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.

Strategic Clinical Solutions for the Global Biotech Sector: We Offer, We Deliver.


Comprehensive End-to-End CRO Services: From Protocol to Final Report

Leverage decades of industry-leading expertise with our full-service CRO solutions, seamlessly managing your study from initial protocol design to the final Clinical Study Report (CSR). We ensure uncompromising ICH-GCP compliance to deliver high-fidelity data that accelerates your path to global market approval

Rapid Feasibility & High-Volume Patient Recruitment under ICH-GCP Standards

Accelerate your study timelines with our data-driven feasibility assessments and proven access to a vast, diverse patient population. Our site-centric recruitment strategies ensure rapid enrolment targets are met under strict ICH-GCP standards, maintaining the highest levels of data integrity and subject safety.

Expert Regulatory Guidance & Accelerated Study Approvals

Navigate complex regulatory landscapes with confidence through our proactive synergy with the National Drug Agency and Central Ethics Committees. We leverage deep institutional knowledge to deliver accelerated study start-up and streamlined approvals, ensuring your project remains compliant and on schedule

Transparent & Adaptive Operations: Integrated Phase I Unit and CRO Services

Streamline your early-phase development by integrating our specialized 15-bed Phase I unit with comprehensive CRO management under a single, transparent operational structure. This “under one roof” synergy allows for real-time data access and adaptive study pivots, significantly reducing overhead while maintaining uncompromising safety and precision

clinical trials phase 1

Infrastructure Excellence: Our State-of-the-Art 15-Bed Phase I Clinical Unit

Our purpose-built, 15-bed clinical facility is equipped with the latest medical monitoring technology to support complex Phase I and Bioequivalence studies with surgical precision. Operating 24/7 under stringent safety protocols, our unit provides a controlled, high-performance environment designed to ensure subject welfare and the generation of clean, audit-ready data.

35 Years of Clinical Excellence:
Trusted Global Expertise


650+

Successful Studies Phase I – III

35 Years of Expertise

14,000+

Enrolled Participants

Patient-Centric Approach

410+

Global Sponsors

US, EU & Asia Reach

With over 35 years of experience, we deliver the precision and integrity required for world-class clinical research. Working in seamless synergy with the National Drug Agency and the Central Ethics Committee, we ensure uncompromising compliance with the highest global regulatory standards.

Global Footprint

Trusted partner for biotech & pharma leaders across the U.S., Western Europe, Israel, and China.

Proven Data Integrity

Consistently generating the high-quality clinical data essential for global regulatory success.

Strategic Partnerships

We don’t just execute trials; we build enduring collaborations based on reliability and results.

Strategic Excellence in the EU: Clinical Trials with Global Validity


Phase 1 Unit For Clinical Research On Healthy Volunteers –
Phase I Studies, Bioequivalence And Bioavailability Studies
In Bulgaria, Eastern Europe


Clinical Pharmacology Center With Phase I Unit Eastern Europe Bulgaria

Convex Ltd. is a private, family owned company with two main business divisions – clinical research management (CRO) and clinical research conduct (CRC). Convex CRO is a full-service Contract Research Organization (CRO in Bulgaria) that is devoted to small to mid- size pharmaceutical, biotechnology, generics, vaccines and nutrition companies with broad range of clinical research services in support of phase I to phase IV investigational drug and device development. Operating in Eastern Europe, Bulgaria as CRO and Phase 1 clinical research center, we provide hands-on versatility and flexibility, while adhering to the highest standards and providing quality service. Our smaller overhead, company structure and strategy allow for a leaner budget. For the past 30 years as one of the leading CROs in Eastern Europe, Bulgaria we managed to create a network of over 72 investigational sites including university and public hospitals, diagnostic consulting and medical and other private medical institutions.

We have extensive experience in conducting multicenter clinical trials in the following therapeutic areas: Oncology, Cardiology, Allergology, Pulmonology, Dermatology, Neurology, Endocrinology, Gastroenterology, Ophthalmology, Rheumatology, Gynecology, Rare diseases and Psychiatry. Convex CRO manages the entire clinical trial process. We have successfully completed over 280 clinical studies in given timelines and budget while focusing on integrity, transparency and excellence. Our capabilities cover A – Z clinical research services starting from: feasibility assessment, study teams and sites selection, budget management, contracts negotiation, medical writing, regulatory activities, investigator meeting organization, study startup support, study team training, project management, subjects recruitment, sites management, vendors management, clinical monitoring, safety reporting, auditing, data management, biostatistics, final report development and scientific consulting. Convex CRC is a clinical research center with a built-in phase I unit in which we have the capabilities and expertise to conduct clinical trials in early phases, as well as other types of studies.

The Clinical Research Center with pharmacology unit is focused on the conduct of single-center clinical trials on healthy volunteers and specific patient populations:

  • First-in-man studies (FIM – healthy volunteers – single and multiple ascending dose studies)
  • Phase 1 clinical studies (healthy volunteers and specific patient population)
  • Phase II, III clinical trials (specific patient population)
  • Pharmacokinetic and Pharmacodynamic studies (PK/PD – healthy and patient population: drug-drug/ drug-food interaction studies)
  • Bioequivalence and Bioavailability studies (BE/BA) (healthy volunteers and specific patient population)
  • Safety and Efficacy studies
  • Food Supplements studies
  • Medical devices studies
  • Vaccines studies

Our phase 1 unit is designed specifically for early-phase clinical studies, following the guidelines of the UK Medicines and Healthcare Products Regulatory Agency and the ICH-GCP. The stationary part of the unit accommodates 15 subjects for overnight stay. All essential facilities for storing study drugs, maintaining and storing study documentation, managing biological samples and handling emergency situations are available inside the unit. Specimens are seamlessly transferred for analysis to preferred bioanalytical lab or safety lab of your choice. Recruitment of subjects is facilitated significantly by the fact that the Clinical Research Center is strategically situated within a large metropolitan area, with access to population of over 2.5 million people. Our strongly developed network of referring General Practitioners and the availability of proactive recruitment specialists also brings a great benefit to successful recruiting achievements.

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Hey, tell us about your clinical study and we’ll let you know how we can support you all the way

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.