Safety & Pharmacovigilance Services


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.

 

Pharmacovigilance Partner of Choice

Our established process and capabilities managing medicinal product safety expands from the developmental stage to continue throughout the post-marketing stage. 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 partner who understands the safety profile, costs and qualities of your product. Clients can expect a focus on quality and efficiency as required throughout a product lifecycle.


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
  • Clinical Trial Safety Processing
  • DSUR Preparation
  • Safety Regulatory Reporting


Post-Marketing Safety Services
  • ICSR Management
  • Global Literature Surveillance
  • Signal Management
  • Risk Management
  • Pharmacovigilance System Master File (PSMF)
  • Aggregate Report Preparation– PSUR, PBRER, PADER
  • 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

George Clinical offers end-to-end oversight of all key safety aspects of product lifecycle.

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 in China, Malaysia, Taiwan, Hong Kong, Indonesia, Philippines, India, South Korea, Australia, Singapore and elsewhere.

Global Reach 

George Clinical has grown rapidly across the Asia-Pacific region and continues to develop and enhance operations around the globe. Headquartered in Sydney, Australia, George Clinical has operational hubs in China, India, Hong Kong, South Korea, Taiwan, Malaysia, Philippines, Japan, Singapore, New Zealand, United Kingdom, Czech Republic and the United States of America.

Add George Clinical to your network