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