Integrated Capabilities

Pharmacovigilance

Industry-leading drug safety and pharmacovigilance solutions at a global level.

A Full Suite of PV Services at Your Disposal

With patient safety at the core of everything we do, Tigermed’s pharmacovigilance experts have a sound understanding of global regulations and requirements. Combined with industry experience, from clinical trials to the post-marketing, our PV teams are well-suited to provide our clients access to a wide range of services, and manage your safety and pharmacovigilance needs at any stage of product development including drug, medical device, vaccine and cosmetics.

To meet the ever-changing and diversified global clinical safety requirements, our PV and consulting team’s priority is to back you up with effective evaluation, industry-leading analysis, and customized solutions to minimize concerns and risks.

150+

Global customers in China, US, Europe and APAC

100+

Pharmacovigilance experts

10,000+/year

Case reports and management

Pharmacovigilance for Clinical Trials

  • Preparation: Review protocol; Review investigator branch; Review CRF; Draft safety management plan; database setup
  • Case management
  • Meeting support: IDMC, DSMB, project meetings, etc.
  • Draft/Review DSUR
  • Draft/Review risk management or risk control plan

Pharmacovigilance for Post-market Studies

  • Literature search & call center
  • Case management, including cases from Health Authority and oversea serious adverse reaction cases
  • Draft/Review PSUR
  • Draft Annual Report
  • Signal detection
  • Draft/Review risk management plan
  • Protocol support for Phase IV and RWS

Support Services Outsourcing

  • PV-related regulatory update and monitoring
  • Pharmacovigilance Audits
  • SOP writing services
  • Training services
  • Pharmacovigilance system outsourcing

Pharmacovigilance System Services

  • System setup and management
  • Data security and transfer
  • System maintenance
  • Audit and inspection support

Let's Connect for a Conversation