Global Healthcare Consulting is an International Consulting, Research, Policy and Communication’s Organization. Over many years of working with international consortia in a variety of funding programs, we have built expert knowledge in preparing and implementing small to large collaborative research projects.
We have a track record of research projects and partnerships that are highly innovative, large, globally distributed (built on the collaboration of several international institutions), internationally oriented, cost-effective and sustainable. We draw together a team of public sector experts, scientists, social scientists, communications experts and researchers.
Our partners and clients include:
- International scientific research organisations
- Major academic institutions
- Multilateral and Bilateral organisations
- Global Philanthropic organisations
- For-profit and Not-for-profit organisations
- Government agencies
First in Human Clinical Research – Regulatory, Pre-clinical and Clinical Development Plans
For an International Research and Development organization that is developing new drugs for Infectious Diseases in the US, Europe, Asia, Africa and South America, Global Healthcare Consulting helped to define the regulatory, pre-clinical and clinical development requirements for a first-in-human clinical trial in India for novel drugs and compare these with the requirements in the US and Europe.
Maternal Immunization Clinical Research- International Regulatory Landscape Analysis
Global Healthcare Consulting conducted a detailed landscape analysis of the regulatory guidelines for Immunization in pregnancy for the WHO Initiative for Vaccine Research’s Consultation in Geneva.
This included the US FDA (Food and Drug Administration), EMA (European Medicines Agency) and ICH (International Conference on Harmonization) guidance and regulatory guidelines review and discussions with the FDA, EMA and National Regulatory Authorities. The results of the landscape analysis were incorporated in a Guidance document (https://www.sciencedirect.com/science/article/pii/S0264410X16306156?via%3Dihub).
We helped organize a regulatory session with key regulators from the FDA, EMA, Asia, Africa and China at the Harmonized Safety Monitoring of Immunization in Pregnancy International Consensus Conference held at the National Institute of Health, USA.
Vaccine for Epidemics Clinical Research- Regulatory Landscape Analysis
Clinical research for vaccines against epidemic diseases is ongoing globally. Global Healthcare Consulting helped to define the international (FDA, EMA) and country-specific regulatory guidance for these trials for an international organization working on the development of novel vaccines for infectious diseases.
Immunization in Pregnancy Safety Studies and Surveillance in Low and Middle-Income Countries- Field Performance of Novel Case Definitions
Global Healthcare Consulting worked with partners in The Gambia and South Africa to evaluate the field performance of novel maternal and neonatal case definitions which are being used for clinical research and studies for vaccines for pregnant women and maternal and child health globally. This was work funded by the UK’s Global Challenges Research Fund (GCRF).
Standardized templates for the benefit-risk assessment of COVID-19 vaccine candidates
GHC led the development of standardized templates with key considerations for the benefit-risk assessment of COVID-19 vaccine candidates has been led by. The templates have been developed for all the platforms being utilized for COVID-19 vaccines (including nucleic acid (RNA and DNA), protein, inactivated viral and live attenuated viral vaccines) and been published (https://doi.org/10.1016/j.vaccine.2020.06.017, https://doi.org/10.1016/j.vaccine.2020.06.044, https://doi.org/10.1016/j.vaccine.2020.07.028)
The templates were endorsed by WHO’s Global Advisory Committee on Vaccine Safety (GACVS) in May 2020. They are being utilized by vaccine developers, including those funded by Coalition for Epidemic Preparedness Innovations (CEPI), to evaluate and communicate the benefit-risk of COVID-19 vaccine candidates.
Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project on safety assessment of vaccines in pregnancy
Global Healthcare Consulting helped set up the GAIA project and was part of the Coordination and Executive Committee. The GAIA project, funded by the Bill and Melinda Gates Foundation, was a large consortium of thirteen global partners.
GAIA aimed to improve clinical outcome data of vaccine safety and effectiveness studies for maternal immunization with a specific focus on Low and Middle-Income Countries (LMIC). GHC’s focus was on harmonization of the standards, guidance and tools developed with particular emphasis on applicability and usefulness in LMIC.
Maternal Immunization Pharmacovigilance Program Strengthening for Low and Medium Income Countries
Global Healthcare Consulting was part of the Core Planning Group which worked to build a strategic framework for immunization in pregnant women pharmacovigilance systems in LMIC. The aim was to identify gaps and define systems required to adapt and implement pharmacovigilance systems specifically designed for monitoring the safety of vaccines for pregnant women, the developing fetus, and infants in LMIC following maternal vaccination for RSV, GBS, and pertussis. This was funded by the Gates Foundation (https://www.gapps.org/PDF/MaternalImmunizationSafetyMonitoringInLMICs.pdf).
Maternal Immunization- Case Definitions and Guidance Development
Global Healthcare Consulting was the Overall Lead for the development of 26 Maternal and Neonatal Case Definitions for Maternal Immunisation (MI) and co-authored guidelines for vaccines in pregnant women clinical trials and studies (https://www.sciencedirect.com/journal/vaccine/vol/35/issue/48/part/PA, https://www.sciencedirect.com/journal/vaccine/vol/34/issue/49). The definitions and guidelines are being utilized in clinical research, observational studies and AEFI surveillance for Vaccines and Maternal and Child Health Research globally.
COMMUNICATION AND IMPROVING VACCINE UPTAKE IN LMIC
We worked to develop a novel audio-visual tool for communication about vaccines, addressing vaccine hesitancy and improving vaccine uptake in LMIC. This was a study funded by the Gates Foundation. The tool was found to be very effective.
VACCINES FOR EPIDEMICS PREPAREDNESS AND HEALTH SYSTEMS STRENGTHENING
For the World Health Organization (WHO), Global Healthcare Consulting conducted an in-depth Review, Monitoring and Evaluation (M&E), Assessment and Reporting of the achievements and impact of the Pandemic Preparedness (PIP) Implementation in South East Asia. The activities done in the priority countries and in the Regional Office were reviewed for Burden of Disease, Laboratory and Surveillance, Regulatory Capacity Building, Planning for Deployment, and Risk Communications. The information was used by WHO for risk-assessment, communication, and advocacy.
Research Ethics for Vaccines in Epidemics
Global Healthcare Consulting 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.