Post approval research, post marketing studies, phase IV trials, patient registries in Russia
Medical Development Agency has a broad and deep experience in the field of post-approval studies in Russia, combined with a solid base in the late-stage clinical trials management.
Our clinical research experience ensures collaboration and integration from pre-approval to post-approval. We provide a custom-tailored process to meet local regulatory requirements. Our operating procedures are designed for the post-approval setting.
Early Post Approval Planning in Russia
We help our clients protect their investment with early post-approval planning
- Fulfill regulatory commitments
- Develop new indications, delivery mechanisms and patent extensions with late-stage trials
- Explore off-label usage with investigator-initiated trials
- Assess long-term safety and determine optimal use with observational studies
Medical Communications
Our team provides high-quality, customizable programs that communicate essential product information to customers quickly and cost-effectively
Pharmacovigilance
Our company provides a full range of services in the sphere of drug safety and pharmacovigilance organization in the company in Russian Federation:
- Design development and implementation of the safety programs in the company that comply with regulatory guidelines and that protect your patients study participants, and reputation;
- Real-time collection and processing of the adverse events information and its transmission to the Head Office of your company and to the Roszdravnadzor;
- Preparation and submission of periodic safety update reports (PSURs) and suspect adverse reaction reports (CIOMS);
- Training organization on pharmacovigilance for the employees of your company and for the medical representatives;
- Compliance with corporate requirements and procedures in the field of pharmavigilance, standart operating procedure (SOP) support.
Late Stage Research
Our project managers provide quality deliverables on time and on budget, resulting in effective post-approval programs, including Phase IV trials
- Phase IV studies
- Expanded Market access programs
- Post-approval studies
- Investigator-initiated studies
- Registries (all types including patient, disease, product and pregnancy)
- Post-authorization safety studies (PASS)
- Comparative effectiveness research
Epidemiology & Health Economics & Research Outcomes
Medical Development Agency takes a collaborative, customized approach to delivering epidemiologic and health outcomes data, information and knowledge that allows you to:
- Make more informed decisions with greater control of your data
- Demonstrate your product’s safety, effectiveness and quality with a strong evidence basis
- Gain the necessary insight to optimize treatment advice and realize your product’s greatest value
Medical Development Agency provides program and study design, protocol development, consultation, epidemiologic and statistical analysis, report writing and publication services
- Observational and epidemiological studies
- Pharmacoeconomics and health outcomes studies
Systematic and structured literature reviews
Our HE&OR managers (project team from our Health Economics group) routinely conduct high-quality literature reviews to help our clients gain insights to inform and develop market access strategies Projects include:
- Disease definitions, etiology and diagnosis;
- Epidemiologic, humanistic, and economic burden of a disease;
- Treatment guidelines and patterns in clinical practice;
- Clinical effectiveness of comparator treatments;
- Cost-effectiveness of comparator treatments.
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