Global Healthcare Consulting (GHC) offers a wide range of consulting services for clinical research (phase I-IV) for vaccines and drugs, pharmacovigilance, epidemiology, policy, communication, introduction of new vaccines, increasing immunization coverage and acceptance and immunization programs strengthening.
GHC provides expert services in the following areas:
Clinical Research
GHC supports the following activities for global phase I-IV clinical research for vaccines and drugs in the USA, Europe, Africa and Asia in adult, adolescent, maternal and pediatric populations
Development and management of
- Clinical project strategy
- Clinical development plans
- Clinical and Regulatory strategies
- Development of the
- Target product profiles
- Protocols
- Investigators Brochures
- Informed consent
- Care and treatment guidelines for research participants
- Clinical sections for regulatory applications for FDA, EMA, African and Asian national regulatory authorities
- Regulatory landscape analysis
Pharmacovigilance
The following activities are supported by Global Healthcare Consulting for vaccine and drug safety assessment during Phase I-IV clinical research and post introduction
- Risk management plans and risk evaluation and mitigation strategies
- Benefit-risk assessment
- Periodic Study Reports
- Adverse Event management
- Aggregate case reviews
- Signal detection and evaluation
- Training
- Data and safety monitoring board (DSMB) and independent data monitoring committee (IDMC) support
Healthcare Programs Strengthening
For Immunization and Maternal and Child Health programs strengthening, Global Healthcare Consulting supports the development of
- Policy
- Strategy
- Communications
- Evaluation
- Capacity building
- Supply chains strengthening
- Ethical strategies for vaccine implementation (including for vaccines for pregnant women and epidemics)
- Increasing immunization coverage and acceptance in LMICs
- New vaccines introduction
Epidemiology
- Systematic literature reviews, done to tight timelines
- Observational studies including protocol writing, investigator identification, study documents preparation, data collection, analysis and report writing
- Publication writing
Advocacy
GHC partners with clients to create advocacy strategies that influence national and global policy, identify and engage with key stakeholders, and position the organization and issues that advance our clients’ specific objectives. We help our clients engage with potential partners, new audiences, stakeholders and donors.
Communications
GHC develops communication strategies for organizations, programs, new vaccines and drugs and new initiatives. We work on strategic planning, key messaging, material development, dissemination, and targeted media outreach.
Writing
Writing of reports, manuscripts, conference abstracts and grants
Training
We design and implement training in the following areas for investigators, researchers, Institutional Review Boards, Ethics Committee members, DSMBs, National Program Managers and healthcare providers. The training utilizes adult training approaches, is participatory and ensure competency. We provide training in
- Clinical research
- Pharmacovigilance
- Novel vaccines and drugs development
- Platform technologies
Project Management
We specialize in managing complex international research programs. We manage projects with a great variety of stakeholders (academia, industry, public sector, public-private partnerships, NGOs, and community-based organisations). We help drive the programs towards achieving milestones and successful completion within tight budget and timelines.