At I & I Research, we understand that the safety of patients and the integrity of your clinical data are paramount. Our pharmacovigilance services are designed to manage every aspect of clinical safety with meticulous attention to detail, ensuring that your study meets all regulatory requirements while prioritizing patient well-being. Whether you’re a biotech company embarking on your first clinical trial or a global pharmaceutical leader managing a complex portfolio, our tailored services offer the expertise and support you need at every stage of the drug development process. 

Study-Specific Safety Services 

Our dedicated pharmacovigilance team manages the entire clinical safety process, from the initial triage of adverse events to the final submission of safety reports. We operate within a robust framework of standard operating procedures (SOPs) and study-specific safety plans, ensuring that every aspect of safety management is conducted with precision and compliance. 

Portfolio Safety Services 

As your clinical program expands, managing safety data across multiple studies becomes increasingly complex. Many of our clients start with a safety database at the study level and later transition to a global safety database for their entire portfolio. By consolidating all safety data into a single, centralized database, we can optimize signal detection, enhance risk/benefit assessments, and streamline reporting processes. 

Consultancy Services 

Even the most experienced safety teams can benefit from specialized support. Our pharmacovigilance experts collaborate with our regulatory and medical writing teams to offer flexible, tailored consultancy services that address your specific needs, whether you’re preparing for an inspection, updating your SOPs, or conducting a risk assessment. 

Why Choose I & I Research? 

At I & I Research, we pride ourselves on our ability to provide customized pharmacovigilance solutions that align with the unique needs of each client. Our experienced team is committed to delivering high-quality services that enhance patient safety, ensure regulatory compliance, and support the successful development of your products. With our global reach and local expertise, we are your trusted partner in navigating the challenges of clinical safety and pharmacovigilance. 

Let us help you protect your patients and your product’s future. Reach out to I & I Research today to learn more about how our pharmacovigilance services can support your clinical research efforts.