Safety Solutions
Proactive Tools to Enable Strategic Pharmacovigilance
The Product Safety Imperative
The growing government and public concern about drug safety has both increased the importance of pharmacovigilance activities and highlighted the limitations of relying entirely on traditional methods such as individual case review. Today’s zero tolerance drug safety environment calls for new strategies to proactively identify and expeditiously manage emerging safety risks.
In this highly competitive and risk-averse environment it is essential for pharmaceutical companies to establish pharmacovigilance programs that capitalize on the best available information from multiple data sources using the most advanced set of tools available for developing a thorough and well understood safety profile.
Phase Forward’s Empirica suite of innovative pharmacovigilance and risk management solutions delivers Adverse Event Reporting, Data Mining, Signal Detection and Signal Management capabilities that help companies identify potential safety problems and manage risk effectively across the full product life cycle. The Empirica suite was designed to help companies manage pharmacovigilance activities strategically.
The Empirica Suite comprises the following products: Empirica Trace, Electronic Case Submissions Module (ECSM), Empirica™ Signal and the Clinical Trials Signal Detection (CTSD™) system. The Empirica Trace software provides comprehensive adverse event data collection, management, and reporting functionality. The system’s companion electronic submission option, ECSM, offers full support for E2B submission of case reports to regulators and receipt of data via E2B standard files. The Empirica Signal product performs data mining using publicly available data for marketed products. The Signal Management module facilitates the ongoing monitoring and tracking of safety signals, such as those identified in Empirica Signal. The CTSD system supports signal detection from clinical trials data as it accumulates during development.
The development of the Empirica suite and related services are managed by Phase Forward’s Lincoln Safety Group, one of the most experienced and respected teams in the industry. Only Phase Forward can offer such a highly skilled and experienced team with a proven track record of working with safety experts in the government and commercial sectors.
As an established and successful public company, Phase Forward offers
the leadership and long term stability that will allow customers to
feel confident that they have selected a lasting partner for the future.
Safety ProductsClinical Trials Signal Detection: CTSD™This award-winning product provides the advanced graphical tools and statistical methodology needed to examine, analyze and evaluate a drug’s safety profile prior to marketing approval. CTSD is built on the WebSDM™ platform, allowing the integration of data into a CDISC SD™-compliant repository for safety screening and profiling with CTSD. read more Strategic Pharmacovigilance: Empirica™ SignalThis cutting-edge technology uses advanced data mining techniques to uncover safety signals in private and public databases, and further enables safety evaluators to monitor their evolution over time, creating a production pharmacovigilance environment. read more Adverse Event Reporting: Empirica™ TraceThis Web-based, high-performance tool enables safety evaluators to track and report on adverse events, providing required documentation for regulatory agencies in the US, EMEA and Japan. Empirica Trace supports safety data management and adverse event reporting for both clinical trials and marketed products. read more |