PHASE I CLINICAL RESEARCH UNIT AND CRO – PHARMACOKINETIC CLINICAL STUDY EXPERTS

Convex CRO provides integrated and flexible clinical research solutions designed specifically to support smaller biotech and generic companies to move forward to the development of their medicinal products. We have unique expertise to covers the entire development path (Phase 1 to Phase 3) in clinical trial design, organization and supervision. Early Phase CRO and Clinical Phase I Pharmacology Unit combine a variety of expertize into the development of Phase I trials, Bioequivalence and bioavailability study and wide gamma of pharmacokinetic and pharmacodynamic studies. We operate in Eastern Europe, Sofia, Bulgaria. Our phase I CRO provide full clinical and operational services. Convex early phase clinical research team is partnering along with pharmaceutical, biotech, medical device, and food supplement companies. Our CRO conduct a broad range of early phase studies including FIH, Phase I studies, PK, PD, BE, BA studies on healthy volunteers and patients. Our CRO experts, include: key opinion leaders, clinical investigators with extensive clinical research background, study nurses, clinical study coordinators, recruitment specialists, lab technicians, clinical trial managers, data managers and biostatisticians, CRAs and CTAs. All that 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 pharmacology research unit which can meet any early phase clinical study protocol requirements for: single center study, bioequivalence study, bioavailability study, phase I study, vaccine study, food supplement study and medical device study. Convex is a full services CRO supporting pharmaceutical industry in the conduct of a variety of research programmes by covering A-Z services for their study related requirements. We support research and development companies in Study start-up, Medical writing (protocol/ICF/subject specific clinical subject documentation/ final study report development), Clinical trial regulatory services (consultation and submission to RA/CEC/EC), IMP labeling and packaging, Investigator meeting organization, Contracting, Healthy subject/patient recruitment, Clinical trial operations services, Clinical monitoring, Safety reporting, Project Management, PK analysis of blood samples, Data Management and Biostatistics (electronic or paper-based CRF), eCTD formatting of study documentation. We are a full service vendor dedicated to the conduct of variety of single center clinical trials.

First-in-human

Phase 1 Studies

Phase 2-4 studies

Food Supplements

Bioequivalence bioavailability

Medical devices investigations

Vaccine Studies

CRO Services in Eastern Europe

CRO IN EASTERN EUROPE BULGARIA – MULTICENTER CLINICAL TRAILS

Convex CRO located in Eastern Europe, Bulgaria 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:

Feasibility and site selection

Medical writing

Regulatory services

Contract management

Project management

Clinical monitoring

Biostatistics and data management

Bioanalytical services

PHASE 1 UNIT FOR CLINICAL RESEARCH ON HEALTHY VOLUNTEERS – PHASE I STUDIES, BIOEQUIVALENCE AND BIOAVAILABILITY STUDIES IN BULGARIA, EASTERN 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 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 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:

• 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.