Safety & Pharmacovigilance Services

Pharmacovigilance Partner of Choice

With our immense experience in clinical trial and post-marketing surveillance, we provide the latest safety and pharmacovigilance services, keeping abreast of global safety regulations. Our model encompasses robust processes and a global presence including a strong legacy throughout the Asia-Pacific region, so clients can better manage costs by outsourcing clinical trial safety and pharmacovigilance to a partner who understands the safety profile, costs and qualities of your product.

Our Services

George Clinical’s safety and pharmacovigilance experts ensure a patient’s well-being is paramount. Striking the right balance between benefit and risk, we can provide safety surveillance strategies for the sustenance of the medicinal product throughout the product lifecycle.

Clinical Study Safety Services
    Clinical Trial Safety Monitoring and Processing
    DSUR Preparation
    Safety Regulatory Reporting
Post-Marketing Safety Services
    ICSR Management
    Global Literature Surveillance
    Signal and Risk Management
    Pharmacovigilance System Master File (PSMF)
    Aggregate Report Preparation
    Medical Information Management
Medical Device Safety Services
    Device Vigilance – US FDA MDR, EU IVDR and EU MDR Compliance
    Post-marketing Surveillance
    Technical Document Preparation


Safety Surveillance

With end-to-end oversight of all key safety aspects of the product lifecycle, we emphasize, automate and streamline safety and pharmacovigilance processes ensuring a smooth transition in a product’s lifecycle as well as cost-effective management. By evaluating risk assessments based on each study phase, we help clients monitor a product safety profile that not only ensures patient safety but also enables ongoing evaluations and risk mitigation.

Safety Data Management

The George Clinical PV team leverages Oracle Argus, a comprehensive, highly scalable safety database for case management and reporting activities. This advanced platform not only consolidates a client’s clinical trial safety data into a single system, it eases integration with other toolsets your organization already relies upon. Machine learning and rules-based process automation greatly improve the speed of data-processing, lower monitoring costs and reduce manual input and the risk of poor data integrity. 

Local PV Regulations & Qualified Persons

As many developing nations are actively upgrading and implementing more stringent regulation for local safety monitoring, George Clinical helps clients to meet the mandatory requirement of a local presence via a qualified person with regional language proficiency by reducing operation cost with a balanced centralized and decentralized model. Our PV team includes local experts throughout the Asia-Pacific region.


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