University Clinical Research Center

M2C5+23G, Unnamed Road, Bamako, Mali

University or Academic Center, Government Research Institution

Serves Western Africa

University Clinical Research Center (UCRC) is a collaborative initiative between the Malian Ministry of Health, Ministry of Higher Education, University of Science, Technique and Technology of Bamako (USTTB) and National Institute of Allergy and Infectious Diseases (NIAID), developed with the goal to facilitate clinical research in Mali. UCRC provides core research capabilities and staff for scientific research, operations, data management, pharmacy and diagnostics, and has an immunocore, molecular and genomic, hematology, and BSL-3 laboratory on site.

Links to previous clinical trials:

https://clinicaltrials.gov/study/NCT05441800

https://clinicaltrials.gov/study/NCT04149106

https://clinicaltrials.gov/study/NCT03017872

Site Capabilities

Clinical Trial Experience

Therapeutic area interests:

  • Cancer
  • Infectious disease

    • Institution has received grant(s) from:

  • National Funder(s)
  • International Funder(s)

    • Sponsors for previous clinical trials include:

  • Academic
  • Government
  • Industry
  • Investigator-initiated

    • Previous clinical trials conducted:

  • Behavioral
  • Diagnostic
  • Drug – biologic
  • Drug – small molecule
  • Epidemiological
  • Observational
  • Surgical
  • Vaccine

    • Study phase capabilities:

  • Phase I
  • Phase II
  • Phase III
  • Phase IV

    • Pediatric research capabilities:

  • Yes

    • Institution Regulatory/Research Ethics Committees

    Frequency of meetings: As needed

    Application turnaround time (IRB/IEC): 3-4 weeks

    Average time from receipt of final protocol to review and approval of study by all relevant committees: 5-6 weeks

    Additional compliance:

  • IRB/IEC in compliance with IC E6(R2) in terms of composition, functions, and operations guidelines
  • Institution and/or local regulation mandates the distribution of study safety reports to IRB/IEC

    • Institution Staffing Resources

    Staff typeStaff available (y/n) and specialty experience
    Research coordinatorYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)
    -Training in Good Clinical Practice (GCP)
    -Training in Good Clinical Laboratory Practice (GCLP)
    Research nurseYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)
    -Training in Good Clinical Practice (GCP)
    -Training in Good Clinical Laboratory Practice (GCLP)
    Research data managerYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)
    -Training in Good Clinical Practice (GCP)
    -Training in Good Clinical Laboratory Practice (GCLP)
    Quality assurance managerYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)
    -Training in Good Clinical Practice (GCP)
    -Training in Good Clinical Laboratory Practice (GCLP)
    BiostatisticiansYes
    -Experience in Clinical Trials
    Training in Human Subjects Protection (HSP)
    -Training in Good Clinical Practice (GCP)
    -Training in Good Clinical Laboratory Practice (GCLP)
    Database programmersYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)
    -Training in Good Clinical Practice (GCP)
    -Training in Good Clinical Laboratory Practice (GCLP)
    EpidemiologistsYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)
    -Training in Good Clinical Practice (GCP)
    -Training in Good Clinical Laboratory Practice (GCLP)
    PathologistsYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)
    -Training in Good Clinical Practice (GCP)
    -Training in Good Clinical Laboratory Practice (GCLP)
    PharmacistsYes
    -Experience in Clinical Trials
    -Training in Human Subjects Protection (HSP)
    -Training in Good Clinical Practice (GCP)
    -Training in Good Clinical Laboratory Practice (GCLP)

    Institution Diagnostic Capabilities

  • Institution has personnel capable of performing diagnostic biopsies

    • Biopsies performed on-site:

  • Core needle biopsy
  • Endoscopic biopsy
  • Fine needle aspirate
  • Liquid biopsy
  • Sentinel lymph node biopsy
  • Skin biopsy
  • Surgical biopsy

    • Laboratory basics:

  • Institution has a laboratory on site
  • Institution sends diagnostic samples to external laboratory
  • Institution’s laboratory has been inspected or audited

    • Laboratory accreditations:

  • College of American Pathologists (CAP)

    • Tests performed on-site:

  • Complete blood count (CBC) with differential
  • Comprehensive metabolic-chemistry panel (CMP)
  • Routine urinalysis
  • Antibody tests
  • Antigen tests
  • Antimicrobial susceptibility and sensitivity
  • Bacterial smear and culture
  • Flow cytometry
  • Fluorescent in situ hybridization (FISH)
  • Fungal culture
  • Genetic testing
  • Histology
  • Immunohistochemistry (IHC)
  • Laboratory-developed tests (LDTs)
  • Microscopy
  • Ova and parasite (O&P) test
  • PCR and/or RT-PCR
  • Other nucleic acid amplification tests (NAATs)
  • Viral culture
  • Viral load

