Milray JSC is a local contract research organization (CRO) providing a well-tested full-service for the conduct of your clinical trial in Bulgaria:

  • Study feasibility, site qualification and selection;
  • Drafting and negotiating contracts with Principal Investigators and Institutions;
  • Drafting contracts with the Local laboratory for safety investigations or central laboratory services;
  • Submission to the Independent Ethics Committee for its favorable opinion on the study protocol and any written information to be provided to the subjects involved in a given clinical trial;
  • Collection, translations and review of site-specific essential documents;
  • Preparing xml-files according EudraCT notification forms;
  • Applying the documentation to the Regulatory Authorities for review, acceptance and approval in accordance with the applicable regulatory and legal requirements);
  • Local project management;
  • Organising on a local level Study-specific meetings of Investigators teams;
  • Management of sample collection and shipment to local or central laboratories;
  • CRF and DCF processing;
  • Trial monitoring according to ICH GCP guidelines;
  • Timely reports to the Sponsor to provide regular up-dates on the trial conducted;
  • Total local accounting and financial services for the purposes of the ongoing trials.¬†

Our Expertise

Our Expertise

Partnerships

Partnerships

Locations

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