Expertise
We conduct clinical trials in accordance with ICH-GCP guidance, local laws requirements, European directives and legislation.
Working with Milray JSC you could rely on a professional and responsive partner between sponsors, regulatory authorities, independent ethics committees, subcontractors and investigators.
The company Milray JSC engage is in controlling clinical researches under the provisions of the Bulgarian Law of Pharmaceutical Products in Human Medicine Act and in medicine activity under the Medical Institutions Act and trade activities with pharmaceulicals and medical products and advertising services.
The main objective is organizing and coordinating of clinical trials conducting. Clinical trial is any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product/s/ and/or to study an investigational product/s/ with the object of ascertaining its safety and/or efficacy.
In details that means:
- Preparing contracts to the investigators and site of investigation /hospitals/
- Submission to the Independent Ethics Committee for its approval /favourable opinion for the trial protocol and any written information to be provided to the subjects involved in a clinical trial
- Applying the documentation to the Regulatory Authorities for review, acceptance and permission (as required by the applicable regulatory and legal requirements) to begin the trials
- Trial monitoring to verify that
- The rights and well-being of human subjects are protected
- The reported trial data are accurate, complete and verifiable from source documentation
- The conduct of the trial is in compliance with currently approved protocol, with Good Clinical Practice and with the applicable regulatory requirements.
