A Full Suite of PV Services at Your Disposal

Tigermed’s pharmacovigilance experts have a sound understanding of global regulations and requirements. Combined with industry experience, they are well-suited to provide our clients access to a wide range of services. Being consistently quality-driven, globally oriented, and customer-focused has led to a proven track record of meeting or exceeding clients’ expectations.

Pharmacovigilance Operations for Clinical Trials

One-stop project management:

• PV system introduction
• Preparation: Review protocol; Review investigator branch; Review CRF; Draft safety management plan; database setup
• Case management
• Meetings such as safety review committee
• Draft/Review DSUR
• Draft/Review risk management plan

Pharmacovigilance Operations for Post Marketing

• Call center
• Literature search
• 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

Support Services Outsourcing

• Pharmacovigilance Audits
• Training
• Pharmacovigilance system outsourcing

Data Security

Tigermed’s SOP and relevant guides have been updated according to EU General Data Protection Regulation.

• Data confidentiality
• Data integrity
• Data availability and resilience

Procedures for regular testing, assessment and evaluation control objectives.

Project Experience

*As of Q1 2020