CRO

CRO

As pharmacovigilance (PV) outsourcing has matured over time, many pharma and biotech companies choose to outsource and offshore the work to contract research organizations (CROs).
 
Some of these CROs outsource PV activities (e.g., processing AE/SAE/SUSAR, developing aggregate data reports DSUR/PSUR/PBRER) to a niche PV expert service provider, due to the high cost of maintaining an internal PV functional team.  In addition, CROs providing PV services may still need to consult with an experienced safety service provider to fill the gaps in their own safety team (risk management, data mining, safety monitoring, etc.). 
 
G2 is an experienced niche service provider specializing in providing custom solutions to fit various CROs needs in clinical trials safety monitoring and post-marketing surveillance and risk management. G2 offers seasoned global expert consultations to CROs to meet their client’s special safety requests to maintain regulatory compliance.

Expert consulting Services

G2 offers in-depth consultations to contract research organizations (CROs) to SUPPORT their existing team with their clients special safety requests.

  • 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:
  • Periodic safety update reports (e.g., PSUR, PADER, PBRER, ASR, DSUR, IND Annual Report, Summary Bridging Report, Addendum)
  • Ad Hoc Safety Reports (e.g., Clinical overview/summary for labeling update, Safety expert report for assessment of safety queries)
  • 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 review.
  • 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.

Solutions

1 Customized Services

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. 

  • Labs/ECG data summary for safety monitoring and signal detection 
  • medical impact analysis for late SAE reports 
  • published literature review and summary 

2 Comprehensive Services

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.

  • full clinical safety services for clinical trials including SAE processing 
  • medical safety monitoring 
  • signal detection
  • DSUR
  • IB update 
  • CSR safety section

3 Team Integration Services

Our professionals are trained in the latest regulations and processes, which allows them to seamlessly assist your existing safety team to achieve safety goals.

We provide experienced medical safety professionals to work alongside your safety team in order to meet your special safety evaluation needs.

  • G2 medical reviewers working in our clients’ ICSR processing teams, 
  • G2 medical scientific writer working with our clients’ safety physicians on DSURs or PBRERs