Pharmacovigilance Systems & Technology
The ability to effectively monitor safety requires a thorough and complete collection of high quality data during the entire product lifecycle. Sophisticated yet versatile technology facilitates the gathering and analysis of data, so risks are detected early and patient safety is maximally protected.
An electronic data capture (EDC) system collects and transfers safety data using gateway solutions. Our highly trained safety specialists operate our signal detection software and permit the review of individual patient profiles and aggregate data. We can inform regulatory authorities and other stakeholders of safety information both electronically and instantaneously. Our electronic tracking system provides transparency of our compliance with global regulations during audits and inspections, far surpassing the limited capabilities of commercially available safety databases. Alternatively, if you prefer to manage critical safety data with your in-house systems, our teams have the know-how to operate in your environment. For those sponsors who prefer to meet safety needs with a less technological approach, PRA will seamlessly employ processes to effectively and accurately meet your pharmacovigilance needs.
Efficient technology operated by expert staff enables PRA to offer effective pharmacovigilance solutions.
Whether you prefer a high tech or a low tech approach, PRA believes that success lies in the skills and fortitude of the operator. The dedication and knowledge of our teams is second to none, reinforcing our core belief that we must first and foremost be patient-centered in all aspects of our clinical trials. Together, we can customize a safety solution tailored to your specific needs.