G2 BioPharma Services Inc.

Medical Safety Solutions to

FIH Clinical Trials

What Does G2 Offer?

1.Experienced IND application expert team (RA, Medical, Safety, PK/PD, Toxicology, Nonclinical, CMC)
2.Study design communication strategy with HAs (e.g., FDA, PMDA, NMPA)
3.Consultation on critical study documents ( protocol, IB, ICF, MMP, SMP, DSMB Charter, SAP) development
4.24/7 expert services in medical monitoring, safety monitoring, and regulatory reporting (e.g., IND safety report / SUSAR, DSUR)

usability

G2 Services

  • Global standard
  • 24/7 coverage
  • Expert network
  • Compliance-focused
  • Quality-driven
  • Cost effective

flexible

G2 Clinical Trials Services

Global or Local Clinical Trials Medical Safety Services

1.Medical monitoring

2.Safety monitoring

3.24/7 SAE/SUSAR processing and medical review

4.Global safety database/tools for safety data processing and submission

5.Periodic aggregate safety data reporting (DSUR)

6.New safety signal/AESI detection and risk mitigation strategies

7.SOPs, quality control, trainings, and compliance tracking

8.Site and company external/internal audit and inspection

professional

US FDA IND/NDA Submission and Safety Data Consulting Services

US FDA IND/NDA Submission and Safety Data Consulting Services

1.IND application submission safety monitoring strategy and regulatory communication

2.NDA integrated summary of safety development and submission

3.Global experts/KOLs networking and IRB/EC interaction

4.Trial safety review committee, DSMB/DMC, and interim analysis

important opinion

G2 Expertise
Clinical Trials Medical Monitoring

*Protocol design, study objectives/endpoints, research subjects/patient population, AEoSIs

*Ongoing medical safety monitoring planning activities and therapeutic area/indication training of CRAs.

*Communication with DSMB or DMC

*Medical review of data (e.g., eCRF, questionnaires for safety and efficacy data and parameters AE / SAE Management)

*Review of AEs and SAEs for any specific medical safety trend analyses

*Review SAE narratives for accuracy, consistency, causality and follow-up on queries, if needed

*Consult with safety team on SAEs and clarify information

*Review of safety data listings (predefined or ad hoc EDC data outputs)

*Provide investigator site training on study-related medical issues during Kick-off meeting, Investigator Meeting and Site Initiation Meeting

*Serve as medical oversight contact for investigator site staff and CRAs for patient randomization and eligibility

*Manage medical questions on the protocol (e.g., clarification of inclusion/exclusion criteria, permitted/non-permitted concomitant medications, any medical issues in agreement with the protocol requirements) and protocol exemptions/deviations/violations

*Ongoing medical support and maintain in-depth knowledge of protocol and product at the level of the Investigator’s Brochure and product safety profile

*If required, visit site to review source documents to ensure compliance to medical parameters described in the protocol and identify training needs

*Review of data management coding for consistency (adverse events, prior and concomitant medications, and previous medical history)

*Safety Management Plan (SMP) preparation

*Medical Safety Helpdesk Service (24/7 Availability)

*Collection of SAEs/other reportable events from sites via dedicated fax lines or by e-mail

*SAE case processing in safety database (incl. case receipt/triage, data entry/coding, validation/QC, medical review. Coordinate sponsor medical safety team review if needed.

*Issue/follow up/ review/close safety and medical queries (per Medical Monitor/Safety Physician).

*Expedited reporting (e.g., SUSARs) to regulatory health authorities through specific applicable reporting tools

*Reporting SUSARs/SAEs to IRBs/ECs and investigators per applicable regulation or sponsor requirements

*Maintenance of the safety documentation in a secure safety file per project or sponsor requirements

*Reconciliation of SAEs between safety database and clinical database

*Cooperation in the activities of safety data monitoring committee (DMC or DSMB)

*Develop periodic aggregate safety data update reports (e.g., DSUR)

*Safety data analyses related tasks: Safety signal detection and management, safety management team meeting review, safety reference information/IB update, CSR safety data summary and overall assessment

Safety Signal Detection and Risk Management

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G2 Expertise Global Expert Consultation

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*Integration of pooled safety data for summary and HA submission (IND, NDA, SCS, ISS, CSR)

*Medical safety review of ICSRs (SAEs, SUSARs, US IND safety report & AOSIs, targeted FU)

*Development of aggregate periodic safety data update reports (DSUR, PBRER, PSUR)

*Maintenance of product risk management profile and safety reference documents (RMP, REMS, R/B Assessment, IB/RSI, DCSI, CCSI/CCDS, local labels, e.g., USPI, SmPC, JPI )

*Detection and management of safety signals (data retrieval & management, signal evaluation strategy, data mining & interpretation)

*Medical safety review of published literature (screening, search strategy, findings summary)

*Global safety management team and company safety governance establishment

*Clinical trials safety and post-marketing PV on the job trainings

*Global safety quality system set-up and audits and inspection preparation

*Medical assessment of safety-related product complaint/quality issues/recall/withdrawal

*Development of global safety database, data review tools and applications