Delivering uniform conduct and quality globally
Running your trial across a number of disparate sites in different countries can create a challenge in ensuring consistent processes for your clinical trial recruitment. With AES Sites & Patients, we use standardized launch processes to ensure consistent data quality regardless of where your site is located. Our study execution includes centralized training and oversight, localized quality control and consolidated supply management, along with territory-specific teams to oversee quality control processes and address potential issues.
We utilize enterprise-level management informatics platforms to monitor trial performance in real time to ensure programs advance in a timely manner while maintaining high quality. The resulting data also inform how we conduct subsequent studies globally. Our quality assurance team conducts risk-based internal site, process and vendor audits and facilitates standard operating procedure maintenance and enhancement. Our territory quality managers engage with site managers and delegated site personnel on quality control.
In more than 1,000 audits conducted over the past few years, AES sites had 50 percent fewer significant findings than non-AES sites. And, we have had no negative enforcement actions following 37 routine inspections during this same time. We are routinely inspected by multiple regulatory authorities, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA).
Standardized launch processes and operating procedures to ensure consistent data quality
You can rely on the quality of our data
Standard launch processes to deliver uniform conduct and quality globally
Territory quality managers who oversee the operational quality of investigator sites related to quality data delivery
Centralized training, oversight and supply management