|
CLINICAL TRIAL MANAGEMENT SERVICE
- Provide clinical research consulting services to sponsors, Principal Investigators (PI) and dental students who are keen to conduct investigator-Initiated trials (IIT) or sponsored trials.
- Support study feasibility assessments and assist with project agreement(s) in consultation with our legal counsel.
- Generate the costing for the study.
- Assist with the submission of applications to the Centralised Institutional Review Board (CIRB), Domain Specific Review Board (DSRB, NHG IRB), NUS Institutional Review Board and other regulatory boards.
- Plan, organise and implement the study protocol as well as manage research-related finances expenditures, monitor project deliverables and ensure completion of study closeout activities (e.g. submitting study status report to IRB or DSRB, archiving study files etc.).
- Ensure the study protocol complies to the Good Clinical Practice (GCP) Guideline of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and our institutional standard operating procedures.
- Oversee risk management and reporting such as adverse events or serious adverse events to the relevant unit.
|
| |
|
CLINICAL RESEARCH COORDINATION
- Our experienced coordinators are certified as dental nurses. They also hold certificates in Collaborative IRB Training Initiative (CITI) and International Conference for Harmonisation Good Clinical Practice (ICH GCP).
- Assist with subjects’ recruitment and research appointments.
- Assist to perform dental- or research-related procedures and collect specimens.
- Maintaining the Investigator Site File (ISF).
|
 |
| |
|
|
|
DATA MANAGEMENT
- Designing and developing the study database.
- Creating and designing Case Report Forms (CRF) or Data Collection Forms (DCF) in accordance with the requirements of the clinical trial protocol.
- Maintaining the integrity and accuracy of research data through data cleaning and query management.
- Training study team members in data entry to ensure the quality of the study data.
- Manage and review study randomisation.
- Support the study team with electronic Process Automation System (e-PAS) for data extraction, medical records and system access for research purposes and ensure all data collected adheres to the Personal Data Protection Act (PDPA).
|
| |
|
INVESTIGATIONAL PRODUCT (IP) MANAGEMENT
- Draft and prepare the IP management protocol according to the study requirements, ICH GCP and institutional standard operating procedures (SOPs).
- Manage the importation and exportation of IP locally and globally according to ICH GCP and institutional SOPs.
- Oversee IP labelling, dispensing, storage, return and destruction of the study.
- Train study team members on the IP management SOPs and regulation.
|
|
|
|
BIOSTATISTICS SUPPORT
- Data study design and development.
- Statistical analysis planning and programming.
- Statistical report writing and research manuscript preparation.
- Click here to find out more about the service.
|
