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Convex Phase I Clinical Research Center

Dedicated clinical research center for early drug development in healthy subjects and specific patient population

Convex Phase I Clinical Research Center

Convex CRO and Phase I clinical research center have the capabilies and expertize to conduct clinical trials in healthy volunteers and patient population. We are focused on single-center clinical trials including:
- Phase I clinical studies
- Pharmacokinetic and Pharmacodynamic studies (PK/PD)
- Bioequivalence and Bioavailability studies (BE/BA)
- Safety and Efficacy studies
- Food Supplements studies
- Medical devices studies
- Vaccines studies

Phase I unit is designed in accordance to MHRA and ICH-GCP standards and daily maintain a large database of study subjects. It is fully equipped to meet any early phase clinical study:

- 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

- Monitoring equipment, including ECGs, e-BP monitors, ECG-Holter

- 5 Infusion chairs

- Medical emergency equipment

- High resolution imaging ultrasound system

- 24h ECG and Vital signs monitoring systems

- Autoclaves

- Refrigerated and ambient centrifuges

- Medical refrigerator and freezers supporting -20°C, -35°C, -70°C, -80°C

- Real time temperature logging system with integrated alarm

- Audio study nurse station

- Synchronized clock system

- Pull-cord and push-button emergency devices

- 24/7 extensive hi-tech external/internal security monitoring and video surveillance system

- Alarm system including an intrusion detection system and panic button

- Fire alarm system connected to the central Fire Safety and Civil Protection unit

- Standby generator in the event of power failure, covering the whole premises of the CRC for 48h

- Clinical safety Lab

- CT, MRI, micro CT, X-ray 

For additional Information, please contact us at jeliazko@convex.bg


Demographic Data

  • Start year clinical research1992
  • Phases of clinical studiesPhase I, Phase II, Phase III
  • Types of studiesBiologics, Drugs, Medical Devices, Nutraceuticals, Vaccines
  • PopulationsAdult 18-64 yrs, Senior 65 yrs and over
  • Type of siteFreestanding
  • # of employees involved in research17
  • # of investigators28
  • Number of studies last year22
  • Days openMonday, Tuesday, Wednesday, Thursday, Friday, Saturday, Sunday
  • Extended office hoursYes
  • Overnight facilitiesYes
  • Dry iceYes
  • Blinded pharmacistYes
  • Dedicated monitoring spaceYes
  • Internet access for the monitorYes
  • Onsite laboratoryYes
  • Central laboratoryYes
  • Infusion capabilityYes
  • Shipping optionsFedEx, UPS, DHL, Other
  • Contact for regulatory documentsLilyana Mircheva
  • Regulatory phone number+359884650255
  • # of days to turn around regulatory documents4
  • Type of IRB used by this siteCentral, Local
  • How often does your local IRB meet?Weekly
  • Appropriate storage facilities for productYes
  • Able to appropriately store Schedule II drugsYes
  • # days to turn around budget and contract5 days