Clinical trials
Committed to Excellence
MEDIC CENTRE s.r.o.(Ltd.) – company established in 2004 – provides large scale of services from conduction of clinical trials in Czech Republic offering ICH-GCP compliant services.
The founder and director of company, Jiri Chaloupecky MD, MBA has gained his extensive experience at international CROs . The whole team is highly familiar with the Czech Republic research and regulatory environment regarding II-IV phase international clinical trials, providing our customers with seamless and professional service.
Services
- Initiation conducting and closing of Clinical Trials
- Identification of suitable patient population
- Identification of suitable investigators and sites from our diabase
- Survey of the human and other resources needed for the study
- Protocol development
- Data Form compilation, typographic design
- Patient Information Sheet and Informed Consent compilation and translation
- Translation and adaptation of contracts and insurances
- Prepare the site for the study
- Set up of optimal contractual relationship between institutions, sponsors and investigators.
- Investigator’s Meeting Organization
- Initiation Visit, Monitoring Visits, Site closure, Query resolution
- Organization and tracking of the patient visits
- Completion of the CRF-s (paper based and electronic)
- Contact with the external participants (Radiology, Central labs, etc.)
- English to Czech, Czech to English translation of clinical research technical texts
- Processing all payments
- Co-ordination between all site related participants
- Regulatory and Ethics Approval
- Application submission and communication with Regulatory Authority (SÚKL), Multicentric Ethics Committees (MECs) and Local Ethics Committees (LECs)
- Tracking of the reports, handling comments of both authorities SUKL. MEC, LEC
- Full-scale regulatory and ethics approval procedures including Protocol Amendments Co-ordination of the SAE reporting