Navigating Pharmacovigilance in Complex Clinical Trial Designs-Challenges, Strategies, and Best Practices

Executive Context: why pharmacovigilance must evolve

As clinical trial designs become more innovative, pharmacovigilance (PV) must evolve in parallel. Modern development programs increasingly rely on adaptive and platform trials, basket and umbrella designs, decentralised methodologies, combination regimens, and advanced modalities such as cell, gene, and RNA-based therapies.

While these approaches accelerate development and enable scientific precision, they also introduce new layers of operational, regulatory, and safety complexity. In this environment, pharmacovigilance is no longer a purely reactive or supporting function – it is a critical enabler of trial continuity, regulatory confidence, and patient protection.

---

Regulatory and operational implications

From a regulatory and operational standpoint, complex trials place increased demands on pharmacovigilance organisations. Safety teams must manage greater data complexity, non-standard reporting pathways, extended long-term follow-up obligations, and an increasing need for real-time medical judgment rather than retrospective review.

Despite these challenges, regulatory expectations for patient safety, benefit–risk assessment, and compliance remain unchanged.

Core pharmacovigilance responsibilities — unchanged, but harder to execute

Regardless of trial design, effective pharmacovigilance must consistently deliver:

• End-to-end safety data collection and lifecycle management
• Expedited and periodic safety reporting (e.g., SAEs, SUSARs)
• Ongoing benefit–risk evaluation
• Risk management planning and execution
• DSMB/IDMC coordination and independent safety review
• Clear safety communication with regulators, investigators, and sponsors

The differentiator in complex trials is not what must be done, but how reliably and consistently these responsibilities are executed across evolving study architectures.

Enabling safe, compliant, and agile development

In complex clinical trials, pharmacovigilance must do more than ensure regulatory compliance—it must actively support scientific agility and operational continuity. Robust safety oversight enables sponsors to adapt protocols, incorporate emerging data, and accelerate decision-making without compromising patient protection or regulatory trust.

When medical expertise, advanced analytics, and scalable safety processes are integrated effectively, pharmacovigilance becomes a strategic asset—supporting innovation while safeguarding participants, programs, and development timelines.

Aixial’s integrated approach to safety oversight

Aixial supports complex clinical programs through a centralised, medically led safety oversight model designed for clarity, scalability, and regulatory confidence.

Safety and Vigilance teams operate under harmonized global processes, aligned medical review standards, and clearly defined roles across all contributors. This structure is supported by advanced analytics that enable early signal detection, proactive risk management, and informed decision-making throughout the study lifecycle.

Why sponsors partner with Aixial

Aixial’s Safety and Vigilance Team brings deep experience across complex clinical programs, including global studies, adaptive and platform trials, rare disease programs, combination therapies, and multi-vendor environments.
Sponsors benefit from:

• Global pharmacovigilance expertise and established compliance infrastructure
• Experienced medical safety leadership
• Advanced analytics and real-time safety dashboards
• Integrated safety systems and electronic data capture connectivity
• Automation supporting duplicate detection, quality control, and reporting efficiency

These capabilities are particularly valuable for high-volume or fast-moving studies, where proactive risk mitigation is essential.