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.