Global Healthcare Consulting (GHC)
Dr Sonali Kochhar has twenty years of experience in a leadership position for Global Phase I-IV International Clinical Research, Epidemiological and Safety Studies for Vaccines and Drugs including Vaccines for Pregnant Women, Infectious Diseases, Maternal and Child programs and Health systems strengthening. These have been conducted in the USA, Europe, Asia, Africa and India in adult and paediatric populations. She also works on Policy Development and Strategic Planning with international Government Partners, Public Health Authorities, Regulatory and Ethical Committees and Local Communities.
She has co-authored guidelines for collection, analysis and presentation of safety data for vaccines in pregnant women clinical trials and studies. She has co-authored multiple internationally accepted Research Standards, Case definitions, Guidelines and Template Research Protocols for Vaccine Safety Research.
She was on the International Steering Committee of the WHO Consultation on Safety of Immunization in Pregnancy in Mothers and Newborn Children and served as the Session Chair for the WHO Paediatric Deliberative Session on Neonatal Events in Maternal Immunization. She serves on various International Steering Committees, including the Medical Research Council funded Immunizing Pregnant Women and Infants (IMPRINT) network, an Expert Working Group member of Wellcome Trust funded PREVENT (Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies) Project and is on the Medical Advisory Panel for Group B Strep Support. She has been a member of special interest groups on Maternal Immunization at NIH and was on the Steering Committee of the Maternal Immunization Pharmacovigilance programs for LMICs. She is a Brighton Collaboration Science Board member and has been involved with developing guidelines and case definitions with the Brighton Collaboration for 10 years.
Contribution to the consortium
Dr Kochhar will lead Outcome 1 (Standard development). GHC will stay in charge of harmonizing case definition and guidelines development. Having harmonized over GAIA 21 case definitions, GHC brings its experience to translating the case definitions to CRFs. GHC will also participate in the development of the ORAT Tool, the SMQs and the case definition mapper. GHC main role is the integration and harmonization with the case definitions. GHC has actively represented GAIA at various occasions and will continue to do so. In the impact assessment work stream, GHC also has an outreach and crosslinking role, while actively contributing to protocol development and study implementation. GHC will remain member of the Coordination team and thus support project coordination and management.