The CRC SGH’s Investigational Drug Service (IDS) started with investigational product (IP) management for bioequivalence (BE) studies since 2013 at Sarawak Heart Centre. In 2015, we formalized our IP management processes with a written workflow for handling IPs for BE studies. Our IDS services officially began in Sarawak General Hospital in 17 July 2018 at our new CRC building. We established the standard operating procedures for IDS activities in the same year, ensuring that all IDS processes are conducted in compliance with the principles of Good Clinical Practice, Good Dispensing Practice, and the Malaysian Guideline for Phase I Unit Inspection & Accreditation Programme.

Our team of pharmacists recognizes the critical role of proper investigational drug management in clinical trials. We provide meticulous and detail-oriented services that streamline the medication management process and minimize errors. Our daily activities include receiving and registering investigational products, monitoring and documenting IP storage temperature, reconciling the IP inventory, and preparing medications for dispensing. Our top priority is patient safety, and we provide comprehensive guidance and information to ensure that patients take their medication safely and effectively. We also monitor patients’ compliance with their trial medication to ensure that they are taking it correctly. Additionally, we provide support to the study team in concomitant medication screening, drug interaction checking, and provide detailed information on pharmacokinetics/pharmacodynamics (PK/PD) and potential adverse effects of the IP. Our team is also responsible for providing training to and overseeing nursing staff for IP administration to ensure they are fully competent and well-informed about the investigational product.

Our IDS team has managed investigational products for 37 clinical trials, ranging from oncology to infectious disease, as of 23 February 2023. We are dedicated to continuing to expand our services and supporting more trials in the years to come. At IDS, we remain committed to delivering exceptional investigational drug management services for clinical trials while prioritizing patient safety and ensuring compliance with regulations and guidelines.