Partners and Clients
Global Healthcare Consulting is an International Consulting, Research, Policy and Communications Organization.
We have a track record of research projects and partnerships that are highly innovative, large, globally distributed (built through the collaboration of several international institutions) and cost-effective. We are a team of vaccine experts, clinical researchers, pharmacovigilance experts, epidemiologists, social scientists and communications experts.
Our partners and clients include Scientific Research Organisations, Academia, Government Institutions, Industry and International Organisations.
Examples of Projects
- Development of the clinical and regulatory strategy for a new vaccine in clinical development
- Development of the clinical and regulatory strategies and clinical development plans for new drugs in clinical development – For an International R&D organization developing new drugs for infectious diseases
- International regulatory landscape analysis for Maternal Immunization clinical research – GHC conducted a detailed landscape analysis of the regulatory guidelines for immunization in pregnancy for the WHO Initiative for Vaccine Research’s Consultation. We helped organize a regulatory session with key regulators from the FDA, EMA, Asia and Africa at an international consensus conference at the National Institute of Health, USA.
- Defining the international and country-specific regulatory and safety guidance for vaccines for epidemics clinical research – GHC helped to define the international (FDA, EMA) and country-specific regulatory and safety guidance for Phase I-III clinical research for new vaccines for epidemics.
- Development of a risk-management plan for a new vaccine in clinical development
- Protocol development and feasibility assessment of maternal and neonatal outcomes following maternal immunization
- Benefit-risk assessment of COVID-19 vaccines- GHC led the development of standardized templates with key considerations for the benefit-risk assessment of vaccines. These are being utilized by vaccine developers.
- Determining AESI (adverse events of special interest) for a vaccine in clinical development
- Maternal and neonatal outcomes and guidance development for pharmacovigilance of vaccines- GHC helped in developing 26 novel maternal and neonatal case definitions for adverse events detection and evaluation, and co-authored guidelines for vaccines in pregnant women clinical research. The definitions and guidance are being utilized in clinical research, epidemiological studies, and pharmacovigilance for vaccines and maternal immunization globally.
- Pharmacovigilance for Maternal Immunization- GHC helped set up the Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) network, a critical program for maternal immunization safety, and was part of the Coordination and Executive Committees. The GAIA project was a large consortium of thirteen global partners with partners in over 90 countries. The standards, guidance, and tools developed are being utilized for pharmacovigilance for vaccines globally.
- Maternal Immunization Pharmacovigilance Program Strengthening for LMIC- GHC was part of the Core Planning Group which worked to build a strategic framework for immunization in pregnant women pharmacovigilance systems in LMIC.
INCREASING IMMUNIZATION COVERAGE AND ACCEPTANCE AND NEW VACCINE INTRODUCTION
- COVID-19 Vaccine safety answers (including on adverse events) for healthcare providers- GHC is co-leading an international working group to provide answers to COVID-19 Vaccine safety questions (including on adverse events) to facilitate vaccines acceptance and uptake. The work is being utilized by Public Health Authorities and WHO’s Vaccine Safety Net partners in 112 countries.
- Increasing immunization coverage and acceptance in LMICs- We led research to understand the barriers and drivers to immunization acceptance in parents in Africa. Based on research, we designed a novel tool to increase the uptake and acceptance of vaccines among parents and help in healthcare worker training. The research was conducted in close partnership with the National Government and EPI team. The tool were found to be very effective.
VACCINES FOR EPIDEMICS PREPAREDNESS AND HEALTH SYSTEMS STRENGTHENING
- Pandemic Preparedness and Response – For the World Health Organization (WHO), we conducted an in-depth review, monitoring and evaluation, and reporting of the impact and achievements of the PandemicInfluenza Preparedness (PIP) Implementation in South East Asia in the priority countries and in the Regional Office.
- Research Ethics for Vaccines in Epidemics- GHC was part of the Expert Working Group of a project, led by Johns Hopkins to develop Ethical Guidance for the preparedness, clinical research, and implementation for vaccines for epidemics administered to Pregnant Women. This led to a change in the policy for the inclusion of pregnant women for receipt of Ebola vaccines in the Democratic Republic of Congo.