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 Safety Reporting specialists manage all aspects of pharmacovigilance services—triage, coding, and validation of adverse event (AE) and serious adverse event (SAE) data. We adhere to DSUR, DSUR preparation, and IND Annual Report guidelines to deliver timely, audit-ready safety documentation that minimizes regulatory queries and keeps your trial on track.
Effective pharmacovigilance hinges on stakeholder readiness. We design and deliver tailored safety training programs—from investigator induction to sponsor refresher sessions—covering AE reporting processes, case narrative writing, and pharmacovigilance best practices to maintain vigilance and compliance throughout your study.From induction training to refresher training, our team aligns to the sponsor’s needs to deliver highly effective leading-edge training.
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.
We oversee the preparation, review, and submission of Development Safety Update Reports (DSURs), IND Annual Reports, and Annual Safety Reports to the TGA. By compiling global AE trends, benefit-risk assessments, and regulatory narratives, we ensure seamless aggregate reporting and regulatory alignment.
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?