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