From licenses and evolving safety and pharmacovigilance requirements to risk minimization and generating evidence in special populations, our post-marketing surveillance services keep you moving at the speed of science, even after commercialization.
When combined with our collaborative approach, our post-approval solutions have everything you need to succeed:
We use a modern, highly regulated safety database system to track and report drug side effects, which follows international rules for how safety data must be formatted and submitted, and is fully validated to meet strict US electronic record regulations.
Our vigilant central monitoring helps improve quality, increase participant safety, and ensure data integrity, reducing the time and cost to reach critical decision points.
We strengthen risk management and EU pharmacovigilance readiness through risk management plan (RMP) and risk evaluation and mitigation strategy (REMS) planning; pharmacovigilance system master file (PSMF); and qualified person for pharmacovigilance (QPPV) support, reducing compliance gaps.
We support global Phase IV registry execution with structured country operations and remote monitoring, maintaining long-term patient engagement, promoting data quality, and enabling efficient observational study delivery across regions.
We provide end-to-end pharmacovigilance and long-term safety surveillance, including clinical trial safety management, post-marketing surveillance and regulatory reporting, and Phase IV/registry execution, spanning data management, monitoring, signal detection, and global compliance support:
Our comprehensive, risk-aware strategy and collaboration promote timely and compliant study execution, maintain compliance and participant safety, and enable timely regulatory submissions.
Count on our team to:
We support a full range of post-marketing pharmacovigilance activities, including AE/SAE case management, expedited and periodic safety reporting, signal detection, literature monitoring, and governance to promote ongoing patient safety and regulatory compliance.
We integrate clinical trial safety and post-marketing surveillance into a single operating model, enabling consistent SAE data capture, standardized coding and evaluation, improved oversight, and cost efficiencies across the product lifecycle.
We support risk management plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS), including development, updates, and operational execution to meet global safety requirements.
We support EU pharmacovigilance requirements including pharmacovigilance system master file (PSMF) maintenance and collaboration with the qualified person for pharmacovigilance (QPPV) to promote regulatory compliance.
We manage global reporting differences by harmonizing core safety processes while adapting outputs to local regulatory requirements, recognizing that expectations vary across countries and health authorities.
We prepare and maintain all key regulatory safety reports, including development safety update reports (DSUR), IND/IDE annual reports, periodic adverse drug experience reports (PADER), and periodic safety update reports (PSUR).
We support EudraVigilance (EVDAS) monitoring through structured workflows designed to enable timely signal detection, case tracking, and regulatory reporting in line with EU requirements.
We maintain long-running Phase IV registries through remote monitoring, structured country operations support, proactive communications, and tracking tools to support engagement, compliance, and data quality over time.
We use validated safety systems such as Argus, compliant with ICH E2B(R3) and 21 CFR Part 11, supported by regular MedDRA updates and integrated reporting tools to deliver high-quality, compliant safety data management.
We prepare sponsors for pharmacovigilance (PV) audits and inspections through a robust quality management system (QMS), providing structured documentation, readiness support, and end-to-end compliance oversight.