Clinical Trials

Clinical Research Center and Phase 1 Unit

Convex Clinical Research Center was designed and built to address all the needs of the clinical research process. With over 40 experienced clinical investigators our Clinical research center with phase 1 unit offer an excellent approach to early phase research. Convex phase 1 unit is designed and built to address all the needs of the clinical research process and to ensure quality medical care and safety standards. Open 24/7, it is custom-designed facility and it is focused on pharmacokinetic studies on healthy volunteers. Our dedicated team of pharmacologists and early phase clinical research team perform phase 1 studies on patient population with a spectrum of diseases. Before each study is initiated we ensure all protocol requirements are followed and Convex Phase 1 unit is in compliance with the appropriate guidelines and regulations.

Phase 1 Unit

Phase 1 Unit

The Phase 1 unit, centrally located in Sofia city, allowing Convex dedicated staff to progress within the process of recruitment and retention of volunteers and to constantly develop a database of study subjects for multiple types of clinical trials. Our phase 1unit is constructed in a way to facilitate phase 1 researchers to conduct studies for a new drug or treatment in a small group of people and to evaluate its safety, determine a safe dosage range and/or identify side effects. Our expertise includes First-In-Man (FIM) studies, escalating dose studies, interaction studies, PK/PD studies, bioequivalence studies, and early phase studies. Convex clinical research institution with Phase 1 unit is designed and equipped to ensure compliance and safety.

Our Phase 1 Unit Facility include:

  • 15 beds with IV infusion capability
  • 5 clinical examination rooms
  • Sample processing room
  • Temperature / access-controlled drug storage area
  • Access-controlled sample storage room
  • Comfortable lounge
  • Kitchen and dining area
  • Archiving facility
  • Server room
  • Office space
  • Waiting room
  • Reception
Phase 1 Clinical Research Units

The safety and comfort of our clinical trial participants are of utmost importance

Convex research center provides emergency care specialists as well as specialized emergency medical transportation during treatment period for the save of our participants. In case of need, the clinical center maintains contract with an university hospital for unhindered and smooth emergency room accommodation and high-quality medical service.
We have created a relaxed and comfortable environment where our study subjects successfully complete their participation and meet new friends and medical professionals they could rely on in future.
A comfortable and clean environment, as well as maintaining of high-tech equipment, restful furniture and fun activities are elements for a full-comfort stay of our participants. Normally, our participants relax during their participation and gather pleasant stay memories. This approach allows us to complete our clinical projects without complications and constantly expand our healthy volunteer database on a monthly basis.
The food during study treatment periods is of essential importance. By exceeding our participants expectation, we successfully manage to maintain nutritional quality and quantity from a dietetic perspective and in compliance to all protocol requirements. To achieve all that we collaborate with a specialized catering company that meets all medical requirements and authorized by the Ministry of Health in Bulgaria.
Phase 1 Studies

Phase 1 Unit Europe
Early phase clinical trialDedicated clinical research institution specialized in the conduct of early phase clinical trials focused on healthy volunteers and specific patient population clinical studies.
State of the art equipmentThe research institution is equipped with all necessary equipment for the proper conduct of FIM, BE/BA, PK/PD studies.
Research quality serviceWe do make conscious decisions to commit to research requirements needed to build a sustainable research site. We constantly invest in quality systems to deliver quality data for the ultimate outcome of safe and effective new medical therapies. We commit daily to providing optimal care for study patients, following the regulations and self-regulating with the intent of quality improvement.
Clinical subject data baseConstantly increasing our study subject database consisting of large number of healthy volunteers and specific patient population. We are proud to make our study participants stay involved through-out the entire course of a studies as well as relaxed & happy.
Related clinical research servicesConvex provides end-to-end services for our biotech/pharma/or generic companies. Starting from clinical study design to the development of final study report. All services under one company including safety lab and PK analysis, biostatistical and data management, medical writing, project management, clinical monitoring, regulatory and consultation, IP packaging. Convex research organization successfully manage all steps of the way through the final results by an already proven and effective approch for every sponsor.