Headed by Janice Ng Research Monitoring services comprise:
- Coordination and conducting of site initiation visits
- Customisation of project templates in accordance with the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guideline
- Provision of training for investigators and site personnel
- Monitoring of clinical trials according to the monitoring plan in compliance with the approved protocol, regulatory and Institutional Review Board (IRB) requirements, sponsor guidelines and GCP. Monitoring includes source document verification, protocol and GCP compliance checks, safety, operations and essential document review, investigational product and lab sample reviews
- Facilitation of communication with project stakeholders including clients and trial sites
- Close-out visits after the completion of clinical trials with processes ranging from documentation reviews to archival of clinical trial data documents
The Research Monitoring team takes part in both local and international clinical trials, and it is staffed by trained Clinical Research Associates (CRAs) with accreditation from the Association of Clinical Research Professionals. SCRI’s CRAs collaborate closely with internal study teams and external stakeholders, driving the production of quality research data for local and regional clinicians. Our department has diverse experience in the provision of monitoring services for different therapeutic indications, including oncology, infectious disease, metabolic disease and cardiology. Our CRAs are trained to ensure that trials are conducted, recorded and reported in accordance with protocol, SCRI SOPs, GCP and the applicable regulatory and IRB/IEC requirements. Our CRAs undergo certification examinations by the Association of Clinical Research Professionals (ACRP) as part of their career progression. Their continual training ensures constant development of their technical knowledge and monitoring proficiency ahead of an evolving clinical trial landscape. CRAs train investigation site personnel to meet study requirements and also conduct regular site monitoring visits to enhance operational efficiency and consistency of the projects at hand. Our CRAs’ expertise has taken them to countries ranging from Brunei, Hong Kong, Malaysia, Mongolia, Myanmar, New Zealand, Thailand, Philippines, South Korea, Taiwan and Saudi Arabia. The team understands that building rapport with site collaborators is vital to efficiently resolve site issues together. Communication is key so that timely delivery of project plans and milestones are maintained while adapting to guidelines, regulatory requirements, working culture and environment variances. On-site monitoring visits by CRAs ensure that the rights and well-being of trial patients are protected. This is achieved via verification of trial patient data as well as examination of quality compliance to GCP, regulatory requirements, SOP and the approved protocol.