Clinical & Regulatory

Bringing it all together

phase-III-efficacy-Kolkata
Following technology transfer, we work with our manufacturing partners to demonstrate safety and protective efficacy in humans through clinical trials. We also provide support to manufacturers in preparations for vaccine registration and WHO prequalification.

Clinical trials are a critical step in developing a vaccine. They assess the safety of a new vaccine, its ability to induce an immune response, and its efficacy in human subjects. Trials may also assess best strategies on integrating the vaccine in national immunization programs. We coordinate clinical trials with various partners in countries around the world.

What We Do

Clinical development

  • Design and implement clinical development strategy (phase I – IV).
  • Prepare and conduct clinical studies in accordance with GCP and other requirements.
  • Provide training and technical support to partners in assessing vaccine safety and efficacy in populations in developing countries.

Data management and biostatistics

  • Provide technical support in clinical trial design.
  • Conduct data collection, management and analysis

Regulatory

Provide training and technical support to developing country manufacturers and national regulatory authorities (NRAs) in aspects related to vaccine regulatory review and approval such as vaccine safety.
IVI is a participating member of WHO’s Global Vaccine Safety Initiative (GVSI) that aims to ensure that all countries have capacity to ensure vaccine safety, with a focus on building and supporting a systemic approach to vaccine pharmacovigilance in low- and middle-income countries.