African Institute of Biomedical Science and Technology

Boronia Farm, 911 Chiedza Park, Harare, Zimbabwe

Private Research Institution

Serves Eastern Africa

The African Institute of Biomedical Science and Technology (AiBST) is a private research institution in Harare, Zimbabwe. AiBST focuses on clinical research, mostly at Phase I. The institute has 28 beds and a clinical staff of 16. AiBST has previously hosted clinical trials, including a Phase I trial for breast cancer treatment. AC3T’s cancer clinical trials capacity data show that AiBST performs well across many dimensions. The institute does not treat cancer patients and does not have diagnostic imaging or laboratory capabilities on site. It however has world class genomics and bioanalytic laboratory expertise in next generation sequencing (NGS) and mass spectrometry (LS-MSMS) which it applies in the analysis of samples from clinical studies. It also has strength in clinical study design and data analysis using advanced pharmacometrics methodologies. AiBST is located at Chitungwiza Hospital, a major referral center with these capabilities in Zimbabwe.

Links to previous clinical trials:
https://clinicaltrials.gov/ct2/show/NCT01824940

https://link.springer.com/article/10.1007%2Fs00228-019-02663-8

https://link.springer.com/article/10.1007%2Fs00228-011-1118-0

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:

  • No

    • Institution Regulatory/Research Ethics Committees

    Frequency of meetings: Monthly

    Application turnaround time (IRB/IEC): 5-6 weeks

    Average time from receipt of final protocol to review and approval of study by all relevant committees: 12 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 Good Clinical Practice (GCP)
    -Training in Good Clinical Laboratory Practice (GCLP)
    Research nurseYes
    -Experience in Clinical Trials
    -Training in Good Clinical Practice (GCP)
    -Training in Good Clinical Laboratory Practice (GCLP)
    Research data managerYes
    -Experience in Clinical Trials
    -Training in Good Clinical Practice (GCP)
    -Training in Good Clinical Laboratory Practice (GCLP)
    Quality assurance managerYes
    BiostatisticiansYes
    Database programmersNo
    EpidemiologistsNo
    PathologistsNo
    PharmacistsYes
    -Experience in Clinical Trials
    -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:

  • None

    • Tests performed:

  • 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:

  • N/A

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

  • N/A

    • 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:

  • None

    • Infectious disease treatment services performed on site:

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

    • Investigators at African Institute of Biomedical Science and Technology

    Collen Masimirembwa, Ph.D., DPhil

    Founder, President, and Chief Scientific Officer

  • Cancer
  • Infectious Diseases

    • Overview

    Prof. Collen Masimirembwa is Founder, President, and Chief Scientific Officer at the African Institute of Biomedical Science and Technology. As a world-renowned scientist and biomedical pharmacologist, his pioneering research—spanning cancer (breast, gastrointestinal) and infectious diseases (HIV, schistosomiasis, tuberculosis)—has contributed to the field of pharmacogenomics, particularly in understanding the genetic diversity and drug response of African populations. His clinical trial interests and experience include evaluation of new chemical compounds to discover which ones have the potential to be used as novel, safe, and effective drugs for the African population. Prof. Masimirembwa also investigates the safety and efficacy of drugs already in clinical use, with a view to optimize treatment outcomes by addressing clinical pharmacology issues such as drug-drug and drug-gene interactions.

    Formal Clinical Trial Training*

  • Formal GCP Training
  • Formal GCLP Training

    • Trial Phases

  • Phase I
  • Phase IV

    • Experience Conducting or Participating in Clinical Trials: Yes

    Previous Clinical Trials

    Publication: Nleya L, Thelingwani R, Li XQ, Cavallin E, Isin E, Nhachi C, Masimirembwa C. The effect of ketoconazole on praziquantel pharmacokinetics and the role of CYP3A4 in the formation of X-OH-praziquantel and not 4-OH-praziquantel. Eur J Clin Pharmacol. 2019 Aug;75(8):1077-1087. doi: 10.1007/s00228-019-02663-8. Epub 2019 May 15. PMID: 31089768.

    Publication: Marasanapalle VP, Masimirembwa C, Sivasubramanian R, Sayyed S, Weinzierl-Hinum A, Mehta D, Kapungu NN, Kanji C, Thelingwani R, Zack J. Investigation of the Differences in the Pharmacokinetics of CYP2D6 Substrates, Desipramine, and Dextromethorphan in Healthy African Subjects Carrying the Allelic Variants CYP2D6*17 and CYP2D6*29, When Compared with Normal Metabolizers. J Clin Pharmacol. 2024 May;64(5):578-589. doi: 10.1002/jcph.2366. Epub 2023 Oct 25. PMID: 37803948.

    Publication: Kanji CR, Nyabadza G, Nhachi C, Masimirembwa C. Pharmacokinetics of Tamoxifen and Its Major Metabolites and the Effect of the African Ancestry Specific CYP2D6*17 Variant on the Formation of the Active Metabolite, Endoxifen. J Pers Med. 2023 Jan 31;13(2):272. doi: 10.3390/jpm13020272. PMID: 36836506; PMCID: PMC9961245.

    *Definitions

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