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Is a part of ZM CRO Group ZM CRO GROUP 2017

Team Member Medical Doctors Biotech Specialists Pharma Specialists Project Managers Clinical and Prost-Marketing Research Professionals Qualified Person Responsible for Pharmacovigilance Medical Monitors Team Advantages Profound theoretical and with profound academic background and hands-on clinical research and pharmacovigilance Advanced language skills (Russian, English, Chinese) Undergo continuous professional growth and upgrade qualification ZM CRO GROUP 2017

Boutique CRO flexibility Transcontinental corporation global experience Deep knowledge and Creative solutions Full-service CRO capabilities and Methods diversity 24/7 Availability ZM CRO GROUP 2017

Pharmacovigilance in clinical trials Pharmacovigilance and post-marketing surveillance Audit Trainings for employees

Pharmacovigilance in clinical trials Safety database hosting and maintenance Development and input on study documentation 24/7 Medical Monitoring Medical Coding with MedDRA, WHO-Drug dictionaries and coding consistency review Study sites support Development and updating of Safety Management Plan Individual Case Safety Reports (ICSR) processing and submission CRF & Safety line-listings medical and safety review Input on Clinical Study Report development ZM CRO GROUP 2017

Pharmacovigilance and post-marketing surveillance Pharmacovigilance system development (Pharmacovigilance system master file) per EAEU and ICH recommendations Pharmacovigilance quality assurance and control systems development and maintenance (SOP, Working Instructions, Forms, Listings, etc.) Local Qualified Person Responsible for Pharmacovigilance functions ICSR and spontaneous reports registration, validation, entering in database, medical evaluation and submission to regulatory authorities Safety database maintenance for medicinal products and trials Literature and Internet search for spontaneous reports and signals Periodic Safety Update Report development and submission (PSUR) per EAEU and ICH requirements Risk Management Plan (RMP) updating and development per EAEU and ICH requirements ZM CRO GROUP 2017

Trainings of Employees Trainings and seminars at 3M Veritas or Client site Online trainings in a format of webinars and teleconferences Audit Existing pharmacovigilance system audit Contribution to CAPA Plan ZM CRO GROUP 2017

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