Gynekologie

Mám svůj životní styl, plány do budoucna. Chci mít jistotu, že vše zvládnu dle svých představ. Nečekám na nemoc, jsem zvědavá, ptám se. To je normální.

Clinical Trials

MEDIC CENTRE s.r.o.(Ltd.) - company established in 2004 - provides the 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


First contact please to : clinicalservices@email.cz