Focus On Sites
By working with a range of capable sites, we can reach at-risk populations, bring interventions to those who need it most and address public health issues around the globe.
WE HAVE RELATIONSHIPS WITH SITES WORLDWIDE
Our database of research-ready sites includes approximately 2,700 sites worldwide, with experience spanning all clinical trial phases, infectious and non-communicable diseases as well as pediatric and adult populations.

Are you a site interested in being considered for future studies with FHI Clinical?
Complete the form, and we will contact you to arrange a formal introduction with the FHI Clinical team for further evaluation of your site.
WE PARTNER WITH SITES

- The FHI Clinical website and social media
- Meeting FHI Clinical staff in person via a conference or other event
- Networking and referrals to FHI Clinical
- A survey is sent to the institution, to collect details such as (but not limited to) clinical research experience, disease experience and prevalence, phase and population experience, lab capabilities and contact information.
- FHI Clinical uses the survey information to aid with designing feasibility strategies and site lists for future sponsored studies
- Once an institutional profile has been created, FHI Clinical maintains regular contact with these institutions. This ensures that both parties have current and accurate information about each other’s relevant capacity and bandwidth.
- Sites in the database may also provide insight on protocol design and recruitment strategies to ensure both FHI Clinical and the sponsor have accurate real-world information.
SITE AND INVESTIGATOR SPOTLIGHT

About Dr. Makadzange
Tariro Makadzange founded CRMG and Mutala Research in late 2021, to help address the need for expertise in pandemic responsiveness and clinical trials in Africa, following more than 15 years of experience in clinical, academic and pharma roles. Her research has focused primarily on HIV immunology and implementation science as well as related opportunistic infections such as cryptococcal meningitis, in both perinatally HIV-infected children/adolescents and HIV-infected adults. She has trained and mentored clinicians and researchers in HIV and co-established the Parirenyatwa Hospital Family Care Centre (PHFCC) at the University of Zimbabwe College of Health Sciences (UZCHS), which is now one of the largest HIV treatment programs in Zimbabwe. In the pharmaceutical industry, she led a therapeutic vaccine research program at Gilead Sciences.
She earned an MD at Harvard Medical School and a PhD (DPhil) in Immunology at the University of Oxford University. She trained in Internal Medicine at the University of Washington and completed a fellowship in Infectious Diseases at Massachusetts General Hospital and Brigham and Women’s Hospital, where she later joined the faculty and formed a research partnership that resulted in the establishment of the Infectious Diseases Research Laboratory in Harare. She has also held academic positions at Harvard Medical School, Stanford University and the University of Zimbabwe.
- Attitudes to vaccine mandates among late adopters of COVID-19 vaccines in Zimbabwe. Vaccines. July 2022
- Investigating attitudes, motivations and key influencers for vaccine uptake among late adopters of COVID-19 vaccination in Africa. Preprint. April 2022
- Evaluation of HIV-1 reservoir size and broadly neutralizing antibody susceptibility in acute antiretroviral therapy-treated individuals. AIDS. February 2022
- Brief report: efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide in females living with HIV: an integrated analysis of 5 trials. Journal of Acquired Immune Deficiency Syndrome. December 2021
- Survival following screening and preemptive antifungal therapy for subclinical cryptococcal disease in advanced HIV infection. AIDS. October 2021
- The transient effect of a peer support intervention to improve adherence among adolescents and young adults failing antiretroviral therapy in Harare, Zimbabwe: a randomized control trial. AIDS Research and Therapy. June 2021
- Diagnostic accuracy of pan-degenerate amplification and adaptation assay for HIV-1 drug resistance mutation analysis in low- and middle-income countries. Journal of Clinical Microbiology. August 2020
- Plasma concentration of neurofilament light chain protein decreases after switching from tenofovir disoproxil fumarate to tenofovir alafenamide fumarate. PLoS One. December 2019
- Switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF) in virologically suppressed HIV-1 infected women: a randomized, open-label, multicenter, active-controlled, phase 3, noninferiority trial. Journal of Acquired Immune Deficiency Syndrome. November 2019
- Trends in pretreatment HIV-1 drug resistance in antiretroviral therapy-naive adults in South Africa, 2000–2016: a pooled sequence analysis. eClinicalMedicine. March 2019
- Independent and combined effects of improved water, sanitation, and hygiene, and improved complementary feeding, on child stunting and anaemia in rural Zimbabwe: a cluster-randomised trial. The Lancet: Global Health. January 2019
- Antibody responses in HIV-infected patients with advanced immunosuppression and asymptomatic cryptococcal antigenemia. Open Forum Infectious Diseases. December 2018
- Superior efficacy and improved renal and bone safety after switching from a tenofovir disoproxil fumarate- to a tenofovir alafenamide-based regimen through 96 weeks of treatment. AIDS Research and Human Retroviruses. April 2018
- A simple phosphate-buffered-saline-based extraction method improves specificity of HIV viral load monitoring using dried blood spots. Journal of Clinical Microbiology. June 2017
- Clinical, virologic, immunologic outcomes and emerging HIV drug resistance patterns in children and adolescents in public ART care in Zimbabwe. PLoS One. December 2015
- The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial: rationale, design, and methods. Clinical Infectious Diseases. December 2015
- Plasma concentrations of hepcidin in anemic Zimbabwean infants. PLoS One. August 2015
- ‘I was thinking too much’: experiences of HIV-positive adults with common mental disorders and poor adherence to antiretroviral therapy in Zimbabwe. Tropical Medicine & International Health. March 2015
- AMBITION-cm: intermittent high dose AmBisome on a high dose fluconazole backbone for cryptococcal meningitis induction therapy in sub-Saharan Africa: study protocol for a randomized controlled trial. Trials. June 2015
- Setting the research agenda in a resource-limited setting–viewpoint. Journal of Acquired Immune Deficiency Syndrome. January 2014
About CRMG

