PHASE I CLINICAL RESEARCH CENTER

WE ARE FOCUSED ON THE CONDUCT OF EARLY PHASE CLINICAL TRIALS ON HEALTHY VOLUNTEERS AND PATIENTS

CONTRACT RESEARCH ORGANIZATION

WE CONDUCT MULTICENTER CLINICAL TRIALS IN VARIETY OF THERAPEUTIC FIELDS IN BULGARIA

Phase I Clinical Research Center

Convex early phase clinical research services combine clinical and operational expertise to accelerate the availability of therapies, diagnostics, and medical devices to humans. Convex early phase team collaborates with pharmaceutical, biotech, medical device, and food supplement companies and conducts a broad range of early phase studies. Our dedicated functional teams, including nursing, recruitment, nutrition, laboratory, and study coordination, enable us to execute high-intensity and procedure-heavy studies. In addition to having a great team of experts, we have at our disposal a state-of-the-art 15-bed research unit which can meet every early phase study protocol requirement.

Contract Research Organization

Convex CRO is a full-service Contract Research Organization (CRO) that is devoted to small to mid- size pharmaceutical, biologics, generics, vaccines, medical food and consumer healthcare companies with broad range of clinical research services, supporting phase I-IV drug and device development. We organize and conduct multi-site clinical trials in Bulgaria. Our experienced team will closely monitor your study following high quality standards and ensuring that data is collected properly. As full-service Contract Research Organization we can deliver the following services:

Clinical Research Organization CRO for multicenter clinical studies and Phase I Clinical Research Center CRC with pharmacology unit in Bulgaria, EUROPE 

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) 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 Bulgaria as CRO and Phase I 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 27 years as one of the leading CROs in 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 260 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 capabilies and expertize 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:

  • Phase I clinical studies
  • Pharmacokinetic and Pharmacodynamic studies (PK/PD)
  • Bioequivalence and Bioavailability studies (BE/BA)
  • Safety and Efficacy studies
  • Food Supplements studie
  • Medical devices studies
  • Vaccines studies

Our phase I unit was 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 can accommodate 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 achivements. For inquiries, please contact us at:

info@convex.bg