EXPERTISE


CLINICAL RESEARCH EXPERTISE FOR GLOBAL SPONSORS AND BIOTECH COMPANIES

Supporting Phase I–II clinical studies through dedicated infrastructure, integrated CRO services, patient recruitment expertise, and reliable clinical execution

Convex Phase I clinical research unit reception

01

End-to-End CRO Support – From Study Startup to Final Report

Convex provides comprehensive clinical trial support across study planning, regulatory coordination, site management, monitoring, patient recruitment, data collection, and Clinical Study Report delivery. Our experienced teams operate under strict ICH-GCP and EU standards to support reliable and efficient study execution.

02

Dedicated Phase I Infrastructure and Early-Phase Expertise

Convex Phase I facilities and experienced investigators support First-in-Human and early-phase programs through dedicated infrastructure, continuous medical oversight, and recruitment-focused clinical operations.

03

Rapid Feasibility and Strong Patient Recruitment

Accelerate study timelines through data-driven feasibility assessments and established recruitment capabilities across Bulgaria and Eastern Europe. Our site-centric recruitment approach supports faster enrolment and dependable study startup performance.

04

Regulatory Expertise and Efficient Study Startup

Our teams work closely with Bulgarian regulatory authorities and ethics committees to support compliant and efficient study approvals. We help sponsors navigate regulatory requirements with clear communication and practical operational guidance.

05

Dedicated Clinical Teams for Every Study

Each project is supported by experienced clinical investigators, coordinators, study nurses, recruitment specialists, and project leadership teams committed to efficient execution and reliable delivery throughout the study lifecycle.

35+ YearsClinical Research Experience

350+ Phase I TrialsSuccessfully Conducted

14,000+ ParticipantsIn Our Clinical Studies

ICH-GCPEU-Compliant Operations

Bulgaria & Eastern EuropeStrategic Access for Global Trials

Strategic Excellence in the EU: Clinical Trials with Global Validity


A Vogel
Allysta Pharmaceuticals
Ams Cro
Benfovir
Chiesi Pharmaceuticals
Cromsource Cro
Ergomed
Fortrea Cro
Fuics
Labcorp
Linical
Medpace
Neuceuticals
Pharvaris Biotech
Premier Research
Prn Pharmaceutical
Rho
World Wide Clinical Trials


Frequently Asked Questions


What clinical research services do we provide for your study?

  • Contract manager
  • Feasibility manager
  • Medical writers
  • Regulatory specialists
  • Subject recruitment specialist
  • Investigational team – PI, Sub-investigators, study nurses, study site coordinators,
  • Site manager
  • Project manager
  • Clinical research associates CRAs
  • Clinical trial associates CTAs
  • Data manager
  • Biostatistician
  • Accountant

Why do we see a return business from the same pharmaceutical companies or clinical trial sponsors over and over again?

  • Experienced team
  • High Recruitment capacity
  • Shorten timelines and milestones
  • Dedicated teams in variety of medical indications
  • Transparency in our work
  • Timely manner communication
  • End-to-end services for every project
  • Dedicated facilities/ available equipment
  • Competitive pricing

How do I make sure my clinical study would be feasible to Convex clinical research center with Phase I pharmacology unit?

Let us know about your request at: feasibilityteam@convex.bg  and we shall organize a TC to further discuss the progress of your study.

Testimonials


Convex has demonstrated strong expertise in regulatory support and study set-up, ensuring a smooth and efficient initiation process.

FUICS Development – Read more

I am pleased to offer my highest endorsement of Dr. Jeliazko Mirchev and his outstanding team at Convex.

PRN Pharmaceutical – Read more

We would be happy to conduct business with Convex again in the future.

Benfovir Therapeutics – Read more

We have had an excellent experience working with Convex from initial evaluation through full planning of a Phase 1 healthy volunteer study.

Allysta Pharmaceuticals – Read more

Throughout our experience and across the studies, the site was activated immediately after obtaining all needed approvals.

Pharvaris – Read more

Their team has demonstrated a high level of professionalism, excellent organizational capabilities, and strict adherence to timelines and regulatory requirements.

Chiesi – Read more

Study conduct, communication, and adherence to GCP standards were consistently of high quality, and timelines were managed efficiently.

A.Vogel – Read more

The study was conducted to our highest satisfaction.

Neurim Pharmaceuticals – Read more

We are pleased to highlight the flexibility and quick action that the project team at Convex demonstrated in response to our study needs.

Linical – Read more

CONVEX CRO team was highly professional and most efficient in the study regulatory approval, patient recruitment, and study conduct.

Nasus Pharma – Read more

Convex has demonstrated a high level of professionalism and efficiency communication.

R.S.NESS – Read more

CONVEX Team has been always supportive, proactive and flexible.

CROMSOURCE – Read more

Convex has continuously worked very reliable with high quality of work.

AMS – Read more

Convex provides excellent quality service in terms of qualified personnel and state-of-the art equipment.

Fortrea – Read more

The BioStudy was successfully completed, on time and on budget with excellent communication from Dr Mirchev and his team.

Neoceuticals – Read more

According to this long positive experience I can suggest Convex as ideal partner for the management of bioavailability/bioequivalence studies.

R&D Solutions – Read more