Headed by Gao Hong Data Management services comprise:
- Review of all Serious Adverse Events (SAEs) in a study, and performance of safety analysis
- Processing of individual cases and assessment of investigational products
- Safety reporting to regulatory authorities and other stakeholders
- Provision of round-the-clock safety coverage
SCRI’s Pharmacovigilance team plays an essential role in product development, specifically providing safety support to investigator-initiated trials in order to achieve their full potential to provide quality healthcare. The Pharmacovigilance team designs trial-specific SAE forms and safety monitoring plans which establish the safe use of investigational products, reduce risks and increase benefits for patients. In collaboration with principal investigators of a study, the Pharmacovigilance team creates a centralised database to capture and monitor SAEs while ensuring timely identification of events that qualify for expedited reporting if necessary. The team also communicates closely with all site and study teams to provide medical support, consultation on SAE reporting, as well as training for SAE reporting, processes and timeline. Other key services by the Pharmacovigilance team include performing SAE reviews and queries, coordinating with the investigational site to assemble SAE report packages, and carrying out SAE reconciliation. The team is trained in managing the complexities of multi-national and multi-centre trials, such as language and culture barriers, to meet the requirements of international pharmacovigilance regulations. The Pharmacovigilance team safeguards patient safety standards for drugs and medical devices. It delivers the expertise of moving a new drug or device from conception to marketing stages while keeping headcount lean in today’s multifaceted clinical trials.