Don’t let case volume and complexity put you at risk. Our end-to-end pharmacovigilance services adapt at the speed of science, enabling compliant safety collection, assessment, and reporting wherever your program goes.
We give you compliant, scalable, and high-quality safety and pharmacovigilance operations across clinical and post-marketing programs worldwide with:
Put the best of the best in pharmacovigilance on your side, from experienced safety scientists and physicians to medical writers with strong clinical backgrounds.
With our structured process and a robust quality management system, you get consistent quality control, audit readiness, and regulatory compliance worldwide.
Count on compliant, efficient, and scalable pharmacovigilance data capture and regulatory reporting with our validated safety systems, robust ICH E2B reporting, real-time monitoring, and managed upgrades.
Operate within your system or ours. Get stand-alone support, full outsourcing, and everything in between. Scale seamlessly.
Our global pharmacovigilance (PV) team comprises safety scientists, physicians, and writers with clinical backgrounds and practice experience. Together, they bring deep expertise in safety operations, data migration, electronic transmission of adverse event information to stakeholders in accordance with ICH E2B standards, reporting, and regulatory compliance. Our services include:
1,000+ studies facilitated. 300+ projects moved to approval.
We offer flexible PV delivery models including full-service outsourcing, standalone functional support, and end-to-end managed solutions, scaling to sponsor needs across programs, geographies, and development stages.
We support leading safety databases, such as Oracle Argus, and can operate within sponsor systems or our validated platforms, depending on your preferred operating model and integration needs.
We deliver end-to-end expedited reporting, including SAE/SUSAR case processing and regulatory submissions, fully compliant with ICH E2B R2/R3 standards and configured for secure electronic transmission to global authorities.
We support full lifecycle safety reporting, including DSURs, IND/IDE annual reports, PSUR/PBRERs, and PADERs, providing accurate, timely, and regulator-ready submissions across global requirements.
We maintain global compliance through regulatory intelligence, country-specific reporting rule configuration, and continuously updated processes aligned with evolving regional clinical trial regulatory requirements and pharmacovigilance standards.
Our PV operations are underpinned by a robust QMS with standardized SOPs, layered quality controls, deviation management, and inspection readiness support to ensure consistent compliance and audit preparedness.
We enable structured signal detection and ongoing safety review through defined governance frameworks, safety review committees, and proactive monitoring cadence to identify and escalate emerging risks early.
Yes, we support advanced therapies including cell and gene therapies, mRNA, and ATMPs, with tailored long-term follow-up strategies and specialized monitoring for complex and evolving safety profiles.
We manage structured PV transitions with clear governance, validated migration approaches, and cutover planning, delivering seamless data migration into centralized safety databases with minimal operational disruption.
We provide full system validation support, regulatory gateway configuration, ICH E2B transmission setup, and robust disaster recovery and backup frameworks to enable secure, continuous PV operations.