G2 BioPharma Services Inc.

Global Partnership in

Contract Clinical Trial Services

our services

Partner with CRO in Global Clinical Trial Projects

Direct benefits to CRO

Higher chance for Bid success + broader service scope = better industry reputation and increasing company business income 

Added benefits

G2-BPS is SME in following critical processes:

(1)Contribute in CRO’s medical, clinical safety/PV teams building

(2)Help CRO to better prepare client’s business audit inspection

Our packages

Partner with CRO

G2-BPS Performs

the following Medical and Safety Contract Services

  • Medical And Safety Monitoring Expert Consultation (Protocol Design, MMP, SMP, DMC)
  • Medical Review Of SAE, SUSAR Unblinding, AESI/AOSE, Targeted FU
  • Signal detection, safety profile update, clinical safety data integration (NDA/ISS, SCS)
  • Product safety risk aggregate data assessment (DSUR, PBRER, IB, CSR, NDA/RMP)
  • Reference safety information development (IND/DCSI, IB; NDA/CCDS/Labels)
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G2-BPS Supports

CRO in the Following Medical and Safety Contract Services

  • Global standard PV system/database establishment, AE/SAE processing and reporting
  • MedDRA/WHO Drug coding, trainings, Literature review, SAE reconciliation
  • Client’s PV Department/study SOPs/WIs/forms development, training, audit/inspection
  • Medical writing for medical and safety reports (SMP, MMP, DSUR, PBRER, IB update, CSR)
  • CRO-Site safety-related communication
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