about us

ABOUT G2-BPS

G2 BioPharma Services Inc.

We are a global full service pharmacovigilance provider that serves biopharmaceutical companies and Clinical Research Organizations through its innovative platform for Clinical Safety and Pharmacovigilance. Our global reach and tailored solutions give our clients an advantage with precise around the clock services.

Vision

Our vision is to become an innovative premier provider of full services and solutions of Clinical Safety and Pharmacovigilance to the Biopharmaceutical and CROs industries worldwide.

Mission

Our mission is to provide our clients innovative comprehensive safety solutions to ensure patient’s safety and to comply with regulatory requirements.

Team Leader

Daniel Yang, M.D., Ph.D.

Doctor Yang has over 30 years of experience in the medical world and has used his educational background to build a wide range of experience both domestically and internationally. As an expert in medical safety and post marketing pharmacovigilance, his past professional experience includes working for large pharmaceutical company (e.g., nearly 10 years with Bristol-Myers Squibb where he served as a medical director and global safety management team leaders in multiple therapeutic areas such as Oncology, Anti-infectives, and Cardiovascular disorders) as well as in large and small CROs where he first fostered hands-on experience in the field. For the past 8 years, Dr. Yang and his medical safety expert team has provided reliable high quality global standard services around the clock, for small, medium and large size pharmaceutical companies in the US and Asian Pacific regions. By partnering with a safety IT Company that helps to provide global standard safety database and safety signal and data management tools, Dr. Yang and his company G2 BioPharma Services Inc. are ready to provide best-in-class pharmacovigilance and risk management solutions for their clients.

Expertise Highlights

Rich pharmaceutical industry experience with extensive expertise and proven excellence in pre- or post-approval global clinical safety and pharmacovigilance

Management of multidisciplinary matrix global medical safety surveillance teams
Safety signal detection and data mining (e.g., MGPS)
Product risk management plans (e.g., EU RMP, US REMS),
Global company or development core safety information or local labels (including CCDS, IB, USPI, SmPC)
Medical safety assessment of individual case safety reports (ICSRs) (e.g., SAEs, ESRs, or SUSARs) or periodic aggregate safety updates (e.g., PSUR, PADER, ASR, DSUR, PBRER)
Integrated safety summary documents (e.g., SCS, ISS) or other safety related clinical trial documents (e.g., protocols, CSRs, IB, CRF, ICF)
Medical safety monitoring for Phase 1-4 clinical trials with good knowledge of GCP and clinical project management,
Support of global regulatory filings (e.g., NDA, MAA submissions),
Knowledge and experience in pharmacoepidemiology and biostatistics,
Assessment of product quality issues and product recall/withdraw,
Training new safety physicians or scientists, and
In-depth knowledge and experience in PV system, clinical database, clinical safety and PV outsourcing or off-shore activities.

The G2 Safety Team

Our safety team is based in the USA, and is prepared to meet all your needs around the clock and around the world. By working together with your existing safety teams, our team of safety experts can assist in any safety capacity.

Team Composition

Our professional and passionate team includes, but is not limited to, the following:

safety physicians
medical safety reviewers
safety scientists
medical scientific writers
safety system (database) experts
clinical database DM managers
SAS programmers
Pharmacoepidemiologists
ICSR data entry and QC managers (specializing in Argus, ARISg)
safety managers for Quality, Standard and Training

Team Expertise

Medical review of individual case reports (e.g., AE, SAE, ESR, SUSAR); AE Case Entry (ICH E2B Standard), MedDRA Coding, WHO Drug Coding, narratives writing, query tracking, targeted follow-up.
Aggregate Safety Reports： 1 Periodic safety update reports (e.g., PSUR, PADER, PBRER, ASR, DSUR, IND Annual Report, Summary Bridging Report, Addendum) 2 Ad Hoc Safety Reports (e.g., Clinical overview/summary for labeling update, Safety expert report for assessment of safety queries) 3 Other reports (e.g., Medical impact analysis (MIA) reports, Safety summary, Customized line listings and summary tabulations for aggregate data)
Safety signal detection and data mining (e.g., MGPS), Labs, ECG, Holter Data Summary, development of targeted questionnaires for AEoSIs, integrated review of clinical trials data across protocols or programs, and Pharmacoepidemiology r
Risk management planning and development (e.g., EU RMP, US REMS); risk data summary, risk minimization activities, ongoing evidence-based risk/benefit assessment, RMP related PV activities (PSUR, PBRER, CCDS/product labeling update, safety studies), overall assessment of benefit/risk balance.
Development of company core safety documents (including DCSI, IB, CCDS) and local labels.
Review and development of safety sections in the clinical study reports; preparation of integrated clinical safety summary (e.g., SCS, ISS).
Development of safety related clinical trial documents (e.g., protocols, CSR, IB, CRF, ICF, SMP, MMP, SAE form).
Medical safety monitoring in Phase 1-4 clinical trials; ongoing safety data monitoring and assessment of potential new and unexpected safety signals.
Strategic support and consultation for global new drug filings (e.g., NDA, MAA submissions).
Post-marketing PV activities including review of spontaneous case report and published literature, development of labeling updates, database review, PV system updates, preparation of PV audit and inspection, assessment and management of product quality issues and product recalls/withdrawal.
PV medical safety assessment trainings, PV SOPs/ WIs/ templates development
Other safety-related activities: medical safety regulatory consulting services, safety data exchange agreement (SDEA) development, strategic planning in the development and growth of your safety departments, establish and manage medical safety related off-shore and outsourcing models and activities.