Oncology Drug Safety & Pharmacovigilance Services

Oncology drug safety is not a back-office function. The adverse event profiles of oncology therapies — particularly immunotherapies, targeted agents, and combination regimens — are complex, often overlapping with disease symptoms, and subject to evolving regulatory guidance. Pharmacovigilance in oncology requires scientific judgment alongside operational discipline.

Sitero’s drug safety and pharmacovigilance team provides end-to-end safety services for oncology programs, from individual case management through aggregate reporting and signal detection.

Case Management for Complex AE Profiles

Oncology adverse events frequently require medical judgment to assess causality, severity grading using CTCAE, and expectedness against an evolving Investigator’s Brochure. Sitero manages end-to-end case processing with medically trained reviewers experienced in oncology AE assessment. This includes SAE intake, narrative writing, causality assessment, and submission to regulators and ethics committees within required timeframes.

Aggregate Reporting and Safety Submissions

Sponsors advancing oncology programs need Development Safety Update Reports (DSURs), Periodic Safety Reports, and other aggregate submissions prepared to regulatory standards. Sitero’s pharmacovigilance team handles aggregate reporting as part of ongoing safety oversight, not as a standalone deliverable disconnected from case-level data.

Signal Detection and Literature Monitoring

Oncology safety signals can emerge from the trial itself, from the published literature, or from other programs in the same class. Sitero’s signal detection and literature monitoring capabilities ensure that emerging safety information is captured, assessed, and acted on within the governance framework of the program — particularly important for novel mechanisms and combination regimens.

Regulatory Readiness as the Baseline

Oncology programs pursuing accelerated pathways — Breakthrough Therapy, Accelerated Approval, Priority Review — require pharmacovigilance operations that are ready for regulatory scrutiny at any point. Sitero designs safety programs with regulatory readiness as the starting point, not a late-stage retrofit.

Local PV Representation

For sponsors running global oncology trials across Sitero’s 67+ country footprint, local pharmacovigilance representation is required in many jurisdictions. Sitero provides local PV representation to support global safety obligations, reducing the complexity of managing country-specific requirements across a multi-country program.

Integrated Safety and Clinical Operations

For sponsors using Sitero as both CRO and safety partner, pharmacovigilance and clinical operations share the same program context. Safety signals are assessed with direct visibility into protocol history, site activity, and medical monitoring data — reducing the communication gaps that occur when safety and operations are managed by different vendors.