G2 BioPharma Services
G2 BioPharma Services Inc. is a global expert service platform with locations in the USA, Japan, Hong Kong, and Taipei. The company focuses on IND application, First-in-Human (FIH) trials, and global standards medical safety risk management in clinical trials and post-marketing settings. They serve biotech and pharma companies, CROs, and healthcare institutions worldwide, providing comprehensive and customized medical safety and PV expert services, including support for IND applications, global clinical trials, NDA/BLA applications, and post-marketing PV services. Their mission is to support clients in managing clinical safety, regulatory compliance, and safety data analysis with a team of seasoned professionals.
Industries
Nr. of Employees
small (1-50)
G2 BioPharma Services
Services
Consulting on IND/NDA/BLA submission components, safety strategies for submissions, and regulatory communication.
Study design input, medical monitoring, safety monitoring, SAE processing, and on-site/site support for first-in-human trials.
Medical monitoring and oversight, DSMB/DMC support, global SAE/SUSAR processing, and aggregate safety reporting across multi-regional trials.
Post-approval PV workflows including ICSR processing, literature surveillance, signal management, and periodic safety reports.
Support for CROs including PV system/database setup, staff training, SOP development, audit preparation, and embedding expert personnel.
Design and deployment of global safety databases and data review tools to support AE/SAE processing and regulatory submissions.
Consulting on IND/NDA/BLA submission components, safety strategies for submissions, and regulatory communication.
Study design input, medical monitoring, safety monitoring, SAE processing, and on-site/site support for first-in-human trials.
Medical monitoring and oversight, DSMB/DMC support, global SAE/SUSAR processing, and aggregate safety reporting across multi-regional trials.
Post-approval PV workflows including ICSR processing, literature surveillance, signal management, and periodic safety reports.
Support for CROs including PV system/database setup, staff training, SOP development, audit preparation, and embedding expert personnel.
Design and deployment of global safety databases and data review tools to support AE/SAE processing and regulatory submissions.
Expertise Areas
- Clinical trial management
- Pharmacovigilance and safety monitoring
- Regulatory submission support (IND/NDA/BLA)
- Medical monitoring and clinical oversight
Key Technologies
- Global safety databases
- Electronic data capture (eCRF/EDC) review
- MedDRA and WHO Drug coding
- Signal detection and data mining
News & Updates
An article providing tips on effective communication with clients.
An article discussing the latest trends in UX design for 2020.
An article on cause marketing and its benefits.
An article debunking common myths about graphic design.
Comprehensive evaluation of IND review including proposed clinical trials, safety assessment, and risk management during clinical trials.
Information about G2's services in global clinical trials, including medical safety services and support for CROs.
An article providing tips on effective communication with clients.
An article discussing the latest trends in UX design for 2020.
An article on cause marketing and its benefits.
An article debunking common myths about graphic design.
Comprehensive evaluation of IND review including proposed clinical trials, safety assessment, and risk management during clinical trials.
Information about G2's services in global clinical trials, including medical safety services and support for CROs.