Centro de Investigação em Saude de Manhiça

HRR4+H8C Manhiça Maputo, 1929, Mozambique

Private research institution

Serves Eastern Africa

The Centro de Investigação em Saude de Manhiça (CISM) is a private research institution in Maputo, Mozambique. CISM focuses on biomedical research and has a research partnership with the University of Barcelona and other groups, including the European & Developing Countries Clinical Trials Partnership (EDCTP). The institute has a clinical staff of 171. CISM has previously hosted clinical trials, including Phase II and III drug trials for malaria. AC3T’s cancer clinical trials capacity data show that CISM performs well across many dimensions. The institute does not treat cancer patients nor has a pharmacy, but does have laboratory capabilities. CISM has additional areas of strength in pediatric oncology, malaria, and causes of death in addition to its morbidity surveillance platform and demographic surveillance system.

Links to previous clinical trials:

https://clinicaltrials.gov/ct2/show/NCT02698748

https://clinicaltrials.gov/ct2/show/NCT01464138

https://clinicaltrials.gov/ct2/show/NCT00231452

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
  • Epidemiological
  • Diagnostic
  • Drug
  • 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: Monthly

    Application turnaround time (IRB/IEC): 2-4 weeks

    Average time from receipt of final protocol to review and approval of study by all relevant committees: 12-24 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 typeNumber of staff
    Performs study site coordination and manage daily operational activities0
    Prepares and administers study drug0
    Collects and processes study data and maintain data integrity7
    Monitors site processes and ensures quality3
    Biostatisticians1
    Database programmers7
    Epidemiologists6
    Pathologists0
    Pharmacists1
  • At least one staff member has clinical trials experience
  • At least one staff member has HSP training
  • At least one staff member has GCP training
  • At least one staff member has GCLP training

    • Institution Diagnostic Capabilities

  • Institution has personnel capable of performing diagnostic biopsies

    • Biopsies performed on-site:

  • Pleural tap
  • Abdominal tap
  • Lumbar puncture (spinal tap)

    • 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:

  • Good Laboratory Practices (GLP)
  • International Organization for Standardization (ISO)

    • Tests performed on-site:

  • Complete blood count (CBC) with differential
  • Comprehensive metabolic-chemistry panel (CMP)
  • Routine urinalysis
  • Antibiotic sensitivity
  • Bacterial culture
  • Flow cytometry
  • Histology
  • Immunohistochemistry
  • Microscopy

    • 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:

  • 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
  • Site documents all procedures conducted and the results

    • 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

    • Institution Infectious Disease Treatment Capabilities and Equipment

    Data collection in progress

    Investigators at Centro de Investigação em Saude de Manhiça

    Pedro Aide, M.D., Ph.D.

    Scientific Director

  • Infectious Diseases

    • Overview

    Dr. Pedro Aide is Scientific Director at Centro de Investigação em Saude de Manhiça. In addition to his M.D. and Ph.D. (public health) degrees, he has a master’s degree in epidemiology and biostatistics. He was named the inaugural Alan J. Magill Fellow by the American Society of Tropical Medicine & Hygiene in 2017. Dr. Aide’s research and clinical trial interests and experience include small-molecule drug (treatment and preventive mass drug administration), pediatric, and vaccine studies for malaria.

    Trial Phases

  • Phase II
  • Phase III

    • Experience Conducting or Participating in Clinical Trials: Yes

    Previous Clinical Trials

    https://pubmed.ncbi.nlm.nih.gov/31708182/

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6137111/

    https://pubmed.ncbi.nlm.nih.gov/21443960/

    Inácio Mandomando, Ph.D.

    Coordinator, Diarrheal Disease Research Area

  • Infectious Diseases

    • Overview

    Dr. Inácio Mandomando is the Coordinator of the Diarrheal Disease Research Area at Centro de Investigação em Saude de Manhiça. In addition to his Ph.D. (biomedical sciences – microbiology), he has a bachelor’s degree in veterinary medicine. Dr. Mandomando’s research and clinical trial interests and experience include drug (small molecule), pediatric, and vaccine studies for diarrheal diseases, other invasive bacterial diseases, and malaria. He is the principal investigator of the CHAMPS project in Mozambique.

