Global safety database "G2-MDS"

As a web based application, the G2-MDS provides our clients cost-effective and global standard adverse event management system for their products including drugs, devices, vaccines and combination products.


G2-MDS helps our clients in compliance with their global and local safety reporting obligations for their products. G2-MDS can handle safety information from all sources which include clinical studies, post marketing spontaneous report, safety related literature, nonclinical studies and media (including social media and websites). G2-MDS can be customized based on your business needs and special regulatory and safety reporting requirements. This system is E2B compliance and ready for global regulatory electronic submission.

 

The key innovative features and advantages of G2-MDS are:

 

  • Support the development of aggregate safety reports (e.g. PSUR, PBRER) for clinical and post-marketing surveillance
  • Easy and convenient AE/SAE case processing and case report distribution and submission with efficient and flexible workflows
  • Enables comprehensive and consistent medical safety review and company assessment process
  • Integrates with safety related document management capabilities
  • Ready to be customized based on your company’s clinical safety and pharmacovigilance business needs.

G2 Strengths

  • US Based
  • 24/7 coverage
  • Safety expertise
  • Cost effective
  • Teamwork
  • Compliance-focused
  • Quality-driven
  • Timely turn-around
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