THE SENTRX PROCESS

Sentrx has deep pharmacovigilance knowledge. But what makes us unique is our ability to consistently package adverse event cases with accurate and complete information. We have carefully blended good clinical practices with operational excellence and information technology talent to create best practices in safety reporting.

Each Sentrx solution is governed by a highly structured methodology for managing the initiation, transition, and operation of your important safety initiatives. Whether you need to standardize clinical trial safety, improve post-marketing safety monitoring, or implement a risk management program, Sentrx ensures regulatory compliance while improving quality, increasing cost effectiveness and reducing processing time.

Active Query
In 2003, the U.S. Food and Drug Administration (FDA) issued the proposed rule on Safety Reporting Requirements for Human Drug and Biological Products. Commonly referred to as "The Tome," this extensive document introduces the process of active query, requiring companies to pursue information on medical error and adverse event cases expeditiously.

At Sentrx, active query is already a valuable service we deliver to our clients. We always have skilled health care professionals available to interact with the initial reporter to collect as much information as possible with a well-defined intake process. When the initial case is incomplete, our Safety Response Center makes outbound calls with a focused line of questioning to determine if a suspected adverse drug reaction (SADR) is serious or non-serious and to obtain the data and supporting documentation needed for medical error and SADR reports.

Active Surveillance and Risk Management
In 2005, the FDA issued three Guidance for Industry documents addressing risk management across the phases of drug development. These papers discussed the use of active surveillance to enhance pharmacovigilance practices and improve the benefit/risk ratio.

Active surveillance is a core competency at Sentrx. We are experts at designing and implementing registries, performing outbound surveys and collecting events of interest that determine how your product is performing in the real world - where pre-existing medical conditions and concomitant medications are the norm.