Pharmacovigilance solutions at ABRS are supported by a dedicated team of experts in drug safety and pharmacovigilance. Our professionals bring deep therapeutic area knowledge and hands-on experience with adverse event detection, signal evaluation, and benefit-risk assessments. This expertise enables us to detect early safety signals, mitigate risks proactively, and ensure that clinical trials proceed without unnecessary safety interruptions. Sponsors benefit from a team that is fully integrated into their operations but remains accountable to ABRS quality standards, offering the best of both worlds: local execution and global oversight.

Pharmacovigilance solutions include the preparation of detailed safety narratives, aggregate reports such as DSURs and PSURs, and compliance with country-specific reporting requirements. With ABRS, sponsors gain the assurance that safety submissions will be adapted to the regulatory expectations of each health authority, whether in the United States, Europe, Latin America, or Asia-Pacific. Our dual capability—global standardization combined with local adaptation—reduces delays and enhances regulatory confidence in the sponsor’s safety profile.

Pharmacovigilance solutions further extend to marketing authorization holders and post-market surveillance, ensuring continuous monitoring of drug safety once a product reaches the market. Our teams provide vigilance services that track, assess, and report safety signals beyond clinical trials, protecting both patient populations and brand reputation. By maintaining alignment with pharmacovigilance regulations globally, ABRS enables sponsors to navigate the complex landscape of post-market safety monitoring without compromising operational efficiency or compliance integrity.

Pharmacovigilance solutions from ABRS are also future-ready, integrating innovation, automation, and predictive analytics into our safety frameworks. With Python-based automation and data science capabilities, we help sponsors reduce manual effort in case processing, enhance accuracy in safety data analysis, and anticipate potential safety challenges before they become critical. This fusion of human expertise and technological innovation reflects ABRS’s unique positioning as an FSP provider: not only delivering operational resources but also enabling sponsors with tools and insights that elevate the value of pharmacovigilance.

Pharmacovigilance solutions are, above all, a reflection of ABRS’s commitment to being a trusted global FSP partner. By aligning operational delivery with scientific rigor and regulatory compliance, we ensure that sponsors can focus on advancing therapies while we safeguard patient safety. Whether supporting early-stage drug development, managing large-scale international trials, or ensuring post-approval compliance, ABRS provides tailored pharmacovigilance solutions that adapt to the scale and complexity of every study. With our integrated model, sponsors can move forward confidently, knowing their safety oversight is managed by a partner dedicated to excellence, compliance, and patient protection.