    • Imaging capabilities:

  • Computed tomography (CT)
  • Magnetic resonance imaging (MRI)
  • Positron emission tomography (PET)
  • Nuclear imaging
  • Ultrasound
  • X-ray
  • Pediatric imaging

    • Institution Research Systems, Recordkeeping, and Data Management

  • Institution adheres to informed consent processes compliant with ICH E6(R2)
  • Institution follows ICH E6(R2) for collection and storage of source documentation for paper and/or electronic records
  • Institution stores patient records/source documents (paper/electronic) in a secured, limited access location during and after the trial
  • For source documents collected via electronic data capture, institution has a validated system and site procedures that follow ICH E6(R2) 5.5 guidelines
  • Institution has process in place for proper storage, archiving, and retrieval of essential study document per ICH 8.1
  • Institution study monitors have full access to source documents or certified copies of source documents (if electronic) if direct access can’t be obtained
  • Institution has a finance administration team
  • Institution undergoes routine financial audits

    • Institution Pharmacy

  • Pharmacy on site
  • Pharmacy has secure, limited access storage area with daily temperature monitoring and backup generator
  • Pharmacy has standard processes in place to ensure proper receipt, handling, and storage of investigational study drug/vaccine and comparators
  • Pharmacy has standard processes in place to ensure proper dispensing
  • Pharmacy has standard processes in place to ensure proper labeling that maintains the study blind
  • Pharmacy has standard processes in place to ensure proper drug/vaccine accountability, retrieval, and return or destruction of unused product
  • Institution has a secure, limited-access investigational drug/vaccine storage area with daily temperature monitoring
  • Institution’s pharmacy has a backup generator sufficient to run necessary equipment, refrigerators, freezers, etc.

    • Institution Equipment

  • Protocol for managing anaphylactic shock
  • Institution has a blood bank
  • Institution carries out blood transfusions for patients that need it
  • Functioning IV infusion pumps
  • Functioning basic life support equipment (crash cart)
  • Functioning electrocardiogram (EKG)

    • Availability of banked blood at institution:

  • Always available
  • Occasionally available
  • Rarely available

    • Institution performs the following routine blood screening tests on banked blood:

  • HIV
  • HBV
  • HCV
  • HPV
  • HTLVI
  • HTLVII
  • Syphilis

    • Additional information:

  • Institution’s equipment is calibrated and maintained per manufacturer’s guidelines
  • Institution’s equipment calibration and maintenance is documented
  • Institution’s laboratory has a secure, limited access biological specimen storage area with daily temperature monitoring
  • Institution’s laboratory has a backup power source, with alarm, sufficient to run necessary equipment, refrigerators, freezers, etc.
  • Institution maintains and uses a diagnostic imaging protocol manual
  • Laboratory maintains and uses a laboratory protocol manual
  • Laboratory maintains and uses a laboratory protocol manual

    • Program-Specific Capabilities

    Institution Cancer Treatment Capabilities and Equipment

  • Treats cancer patients
  • Performs surgical excisions
  • Administers chemotherapy
  • Uses radiation therapy

    • Radiotherapy machines on site:

  • Linear accelerator
  • Cobalt 60
  • Brachytherapy machine

    • Institution Infectious Disease Treatment Capabilities and Equipment

  • Treats infectious disease patients
  • Protocol for managing sepsis

    • Vaccines administered on site:

  • Measles
  • Meningitis
  • Ebola Vaccine Trial
  • Rabies
  • HPV
  • Influenza
  • Polio
  • Tetanus
  • Rotavirus

    • Infectious disease treatment services performed on site:

  • Antimicrobial/antibiotic drugs (small molecules or biologics; including antibacterial, antifungal, antiparasitic, antiviral medicines)
  • Immunotherapies: COVID-19 Immunotherapies
  • Supportive care/symptom management
  • Surgery
  • Viral load monitoring

    • Investigators at University Clinical Research Center

    Sounkalo Dao, M.D.

    Professor, Faculty of Medicine and Odontostomatology, University of Sciences, Techniques, and Technologies of Bamako; University Clinical Research Center

  • Infectious Diseases

    • Overview

    Prof. Sounkalo Dao is a Professor in the Faculty of Medicine and Odontostomatology at University of Sciences, Techniques, and Technologies of Bamako, where he is also affiliated with the University Clinical Research Center. He has published on tuberculosis and cryptococcosis coinfection; antiretroviral therapy for HIV infection; and gut microbiota interactions. His clinical trial interests and experience include drug (small molecule) and observational studies of COVID-19, Ebola virus disease, HIV, Lassa fever, measles, tuberculosis, unexplained febrile illnesses, and Zika virus disease. Prof. Dao is the principal investigator for an observational clinical trial examining the epidemiology and clinical characteristics of emerging and re-emerging infectious diseases with epidemic potential in Mali.

