About Tigermed Development
Preclinical Clinical trial Related services Registration and Regulations
 
Our Life
Contact Us

X

Business Service

Subscribe to our email, focus on the latest products and promotional activities。
Location: Home > Our Services > > Pharmacovigilance

We provide Knowledge Process Outsourcing (KPO) services to pharmaceutical and healthcare companies. We delivers global standard and comprehensive KPO services through a robust US/China business operation model in areas of pharmacovigilance/drug safety to global and local clients with cost-optimized solution.

Service Scope
Comprehensive Case Management for English, Chinese, and Japanese case processing


• Safety management plan
• SAE form design SAE
• Triage and tracking all cases and prioritized classification of events
• Data entry, MedDRA and WHO-drug coding
• Narrative preparation and medical review
• Case follow-up
• Analysis of similar events (AOSE)
• Regulatory reporting worldwide
• Distribution of alert letters and expedited ICSRs to regulatory authorities, investigators, IRB/EC; and our clients


Literature AE search

 

We developed a unique sematic literature searching engine (www.aelse.info) for Literature AE search. Our tool can reduce labor intensive literature review screen; narrow down qualified article; assure broad search criteria; periodical update automatically; allow the client to setup own account to monitor safety profile from literature worldwide. Our services include

 

• Deliver periodic result
• HCP staff to screen the listing
• Provide full article service
• Literature case summary
• Provide case processing for all literature AE

Safety Database Services
The first CRO to host Argus safety database in-house in China.Our owned Chinese safety database for CFDA case processing and submission.In addition, our staff have the experience of working in various Safety Databases including ArisG, Argus, Oracle AERS, Clintrace etc.

• Configure Argus safety database based on sponsor requirement and specification
• Providing expert and cost effective solutions for all kinds of safety database systems and processes
• Argus safety database account setup, validation, and maintenance
• Safety database hosting
• Database queries and searches for safety evaluation and reporting
• Reconciliation of clinical and safety databases
• Aggregate line listing reports/ Periodic line listing
• Data mining from various Databases

Safety Assessment and Management Services

• Preparation and development of clinical protocol safety section, IB, ICF
• Safety Management Plan, Safety Monitoring Plan
• DMC/DSMB with Biometrics and clinical operation group
• Signal detection and safety evaluation
• Risk management strategies including preparation of EU RMP and US REMS
• PSUR (R1 and R2), PADER, ASR, DSUR preparation and review
• Preparation labelings of CCDS, USPI, and SmPc etc.
• Preparation and development of clinical protocol safety section
• Analysis and review of safety data arising from all phases of clinical trials
• Experts in regulatory services and support related to pharmacovigilance (Vol 10; FDA Guidance etc.)


PostmarketingSurvillance and Study


• Post Marketing Surveillance (PMS), PASS, registry, CV outcome studies
• Epidemiological literature searches and reviews
• Observational and non-observational study design
• Evaluation of background disease and event rates
• Safety signal detection and analysis suing health care database and regulatory database
• Translation between Chinese and English

• Medical writing and publication

 

Pharmacovigilance Consulting and Training

 

• Provide insight and overview of PV strategy
• Local drug safety/PV department setup and SOP development
• Review of the protocol’s AE reporting and safety monitoring section
• Review of Investigator Brochure and ICF drug safety section
• Safety training and presentation at investigator meeting

• On-site & off-site education/training for PV and safety databases

 

Safety Quality Assurance Services

 

• Mock PV inspections and inspection readiness for audit preparation
• Gap analysis
• Identifying and prioritizing improvements and CAPA support
• Site audit
• Quality compliance training and review