Overview and mission
- Founded in 2021
- Clinical research organization (CRO) focused on diversifying research by including Africans in medical clinical trials.
- Mission: To work alongside innovators to support clinical development of therapeutics by providing world-class clinical research services in Africa
- CRMG is staffed by African physicians and scientists committed to developing world-class research in Africa that is Africa-focused, Africa-led and globally partnered.
- Clinical trial site
- Clinical operations
- Project management
- Clinical monitoring
- Medical monitoring
- Laboratory and diagnostic services
- Quality assurance
- Clinical data management
- Medical, scientific and regulatory writing
- HIV
- HIV-related opportunistic infections
- COVID-19
CRMG organizations

- Vaccine hesitancy
- Vaccine effectiveness
- Adolescent HIV treatment cascade
- Management of individuals with advanced HIV disease and opportunistic infections
- Burden of disease in Africa

- Basic immunology and virology research in infectious diseases pertinent to the developing world
- Located at the University of Zimbabwe College of Health Science

The research site: CRMG
CRMG, Mutala Research and IDRL are located in Harare, the capital of Zimbabwe, with a population of more than 1.6 million people in the city and 2.8 million people in the metropolitan area.
Staff
- Clinicians who are specialists in clinical trials, vaccinology, internal medicine, nephrology, infectious diseases and pediatrics
- Researchers
- Laboratory scientists with +15 years of clinical trials experience
Therapeutic areas of focus
- Cardiovascular disease
- Endocrinology
- Oncology
- Hematology
- Nephrology
- Infectious diseases
- Women’s health
- Pediatric and adolescent health
- Vaccines
Recent or ongoing research
- COVID-19 vaccine hesitancy study
- COVID-19 vaccine effectiveness study
- Phase I COVID-19 vaccine research study
Capabilities
- HIV viral load monitoring
- SARS CoV-2 monitoring
- PCR
- 14-color flow cytometry (BD Fortessa)
- ELISpot assays
- PBMC isolation
- Cell processing and storage
- Biochemical analysis including LFTs
- Endocrinology studies
- Lipid profiles
- Inflammatory markers
- HIV sequencing
- HIV drug resistance testing
- SARS-CoV-2 sequencing
- General sequencing
- Complete blood count
- Coagulation studies
Future research
The disease profile of Zimbabwe

5th
highest HIV prevalence rate in the world
13%
prevalence of HIV among adults
30%
8%
mother-to-child transmission rate
#1
cause of non-neonatal child deaths
26%
32
incidence of malaria (per 1,000 population at risk)
50%
of the population at risk of malaria infection
12%
of malaria cases detected among children
Each quarter, we shine the light on one of the investigators in our database as well as his or her site(s) and the research priorities in the country.
The current Site and Investigator Spotlight introduces Nsengi Ntamabyaliro, MD, MSc, from the Unit of Clinical Pharmacology and Pharmacovigilance (UPC-PV), University of Kinshasa, in Kinshasa, Democratic Republic of the Congo (DRC). FHI Clinical has worked with Dr. Ntamabyaliro on Phase 3 and 4 trials since 2007, at which time there was a focus on research capacity development in the DRC. Based on this history, FHI Clinical and Dr. Ntamabyaliro are currently collaborating with the UPC-PV on vaccine clinical trials and are working to identify opportunities to keep the research team active at the UPC-PV and the Kinshasa School of Public Health to sustain their research capacity.

