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  • Pharmacovigilance

    For ensuring drug safety, it is essential to assess precisely the drug risks and take corresponding measures, which requires safety management professionals to collect, detect, assess, monitor and prevent adverse reactions during drug development to drug post-marketing.

Pharmacovigilance and Call Center

By establishing an Electronic Data Integration (EDI) call center, it creates a communication channel between companies and clients that will save the R&D costs and assist to monitor safety related risks of drugs/medical devices, promote public health, and provide clients a variety of high-quality, efficient services.

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    CSC pharmacovigilance team are composed of globalized and high-level experienced, competent members with capacities of multilanguage skills, e.g., English, Japanese, Korean besides Chinese. CSC also has a comprehensive PV training system and a series of PV SOPs complying with regulatory requirements, and constantly pay an attention to the updates of pharmacovigilance laws and regulations and regularly organize interactions and discussion with the PV industrial specialists and regulators to ensure that the level of drug safety specialists on mastering pharmacovigilance laws and knowledge reach the international standards.
    With comprehensive understanding of regulations of multiple countries such as China, the United States, Japan, Australia, New Zealand, Qatar and the EMA, the pharmacovigilance team have undertaken hundreds of domestic and international projects, involving in the therapeutic medical fields of oncology, respiratory, rheumatologically immunity, preventive health care, ophthalmology, proctology, endocrinology and so on with drug phase I-IV and BE trials, investigator-initiated clinical trials as well as medical devices and post-market clinical projects.
    In order to meet the sponsor/partner’s requirements, the whole team could make full response, spare no effort and proactively cooperate to complete various tasks. Our optimized process, comprehensive skills and outstanding PV staffs could provide high-quality services for sponsors, and ensure that the sponsor's pharmacovigilance business will occupy a competitive position in the industry.

    We can provide bellowing services but not limited:

    Intensive drug monitoring

    Drug safety information management

    Individual case safety report

    Medical review

    Literature searching and processing

    Signal detection and management

    Periodic safety update reports

    Development Safety Update Reports

    Risk management plans development

    Safety Information Summary Analysis and Report

    Construction and maintenance of pharmacovigilance system

    Pharmacovigilance Consultancy

    Pharmacovigilance Database

    • Call Center

      By establishing an Electronic Data Integration (EDI) call center, CSC PV team is helpful for our clients to create a communication channel with patients , which may save the R&D costs and assist to guard against relevant risks of drugs/medical devices, promoting public health.

    Call center has a unified service specification and management system, equipped with professional, standardized, personalized services, and through technical means to reduce company business operating costs. It can flexibly provide a variety of services according to clients’ needs or requirements, and be able to handle a large volume of calls at the same time with recording and storage of incoming all information via calls. Such comprehensive and accurate services may not only improve an efficiency of safety information management, but reduce enterprises’ working loads on regulatory PV requirements. Moreover, the Call center has set up stable underlying architecture, reliant lines and safety alerts system.

    Our team is expertise at the following services:

    Subject visit reminder

    Subject medication reminder

    Product safety information collection

    Product quality complaint

    Subject screening and recruitment

    Pre-sales/after-sales service

    Questionnaire

    FAQ

    Other information collection

    KBM

    User information management

    Project Management

    Data analysis and reporting