Index

Services

MEDART was founded in 2006, since than we have been expanding the range of services each year.The large extent of our services and flexibility is resulting in the increase number of new projects.

We always adjust MEDART services to Client’s individual needs.

We offer our Clients the initial assessment of individual needs and assistance in designing projects in order to increase their effectiveness. Each project obtains an experienced manager, who supervises its scope, quality, budget and timelines as well as takes care of the complete range of services.

In order to provide our Clients with the best required service we cooperate with other established CROs throughout Europe and India. MEDART can offer Clients the coordination of clinical trial performed in selected European countries and India.

MEDART specializes in:

  • The selection of high quality clinical sites, confirmed by audits and investigators’ recruitment
  • Conducting the study feasibility process
  • Pre-study qualification visits and checking the capabilities and equipment necessary for the center to perform the study
  • The negotiation of contracts with investigators and institutions.
  • Preparing the content of patient leaflets, customizing it to Polish requirements and compiling other information materials related to registration documentation
  • The preparation and submission of clinical documentation to the Ethics Committee and Regulatory Authority.
  • Piloting the process of obtaining approval for clinical trial of Regulatory Authority and Ethics Committee.
  • The organization of Investigators’ Meetings
  • Making visits to initiate clinical trial
  • Site Teams trainings on GCP and particular study requirements
  • Monitoring the progress in scientific research
  • Planning strategies for efficient patients enrollment and retention at clinical trial
  • Reporting SUSARs to required institutions and research centers
  • Local cooperation with other companies involved in the clinical trial such as companies providing equipment, IP, processes, tools
  • Site payments
  • Preparing reports on the course of the study
  • Updating the documentation in the course of a clinical trial
  • Carrying out the process of closing the study centers, and submitting appropriate notifications to the Ethical Committee and Regulatory Authority
  • Investigational site audits (in Poland as well as in other countries)
  • Quality management
  • Archiving of clinical trial data
  • Pharmacovigilance