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G2 Bio Pharma Services Inc. (“ G2-BPS”) is a global expert service company focusing on clinical trials medical and safety monitoring, post-marketing surveillance and pharmacovigilance (PV), real world medical safety and disease data management, healthcare product safety risk mitigation, and regulatory (IND/NDA) preparation and submission.
We serve biotech and pharma companies, contract research organizations (CROs), and healthcare institutions and organization around the world.
With our 24/7 global expert service network equipped with innovative safety data processing and risk monitoring tools, we provide our clients reliable, regulatory-compliance, high-quality, cost-effective expert consultation and team services on a global platform (USA/Princeton, Boston; China/Beijing Guangzhou, Hong Kong, Taipei; Japan/Tokyo).
G2 expert team offers a wide range and high-standard safety services to assist clients in enhancing their safety procedures, operations.
G2 offers in-depth safety service to support CRO’s existing team to maintain regulatory compliance and minimize safety-related risks.
G2 also offer (special services) to support our clients special requirements
Safety Tasks are not all the same, so our wide range of skilled team members are ready to provide tailored solutions to your company. We specialize in completing specific safety tasks no matter how complex.
Examples:
• Labs/ECG data summary for safety monitoring and signal detection
• Medical impact analysis for late SAE reports
• Published literature review and summary
With a stable of seasoned professionals ranging from safety physicians to database managers, we are prepared to assist in all stages of trials and research.
Examples:
• Full clinical safety services for clinical trials including SAE processing
• Medical safety monitoring
• Signal detection
• DSUR
• IB update
• CSR safety section
Our professionals are trained in the latest regulations and processes, which allows them to seamlessly assist your existing safety team achieve safety goals.
We provide experienced medical safety professionals to work alongside your safety team in order to meet your special safety evaluation needs.
Examples:
• G2 medical reviewers working in our clients’ ICSR processing teams,
• G2 medical scientific writer working with our clients’ safety physicians on DSURs or PBRERs
Safety DB
Real world experience study
PV DM/AI
Post-marketing data apps