The Centre has many units and that include:
Clinical Unit
This consist of 24 beds in 4 cubicles, central nurse station positioned within the unit for easy monitoring of study participants, it has a central physiological monitoring system connecting to bed-head physiological monitors and telemetry system, Surveillance camera system for supporting safety monitoring. It also has a dedicated resuscitation room for medical emergency and has 24-hour support by SUH central resuscitation team and intensive care unit (ICU). It has a surgical Complex Unit and this consists of operating theatre, recovery, sterilisation unit and changing rooms. It has an out-patients clinic, where patients are seen and followed regularly The unit is run by MRC research assistants. The Centre is equipped with a new state of the art Ultrasound machine. The ultrasound machine has the facilities of scanning, recording and storage images. It had improved early case detection of mycetoma and management.
Biological Specimen Management Facility
Two dedicated biological specimen processing rooms with refrigerated centrifuges and biosafety cabinet for supporting two concurrent studies are available. It has a dedicated biological specimen storage room with -20°C and -70°C freezers.
Study Drug Management Facility
The Centre has a dedicated drug storage room with 4°C and -20°C refrigerators for refrigerated drugs), and temperature and humidity-controlled cabinets (for ambient temperature drugs). It has a dedicated drug processing room, for controlled processing of study drugs, with biosafety cabinet for drug reconstitution and electronic balances for dose adjustment. It has an emergency electricity backup, uninterrupted power supply and 24-hour monitoring and alarm system for all refrigerators/freezers. It has regular maintenance/calibration for major equipment system with full documentation
The Quality Assurance and Archive Unit
The Quality Assurance Unit (QAU) is an independent unit reporting to the centre general manager. The main focus of the Unit is to ensure the continuous improvement of its Quality Management System. Through regular monitoring, the Unit ascertains that the required quality fulfillments are met according to the actual GLP-, GCP-, guidelines and internal SOPs.
The quality management involves the following major activities:
- Assuring quality program (planning, conducting and reporting of inspections);
- Preparing annual training schemes, training of personnel;
- Administering and archiving of SOPs;
- Evaluation of the requirements of new guidelines;
- Assisting sponsor audits;
- Auditing (system audit, study audit);
- Assisting authority inspections and answering their queries; and
- Suggesting corrective actions, monitoring and documentation of implementation of corrective actions, and undertaking risk-management.
The quality assurance program entails the following major tasks:
Good laboratory practices (GLP)
- Project independent inspections according to the annual master plan;
- Project dependent inspections of analytical protocols, analytical project performances and analytical reports;
- Preparing inspection reports and follow-up of findings; and
- Preparing of QAU-statement.
Good clinical practices (GCP)
- Conducting system audits in clinic units;
- Performing study audits including study protocol, ICF, CRF and TMF;
- Undertaking study audits during clinical performance;
- Preparing audit reports and follow up of findings; and
- Preparing QAU-statement.
QA staff ensures that projects are executed efficiently with the highest level of quality. Training on system improvement is given on a continuous basis to all personnel involved in the study (and to clients as requested). The QA personnel are required to keep themselves update with the current knowledge in the area. Periodically, staff members are required to attend continuing education programs and participate in QA workshops and conferences, as necessary.
The Data Centre
The Data Centre is responsible for data management; data entry, processing, statistical analysis, data presentation in the form of tables and figures, data storage and retrieval
The Centre has a secured storage system, ensuring all archived study-related documents and stored product samples are retrievable and identifiable. Archiving SOPs are in place, and access to the archive is controlled and restricted to authorised personnel. Storage areas are free from dampness which may cause premature deterioration.
Records are maintained on the internet cloud system and other media. These are subject to “back-up” at regular intervals and stored in a protected location to ensure security from loss/damage of active data. The length of period for which study documents, including raw data and product samples kept in the archive, are defined in the SOPs in compliance with local requirements or international recommendations as appropriate.
The Administration Unit
The Administration Unit is responsible for the overall administration of the organisation and housekeeping. The Unit has many sub-units such as Human Resource, Finance, Public Relations and Marketing and Business Management.
Leisure and Dining Area
A dedicated leisure and dining area for study participants are available, with lockers for keeping study participants’ personal belongings and Internet bar and entertainment facilities.