    Trial Phases

  • Phase I
  • Phase III
  • Phase II

    • Experience Conducting or Participating in Clinical Trials: Yes

    Previous Clinical Trials

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3165288/

    https://pubmed.ncbi.nlm.nih.gov/21079803/

    https://pubmed.ncbi.nlm.nih.gov/21443960/

    https://clinicaltrials.gov/study/NCT05124691

    https://clinicaltrials.gov/study/NCT05784701

    https://inclinicaltrials.com/child-only/NCT06422338/

    Tacilta Nhampossa, Ph.D., MBBS

    Pediatrician and Coordinator, Maternal and Child Research Area

  • Infectious Diseases

    • Overview

    Dr. Tacilta Nhampossa is a Pediatrician and Coordinator of the Maternal and Child Research Area at Centro de Investigação em Saude de Manhiça. In addition to her Ph.D. (medicine) and MBBS degrees, she has a Master of Public Health (MPH) degree. Dr. Nhampossa’s research and clinical trial interests and experience include HIV testing, treatment, and prevention, especially focused on pregnant women and children; small-molecule drug trials for malaria; and epidemiological studies of diarrheal and antimicrobial-resistant diseases.

    Formal Clinical Trial Training*

  • Formal GCP Training

    • Trial Phases

  • Phase IV

    • Experience Conducting or Participating in Clinical Trials: Yes

    Previous Clinical Trials

    https://pubmed.ncbi.nlm.nih.gov/34815285/

    https://pmc.ncbi.nlm.nih.gov/articles/PMC3398260/

    https://www.careacross.com/clinical-trials/trial/NCT06281119

    Francisco Saúte, Ph.D., MBBS

    Director General, Centro de Investigação em Saude de Manhiça; Lecturer in Epidemiology, Universidade Eduardo Mondlane

  • Infectious Diseases

    • Overview

    Dr. Francisco Saúte is the Director General of Centro de Investigação em Saude de Manhiça, and Lecturer in Epidemiology at Universidade Eduardo Mondlane. In addition to his Ph.D. (malaria epidemiology) and MBBS degrees, he has a master’s degree in infectious disease epidemiology. Dr. Saúte’s clinical trial interests and experience include behavioral, drug (small molecule), epidemiological, genomic, prevention, vaccine, and vector control studies for malaria. He has also conducted research on SARS-CoV-2 impacts on malaria and HIV.

    Trial Phases

  • Phase II
  • Phase III

    • Experience Conducting or Participating in Clinical Trials: Yes

    Previous Clinical Trials

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9942013/

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6137111/

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7819201/

    Esperança Sevene, Ph.D., MBBS

    Associate Researcher, Centro de Investigação em Saude de Manhiça; Associate Professor of Clinical Pharmacology and Deputy Director for Research and Extension, Universidade Eduardo Mondlane

  • Infectious Diseases

    • Overview

    Prof. Esperança Sevene is Associate Researcher at Centro de Investigação em Saude de Manhiça, as well as Associate Professor of Clinical Pharmacology and Deputy Director for Research and Extension at Universidade Eduardo Mondlane. In addition to her Ph.D. (medicine) and MBBS degrees, she has a master’s degree in pharmacoepidemiology. Prof. Sevene’s research focuses on evaluation of drug and vaccine safety (pharmacovigilance), especially during pregnancy. She has conducted clinical trials involving antimalarials; antiretrovirals; and community and drug interventions for pre-eclampsia and hypertension.

    Trial Phases

  • Phase II
  • Phase III

    • Experience Conducting or Participating in Clinical Trials: Yes

    Previous Clinical Trials

    https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(23)00738-7/abstract

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6700797/

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7471842/

    *Definitions

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