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 a functioning internal PV 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,  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.

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 roster 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