Medical writing
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.
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