Taking WHO definition as a basis pharmacovigilance is a complex of actions connected with various types of activity and scientific investigations aimed at prevention, detection, assessment of adverse drug effects for the human body and other problems. In other words this is one of the new fields in the clinical pharmacology associated with supervision of pharmaceutical safety.
Pharmacovigilance agency detects complications caused by a new drug during its use in wide medical practice. In case of side effects detection the specialists of this organization are authorized to obligate pharmaceutical manufacturer to include all the information about application limitation, possible side effects into the leaflet of the drug and even stop its manufacture.
As per legislation all pharmaceutical companies must provide timely exchange of documentation between the pharmaceuticals manufacturers and the supervision authority. Pharmacovigilance is also aimed at informing the medical institutions about adverse side reactions for the pharmaceuticals. Russia entered WTO program on international monitoring of adverse consequences in 2007.
Services of Nadim CRO Company in the sphere of pharmaceuticals safety and the pharmacovigilance represent complex, universal decisions on active management of safety and risks during the whole life cycle of pharmaceuticals and medical products. Our group of specialists in various science fields offers complete set of services in the sphere of safety:
- competence in the sphere of therapy, advanced technologic and managerial experience;
- economically feasible decisions in the sphere of safety for small and middle scale companies with consideration of individual needs;
- flexible approach to delivery of functions associated with the safety to the third party organizations;
- physicians specializing in safety and having wide knowledge and experience, for medical supervision, inspections and signal detection (CIOMS IV and VIII);
- a group of qualified specialists on pharmacovigilance for pharmaceuticals registered by EU;
- up-to-date information about regulatory and legislator requirements of a specific country;
- reliable quality provision system;
- seminars and trainings on pharmacovigilance, consultations and professional training.
Starting with the early stages of the clinical research our reliable specialized decisions can provide compliance to safety requirements, from organization of the system till execution of express and consolidated reports.
Keeping individual safety reports is carried out with the help of our firm database or any system offered by the customer. Universal group of specialists will provide timely maintenance of data and processing of requests as per individual case safety reports (ICSR), serious adverse events (SAE), adverse drug reactions (ADR), pregnancy and other spontaneous clinical cases of concern. Herewith you will be guaranteed accuracy of coding and conformance to the clinical research bases.
Physician specialists of Nadim CRO Company on safety will conduct quality inspection of separate reports and simple line listings, give professional consultations (on planning of risk, signal detection), represent you in local regulatory bodies as qualified specialists of pharmacovigilance (QPPV) on behalf of your company — at any time at your convenience.
Personnel of the Document Presentation Department will provide presentation of the relevant express and periodic reporting complying with the requirements for individual safety reports (CIOMS I, MedWatch), herewith the documents submitted to regulatory bodies, ethical committees and expert advisory bodies organizations will comply with the requirements of a specific country. The specialists of Nadim CRO Company in the sphere of pharmacovigilance in EU will register your company into the database, will represent it and provide presentation of electronic reporting meeting E2B format into the European Medicines Agency (EMA) and EU regulatory bodies.
Preparation of safety reports (description of cases, annual safety reports (ASR), safety-related sections of annual reports to applications for registration or research of new pharmaceuticals, investigator's brochures, periodic safety update reports (PSUR), including Development Safety Update Report (DSUR), clinical assessment of products, safety certificates etc.) is carried out in accordance with the applicable regulatory and legislatory standards of medical documentation.
We will render assistance in management of activity of Data and Safety Monitoring Board (DSMB, DMC, committee for result assessment etc.), including assistance in execution and control of protocol with participation of statistic specialists and members of the supervisory board, in disclosure of the randomization code and presentation of data from the safety base.
If you registered pharmaceuticals in Europe we will render services on pharmacovigilance, promoting continuous control of quality, safety and efficiency of the sold products.
- Pharmacoeconomic studies
- Development of medical documentation
- Medical statistics and translations