Standing Ready. Worldwide.
PharmaNet/i3 Strategic Resourcing Safety and Pharmacovigilance team supports clinical trials and post-marketing safety surveillance. Working globally, PharmaNet/i3 Strategic Resourcing can provide integrated or stand-alone services to support product safety monitoring in compliance with regulatory requirements for safety surveillance in pre- and post-approval settings.
PharmaNet/i3 Strategic Resourcing has the flexibility and experience to deliver, whether our clients’ needs are best met on a project-by-project basis, through a functional service provider or consultative relationship. Currently, we have 32 active partnerships with clients; seven of them focused specifically on pharmacovigilance. Our global, integrated team of skilled professionals has deep expertise in direct patient care and industry-specific pharmacovigilance services are highly experienced in drug safety, pharmacovigilance, and pharmacoepidemiology and understand the changing regulatory environment. We have the capability to submit expedited and aggregate reports globally.
Our staff can handle all varieties of global submissions and submit them electronically or via fax, courier or hand delivery, as is required in Argentina.
Clinical Trials Services
To manage clinical-trial safety, the team provides qualified medical analysis and review of all Serious Adverse Events (SAEs), and creates the necessary 21 CFR Part 11-compliant materials for submission to US and international regulatory authorities and data safety monitoring boards (DSMBs). Services include:
With regulatory authorities placing an increased emphasis on risk assessment for marketed drugs, companies can no longer rely solely on periodic reports that list adverse events (AEs). Regulatory authorities today expect greater assessment and analysis of AEs, as well as recommendations for increased safety surveillance monitoring to achieve earlier signal detection. To assist companies during post-marketing surveillance, the Global Safety and Pharmacovigilance team: