Serious Adverse Event Reporting Systems

TII develops comprehensive pharmacovigilance solutions for clinical trial safety, post marketing safety surveillance and risk management programs. Our solutions provide visibility into safety data throughout the project lifecycle and maximize the efficiency of sponsor, Contract Research Organization (CRO) and site personnel. Companies with established pharmacovigilance departments are freed to evaluate safety information rather than gather it with our scalable, easy to use solutions.

TII can centralize and standardize the collection of Serious Adverse Events (SAEs) across multiple projects, multiple protocols and multiple CROs around the world simplifying the data collection process.

Our customized reporting and automated email notifications allow for each SAE to be assessed quickly and accurately to determine if it meets the criteria for a 7-day expedited report or suspected unexpected serious adverse event reports (SUSAER). It also increases visibility into potential safety signals during clinical trials, when the opportunity exists to proactively examine the issue.