    Trial Phases

  • Phase IV

    • Experience Conducting or Participating in Clinical Trials: Yes

    Previous Clinical Trials

    https://clinicaltrials.gov/study/NCT05441800

    https://clinicaltrials.gov/study/NCT00867048

    Mahamadou Diakite, Pharm.D., DPhil

    Vice Chancellor, Professor of Immunogenetics, and Head, Laboratory of Immunogenetics and Parasitology, Malaria Research and Training Centre, University of Sciences, Techniques and Technologies of Bamako (USTTB); Deputy Scientific Director, University Clinical Research Center, USTTB

  • Infectious Diseases

    • Overview

    Prof. Diakite is Vice Chancellor, Professor of Immunogenetics, and Head of the Laboratory of Immunogenetics and Parasitology at the Malaria Research and Training Centre, and the Deputy Scientific Director at the University Clinical Research Center. His clinical trial interests and experience include drug (biologic and small molecule), genomic epidemiology, immunogenetic, and vaccine studies for Ebola virus disease, hepatitis B, and malaria. He is committed to developing genomic research in Mali through collaborations, training, and provision of statistical and epidemiology support. As principal investigator or co-investigator on several previous grants (funded by the International Center for Excellence in Research [ICER-Mali], U.S. National Institutes of Health [NIH], and other organizations), Prof. Diakite (1) developed effective measures of infectious disease patterns; (2) established strong ties with local communities to enable recruitment and tracking of genomic data over time in accordance with international ethical standards; and (3) established analysis pipelines to process whole genome Plasmodium falciparum data. He is currently co-leading the analysis on the Artemisinin Resistance Project in Kenieroba, Mali. He is also conducting longitudinal and epidemiologic analyses of innate and acquired immune responses and resistance to malaria in Malian children and adults, including the relationship of human genetic polymorphisms to malaria pathogenesis.

    Formal Clinical Trial Training*

  • Formal GCP Training
  • Formal GCLP Training
  • Formal HSP Training

    • Trial Phases

  • Phase II
  • Phase III

    • Experience Conducting or Participating in Clinical Trials: Yes

    Previous Clinical Trials

    https://clinicaltrials.gov/study/NCT02876328

    https://clinicaltrials.gov/study/NCT00146718

    Seydou Doumbia, M.D., Ph.D.

    Director, University Clinical Research Center; Dean, Faculty of Medicine and Odontostomatology, University of Sciences, Techniques, and Technologies of Bamako

  • Infectious Diseases

    • Overview

    Prof. Seydou Doumbia is Director of the University Clinical Research Center and Dean of the Faculty of Medicine and Odontostomatology at University of Sciences, Techniques, and Technologies of Bamako. He has expertise in epidemiology and infectious diseases, including emerging infectious diseases, HIV, Lassa fever, malaria, and neglected tropical diseases. He is epidemiology project leader of the Tulane-West and Central Africa International Center of Excellence in Malaria Research (ICEMR), a consortium funded by the U.S. National Institutes of Health (NIH) and National Institute of Allergy and Infectious Diseases (NIAID), using population-based approaches to malaria research and control. Prof. Doumbia is also funded by the World Health Organization Special Programme for Research and Training in Tropical Diseases (WHO/TDR) to provide an evidence base for integrated malaria control strategies in Niger, Cameroon, and Kenya. In collaboration with NIAID’s Laboratory of Malaria and Vector Research, Prof. Doumbia is co-leader of a leishmaniasis research program aimed at understanding mechanisms of disease resistance/susceptibility in the population living in endemic areas of Mali, to guide vaccine development. His clinical trial interests and experience include drug (small molecule), epidemiological, observational, and pediatric studies of Lassa fever and malaria. Prof. Doumbia previously served as the site investigator for a clinical trial examining COVID-19 vaccine hesitancy, and is currently the principal investigator of an open-label, two-arm cluster randomized controlled trial comparing the effects of attractive targeted sugar baits (ATSBs) + long-lasting insecticide-treated nets (LLINs), vs. LLINs alone (standard of care), on malaria incidence among people aged 5 to 14 years in Mali.

    Trial Phases

  • Phase III

    • Experience Conducting or Participating in Clinical Trials: Yes

    Previous Clinical Trials

    https://clinicaltrials.gov/study/NCT04149119?term=Seydou%20Doumbia&rank=2

    https://clinicaltrials.gov/study/NCT04149106?term=Seydou%20Doumbia&rank=3

    https://clinicaltrials.gov/study/NCT03783143?term=Seydou%20Doumbia&rank=5

    *Definitions

    • HSP – Human Subjects Protection
    • GCP – Good Clinical Practice
    • GCLP – Good Clinical Laboratory Practice