Drug Safety / Pharmacovigilance (PV)

Here to help your company prepare regulatory-ready serious and non-serious safety reports for both clinical and marketed products, we promise to remain fully compliant with all company-approved operating procedures, at all times; right from the initial event capture, through to submission-ready regulatory forms.

Different to single-case reporting, which involves only individual AE reports, aggregate reporting involves the compilation of safety information for a drug over a period of months or years. An important element of any pharmaceutical business, we’ll ensure that all clinical and marketed periodic reports for planned regulatory response, are developed accurately and efficiently, and include country-specific reports where appropriate.

In pharmacovigilance, signal detection is when adverse reaction data is checked for patterns which might imply that new safety information is required, and more specifically, whether this new information might alter the ration of benefit to risk that is currently associated with the use of a pharmaceutical product. At Agile Scientific, we can confidently and efficiently conduct all or some of the necessary clinical and marketed signal detection and analysis.

Helping us to better understand how many people have a disease or disorder, and how it might affect our society or even our economy, makes epidemiological research extremely important. Our epidemiology consultation service involves overseeing the development of study design, data collection and analysis plans, followed by the preparation of final reports that give a summary of the findings.