EU Phase I · First-in-Human · Early-Phase CRO

Clinical Research Unit
in Sofia, Bulgaria

First-in-Human (FIH), SASMIC, and innovative Phase I healthy volunteer or patient trials in our dedicated research unit – rapid turnaround with full EU GCP compliance.

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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.

Bioequivalence Bioavailability

Medical Devices Investigations

Vaccine Studies

CRO Services In Eastern Europe

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

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

Rapid Study Startup

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

European Union Regulatory Access

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

Dedicated Phase I Unit

Specialized clinical research unit for early-phase studies.

Healthy Volunteer Database

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

Full-Service CRO Support

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

Phase I Clinical Research Expertise

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

Flexible Support for Biotech Companies

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

Cost-Efficient Trial Operations

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

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OUR EXPERTISE

Clinical Research Expertise for Global Sponsor & Biotech Companies

Experienced Phase I infrastructure, competitive pricing, and multidisciplinary teams, all within the EU regulatory framework.

FULL-SERVICE CRO

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.

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PHASE I UNIT

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.

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FEASIBILITY & RECRUITMENT

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.

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EU REGULATORY

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.

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CLINICAL OPERATIONS

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.

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35+ Years

Clinical Research Experience

350+ Phase I Trials

Successfully Conducted

14,000+ Participants

In Our Clinical Studies

ICH-GCP

EU-Compliant Operations

Bulgaria & Eastern Europe

Strategic Access for Global Trials

Strategic Excellence in the EU: Clinical Trials with Global Validity

Experienced Phase I infrastructure, competitive pricing, and multidisciplinary teams – all within the EU regulatory framework.

Tell us about your clinical study.

We’ll let you know how we can support you all the way.

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Trusted by researchers. Committed to excellence.

FAQ

Frequently Asked Questions

Everything you need to know about running a clinical trial with Convex in Bulgaria.

01 What clinical research services can Convex provide for our study?

Convex offers a full spectrum of CRO services including Phase I-IV clinical trials, bioequivalence studies, first-in-human studies, medical device investigations, and vaccine trials — all under EU GCP standards within Bulgaria and Eastern Europe.

02 Do we need a local medical licence to start a pharmaceutical study in Bulgaria?

Convex can support sponsors through the local study startup process, including feasibility, regulatory coordination, ethics submissions, site preparation, and practical operational guidance for conducting the study in Bulgaria.

03 How can we make the clinical trial process flexible for our research company?

The clinical trial process can be adapted through tailored feasibility planning, flexible project management, dedicated clinical teams, and study-specific recruitment strategies aligned with the sponsor’s timeline and operational needs.

04 What makes Bulgaria a strategic choice for early-phase clinical trials?

Bulgaria offers EU regulatory validity, experienced clinical teams, competitive operational costs, strong patient and healthy volunteer recruitment potential, and access to Eastern European clinical research infrastructure.

05 How quickly can Convex activate a Phase I study?

Activation timelines depend on protocol complexity, regulatory requirements, documentation readiness, and recruitment scope. Convex supports fast feasibility review and coordinated startup planning to shorten the path to site readiness.

What clinical research services can Convex provide for our study?

1 of 5 questions

WHAT OUR CLIENTS SAY

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

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From the Research Unit

Convex Is Heading to World Vaccine Congress Europe 2026

September 2026

Clinical Research Unitin Sofia, Bulgaria