Clinical Trials Unit (CTU)

The CTU is part of the research support services of the Centro de Investigação em Saúde de Manhiça (CISM). Although the CTU was formally established in 2025, the Centre brings over 20 years of experience in supporting and conducting clinical trials across a wide range of health research areas.

Our aim is to support the conduct of clinical trials in a highly competent and efficient manner, in accordance with the principles of Good Clinical Practice (GCP) and internationally recognised standards of integrity in biomedical research. We are committed to the ethical evaluation of drugs, vaccines, and diagnostic tools while safeguarding the health, safety, and rights of research participants.

CTU

Total Clinical Trials Conducted

The trials conducted cover all phases of clinical development (I, II, III and IV)
Research focused on infectious diseases, including:
- Malaria
- Tuberculosis (TB)
- Human papillomavirus (HPV)
- Salmonella
- COVID-19
Trials evaluating vaccines, drugs, and diagnostic methods
Studies conducted in both pediatric and adult populations
Experience in single-centre and multicentre clinical trials

49 Clinical Trials

Since 2001

Services

Services Provided

Preparation, submission, and follow-up of study documentation to regulatory authorities (ANARME) and ethics committees (CNBS).
Management of protocol amendments, progress reporting, and study close-out.

The clinical component of the CTU provides staff with experience in medical assessments, administration of investigational products, participant follow-up, and adverse event management.
The clinical infrastructure includes facilities for clinical trials in both outpatient and inpatient settings, including:

Rooms for informed consent procedures.
Dedicated spaces for physical examinations, clinical assessments and sample collection.
Rooms for the administration of investigational products.
A short-term pharmacy area to support study-related product handling.
Designated spaces for tuberculosis (TB) clinical trials, designed to meet infection control requirements.

The pharmacy provides full support for clinical trials, including:

Support for investigational product importation, including coordination with sponsors and regulatory authorities to facilitate compliant and timely import processes.
Receipt, storage, preparation, and dispensing of investigational products and comparators.
Systems for temperature monitoring, inventory control, drug traceability, and reconciliation.
Secure documentation and access controls, with contingency plans for deviations or excursions.

Database design, electronic data capture (EDC) management, data entry, validation, query resolution, and analysis-ready datasets.
Compliance with GCP, data protection regulations, and ALCOA+ principles, with systems for audit trails, version control, and secure access.
Accreditation in progress to demonstrate commitment to quality and compliance.

More information is available on the dedicated Data Centre Section.

Centro de Dados

Standard Operating Procedures (SOPs): Comprehensive, approved, and regularly (Biannually or before if needed) reviewed procedures covering all clinical trial activities.
Internal Audits: Two planned internal audits per year to assess compliance, identify improvements, and ensure ongoing readiness for sponsor and regulatory inspections.
Staff Training and Qualification:
- Ongoing training programs to maintain staff competency and awareness of clinical trial-related SOPs.
- Continuous monitoring of GCP training expiry dates, with timely refresher reminders for clinical trial teams.

Structured community and participant engagement strategies to support recruitment, retention, and ethical trial conduct are in place, including:

Use of a Community Advisory Committee to support community mobilisation and foster trust in clinical research.
Participant retention strategies include transportation support, follow-up phone calls, and participant-centred visit management.
Return and dissemination of study results to participants and communities, supporting transparency and long-term engagement.

Team

Tacilta Nhampossa

Coordinator

Inocência Cuamba

Operational Manager

Miguel Bene

Quality Assurance Manager

Lázaro Químice

Pharmacist

Chenjerai Jairoce

Coordinator

Arsénio Nhacolo

Operational Manager

Saquina Cossa

Quality Assurance Manager

Current Clinical Trials

SMAART-MAP - Severe Malaria A Research and Trials Consortium – Multisite Adaptive Platform Trial.

More info

BioNTech - A Phase Ib /II a, two-part, randomized, placebo-controlled, observer-blind, dose-finding evaluation trial to describe the safety, reactogenicity, and immunogenicity of two investigational vaccines against tuberculosis

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TSCV - Age-descending, randomized, placebo-controlled Phase 2 trial in three sites in sub-Saharan Africa to assess the safety and immunogenicity of a parenteral Trivalent Salmonella versus placebo

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CERVAVAC - A phase-IIIb, partially double-blind, randomized, multi-country clinical study to evaluate the immunogenicity, safety, and reactogenicity of SIIPL qHPV vaccine (cervavac®) in women living with HIV aged 15-45 years

More info