Medical writing

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CRO Medical Development Agency offers services in medical writing for the appliance to conduct clinical trials phase I-IV.

CRO Medical Development Agency offers services in medical writing for the appliance to conduct clinical trials phase I-IV.

Services for the organization and conduct of drug safety monitoring (pharmacovigilance) include, but are not limited to:

Establishing and ensuring proper functioning of the pharmacovigilance system in the company;

Collection, processing and transmission to the head office of the company and to Roszdravnadzor of information about adverse events in the medical use of drugs of the company;

Preparation and transmission to Roszdravnadzor of periodic safety reports (PSUR) and reports of serious adverse events (CIOMS);

Conducting pharmacovigilance trainings for company employees, including trainings for medical representatives;

Compliance with corporate requirements and procedures in the field of pharmacovigilance, SOP support of the company.

Development of pharmacovigilance system Master file;

The development of the System and the risk management Plan (RMP);

Monitoring of Internet sources and literature, search for information on the safety and effectiveness of drugs;

Development of Periodic safety reports (of POLLS);

Development of reports on the safety of the drug being developed (DSUR);

Submission of urgent and periodic reports to regulatory authorities;

Conducting post-Registration security studies (PRS);

Development and conduct of pharmacovigilance trainings;

Development of SOP in accordance with the requirements of counterparties and regulatory authorities.

You need to know
Useful information on the legal basis for the circulation of medicines in the Russian Federation.
Useful information
Useful information
Useful information on the legal basis for the circulation of medicines in the Russian Federation.
Our team
Our team
Medical Development Agency specialists are not just experienced managers who have a solid background of knowledge, skills and successfully implemented projects. It is also a friendly, cohesive team that ensures a high level of efficiency of our work and the competitiveness of the company in the market.
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