Projects

Partners and Clients 

Global Healthcare Consulting is an International Consulting, Research, Policy and Communications Organization.  We are a team of vaccine experts, clinical researchers, pharmacovigilance experts, epidemiologists, social scientists and communications experts.

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.

Our partners and clients include Scientific Research Organisations, Academia, Government Institutions, Industry and International Organisations.

Examples of recent projects

CLINICAL RESEARCH FOR VACCINES AND DRUGS

  • Development of the clinical and regulatory strategy for a new vaccine in clinical development– For an International R&D organization developing vaccines for infectious diseases.
  • Development of a standardized module for vaccine benefit-risk assessment– GHC led the development of a standardized module for vaccine benefit-risk assessment, which is being utilized by vaccine developers, funders and LMIC National Regulatory Authorities.
  • Development of the clinical and regulatory strategies and clinical development plans for new drugs in clinical development – For an International R&D organization developing 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 and 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 diseases with epidemic potential 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 diseases with epidemic potential.

PHARMACOVIGILANCE

  • Characterize the clinical risk factors and biomarkers associated with rare AEFIs and determine the best way to immunize individuals with risk factors for AEFIs – GHC is part of the international network and serves on the Steering Committee
  • Set up a Pregnancy Registry and determine background rates for key maternal and neonatal outcomes in a LMIC in Africa– GHC is helping with this work which is critical for vaccines for maternal immunization clinical research and pharmacovigilance
  • Development of a standardized module for vaccine benefit-risk assessment– GHC co-led the development of a standardized module for vaccine benefit-risk assessment, which is being utilized by vaccine developers, funders and LMIC National Regulatory Authorities.
  • Expedited standardised case definition development for diagnosis of a priority adverse event following immunization (AEFIs) for use in outbreaks- GHC led the development of expedited case definition for diagnosis of an AEFI for use in an outbreak in different resource settings and decreased the standard one-year time for the development of the case definition and publication, to two months, following all standard case definition development processes   
  • Development of a risk-management plan for a new vaccine for infectious diseases in clinical development
  • Development of case definitions for diagnosis of AEFIs for vaccines for infectious diseases
  • Safety assessment of vaccines from different platforms- GHC led the development of standardized templates for the safety assessment of vaccines from different platforms. These were recommended by WHO’s Global Advisory Committee on Vaccine Safety (GACVS), and are being widely utilized by vaccine developers and funders
  • Led the feasibility assessment of implementation of maternal and neonatal outcomes following maternal immunization in LMICs
  • Determining AESI (adverse events of special interest) for vaccines in clinical development in high-income and LMICs
  • Maternal and neonatal outcomes and guidance development for pharmacovigilance of vaccines- GHC helped lead the development of 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. GAIA 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.

NEW VACCINE INTRODUCTION AND INCREASING IMMUNIZATION COVERAGE AND ACCEPTANCE 

  • Capacity building of National Regulatory Authorities (NRAs), National Immunization Technical Advisory Groups (NITAGs), Regional Immunization Technical Advisory Groups (RITAGs), National Causality Assessment Committees and National Institutional Review Boards and Ethics committees – GHC provides capacity building on novel vaccine clinical research, vaccine safety, benefit-risk assessment and maternal immunization.
  • Development of the WHO Evidence Considerations for Vaccine Policy (ECVP) framework– GHC helped lead the development of the WHO ECVP framework, to help in early (pre-phase 3 trial design) alignment between regulators, policy makers and the national, regional and global stakeholders on the clinical trial and observational data or evidence needed for policy and program decisions for new vaccine classes, leading to more rapid new vaccine introduction and increased coverage and acceptance.
  • Increasing immunization coverage and acceptance in LMICs- GHC 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 and the tool were found to be very effective.
  • COVID-19 Vaccine safety answers (including on adverse events) for healthcare providers- GHC co-lead 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.

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 Pandemic Influenza 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.