About Dr. Ntamabyaliro
Nsengi Ntamabyaliro is a medical doctor who specialized in pharmacoepidemiology and pharmacovigilance. Since 2007 and following his clinical practice in surgery and internal medicine, Dr. Ntamabyaliro has been involved in different roles in many clinical trials: supervisor, site coordinator, co-investigator and principal investigator. His research has focused primarily on malaria but has also included trypanosomiasis, monkeypox and Ebola. Dr. Ntamabyaliro worked as a member of the pharmacovigilance team during the study of EBANGA™, one of the two drugs currently approved by the FDA for the management of Ebola virus disease.
- Determinants of Patients’ Adherence to Malaria Treatment in the Democratic Republic of the Congo. Tropical Medicine and Infectious Disease. July 2022
- Effectiveness of pyronaridine-artesunate against Plasmodium malariae, Plasmodium ovale spp, and mixed-Plasmodium infections: a post-hoc analysis of the CANTAM-Pyramax trial. The Lancet: Microbe. May 2022
- Therapeutic efficacy of artemisinin-based combination therapies in Democratic Republic of the Congo and investigation of molecular markers of antimalarial resistance. The American Journal of Tropical Medicine and Hygiene. September 2021
- Knowledge of antimalarials and health seeking behaviour of households in case of suspected malaria in Democratic Republic of the Congo. Tropical Medicine and Infectious Disease. August 2021
- Pyronaridine-artesunate real-world safety, tolerability, and effectiveness in malaria patients in 5 African countries: A single-arm, open-label, cohort event monitoring study. PLoS Medicine. June 2021
- Development of a pharmacovigilance system in a resource-limited country: the experience of the Democratic Republic of Congo. Therapeutic Advances in Drug Safety. July 2019
- The European Medicines Agency’s scientific opinion on oral fexinidazole for human African trypanosomiasis. PLoS Neglected Tropical Diseases. June 2019
- Drug use in the management of uncomplicated malaria in public health facilities in the Democratic Republic of the Congo. Malaria Journal. May 2018
About UPC-PV
- Unit of Clinical Pharmacology and Pharmacovigilance (UPC-PV), University of Kinshasa

UPC-PV was created in 2008 with the missions of education, research and service to the nation in the field of clinical pharmacology, rational use of medicines and pharmacovigilance.
UPC-PV was accredited as a National Pharmacovigilance Centre of the DRC in 2009 with the responsibility of ensuring the safety of medicine use and monitoring of adverse drug reactions (ADRs) in the country.
Research interests include:
- Malaria
- Tuberculosis
- HIV
- Sleeping sickness
- Monkeypox
- Ebola virus disease
- COVID-19
UPC-PV networks include:


The research site: Mount Amba Hospital Center
Staff
- Professors
- Medical doctors who are specialists in pharmacoepidemiology, pharmacovigilance, epidemiology, clinical trials, vaccinology, internal medicine, neurology and pediatrics
- Pharmacists
- Lab techs and nurses with 10+ years of clinical trials experience
Primary diseases treated
- Malaria: #1 cause of morbidity in the country and in the area
- Respiratory tract infections
- Diarrhea
- Non-communicable diseases (e.g., cardiovascular diseases)
Recent research
- Phase 4 malaria study: >2500 patients/episodes enrolled from December 2017 to March 2019
- Ongoing research on a COVID-19 vaccine: over 1500 participants enrolled
- Preparation of a clinical trial on a monkeypox drug within the PALM Consortium
Facilities and capabilities
- Two consultation rooms and four 4-bed patient rooms
- Waiting space for 20+ patients
- Nurse’s room
- Air-conditioned laboratory with blood sampling, microscopy, hematology, biochemistry equipment
- Refrigerators: -20°C; -40°C; -80°C
- Air-conditioned pharmacy with refrigerators, freezer, drug storage, thermometers
- Regular calibration of all devices
- Air-conditioned archive room with secure cabinets
- Electricity back-up equipped with automatic on/off

A new site under construction includes:
- 4 consultation rooms
- 4 large bed rooms for patients/participants
- 1 nurse’s room
- 1 large clinical laboratory
- 1 pharmacy
- 6 offices
- 1 meeting room
The disease profile of the DRC

Malaria
The DRC is the second most affected country in the world: 11% of cases and 13% of deaths worldwide.
The DRC has malaria transmission rates of 97%.
Malaria accounts for 52.2% of admissions in the Mont Amba Health District.
Diarrheal diseases
Diarrheal diseases are the 6th ranking cause of death in the DRC.
There has been no significant progress in the reduction of diarrheal diseases for the past 10 years.
Diarrheal diseases account for 3.2% of admissions in the Mont Amba Health District.
Sickle cell disease
25% of the population in DRC have the heterozygote sickle cell trait (carriers).
10-20% of births have the heterozygote sickle cell trait.
2% of births have homozygote sickle cell (sickle cell anemia).

Future research:
- Interventional and non-interventional studies
- Continuing research for malaria, monkeypox and trypanosomiasis
- Bacterial infections
- Diarrheal diseases
- Non-communicable diseases (e.g., diabetes, hypertension)