Clinical Trials Sponsors

Our experienced and knowledgeable PV expert team offers a wide range and global standard clinical trials safety expert solutions to assist our clients in enhancing their safety procedures, operations.

Why Clinical Trials Safety Consulting services?

Expert Services

1. Clinical Trails

2. IND / NDA preparation and submission

Project services

1. Clinical Trails

G2 Expert 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