At Complete Phase, we deliver comprehensive clinical trial pharmacovigilance services to safeguard patient safety and regulatory compliance—from adverse event intake through aggregate safety reporting.
As your dedicated clinical trial partner, we integrate adverse event processing, safety signal detection, risk-based pharmacovigilance, and aggregate reporting into an end-to-end safety monitoring model. Our TGA-compliant workflows and rapid SAE escalation ensure audit-ready deliverables that meet FDA, EMA, and global health authority requirements.
Our pharmacovigilance specialists manage all aspects of safety reporting—triage, coding, and validation of adverse event (AE) and serious adverse event (SAE) data. We comply with TGA requirements under the CTN/CTA scheme, DSUR preparation, and HREC reporting standards to deliver timely, audit-ready documentation that minimizes regulatory queries and keeps your trial on track.
Effective pharmacovigilance relies on stakeholder readiness. We deliver tailored safety training—ranging from investigator induction to sponsor refreshers—covering AE reporting, case narrative writing, and PV best practices. Our team aligns with sponsor needs to provide leading-edge programs that ensure vigilance, compliance, and confidence throughout your study.
We manage the preparation, review, and submission of Development Safety Update Reports (DSURs) and Annual Safety Reports in line with TGA CTN/CTA requirements, while also supporting IND Annual Reports for global programs. By compiling AE trends, benefit-risk assessments, and regulatory narratives, we ensure seamless reporting and compliance.
Our risk assessment team conducts continuous safety profile monitoring and signal detection, leveraging quantitative analyses and medical review to update your product’s risk-benefit evaluation. Proactive risk-based pharmacovigilance identifies safety signals early and informs mitigation plans that protect participants and data integrity.
Effective pharmacovigilance depends on stakeholder readiness. We deliver tailored safety training programs—from investigator induction to sponsor refresher sessions—covering AE reporting, case narrative writing, and PV best practices to ensure compliance throughout your study. From induction to refresher training, our team adapts to sponsor needs to provide highly effective, leading-edge training..
With over 50 years of collective experience in oncology clinical trials and early-phase safety management, Complete Phase combines deep pharmacovigilance expertise with agile execution. As your trusted clinical trial partner, we embed proactive communication, bespoke safety workflows, and veteran leadership into every engagement. From first AE intake to final DSUR submission, our collaborative approach ensures rigorous compliance, rapid signal detection, and scientific excellence.
Explore our other areas of expertise, including Clinical Operations, Medical Affairs, Biometrics, and Local Representative services, to streamline your Phase 1 & Phase 2 clinical trials in Australia & New Zealand.
Ready to elevate your safety strategy?