pharmacovigilance services

Safety Signal Detection Application and Tools

Safety signal detection plays a crucial role in monitoring and maintaining a drug safety profile – the rapid identification of potential unwanted side effects to protect patient safety is a key component in the current clinical safety and pharmacovigilance.

Monitoring and assessing clinical and postmarketing data has been a lengthy and complex process. Each year, millions of AE cases have been reported to and processed globally by biopharmaceutical companies, and global regulators are imposing increasingly strict safety reporting and risk management guidelines. Finding potential new drug-induced signal or a complex pattern really can be compared to looking for a needle in a haystack. But with the right signal detection strategies, tools and, most importantly, the right experts in place, companies can substantially strengthen and development comprehensive and efficient signal detection systems and processes for faster, more efficient and proactive early safety signal detection.

PPS’s distinguished signal detection strategies and expert services can provide you a better way you maintain your products’ safety profiles and perform evidence-based risk management.

Clinical Trials Signal Detection

Detecting potential safety problems early in the pre-marketing clinical trial stage is critical for clinical development of a new drug. Recent withdrawals of approved drugs in some global markets have increased regulatory attention to carefully evaluation of a drug’s safety profile prior to approval. Use well designed clinical databases high quality and completeness of clinical information for more effectively for signal detection has become a major priority for many biopharmaceutical companies.

PPS can help you to design a clinical study safety system to integrate all available clinical safety data from clinical trials into a CDISC SDTM-compliant data repository and performs automated screening for potential safety issues. This customized system targeted your needs can provide an effective means for proactively detecting potential safety problems early in the pre-marketing clinical trial stage, and can improve your understanding of a drug’s safety profile earlier in the development cycle.

  • Clinical Trial Database for Signal Detection
  • Clinical trial data has typically not been amenable to safety data mining techniques due to small sample sizes narrow variations in database designs. However, the high quality and completeness of clinical information available from trial databases make these sources particularly rich in information and the availability of data standards now makes it possible to use these databases more effectively for signal detection. The promise of gaining deeper knowledge from clinical trial databases is enormous.

  • Graphical, Tabular and Statistical Application Tools
  • PPS can help you to develop graphical, tabular and statistical tools to assist clinical safety staff in examining, analyzing and classifying potential signals prior to drug approval. These graph tools can highlight adverse event terms with higher than expected counts for patients treated with a study drug.

    Events that occur with higher than expected frequency for a comparator or placebo group will also be highlighted, helping reviewers prioritize investigational efforts. This tool also groups the adverse events into MedDRA System Organ Classes (SOCs) to align with the current regulatory requirement for safety reporting and filing.

Post-marketing Signal Detection

PPS has an established expert team for development of safety signal detection system and tools that provide a dynamic, visual data mining environment for detecting signals, uncovering patterns and recognizing emerging trends in the post-marketing spontaneous adverse event report data. As your valuable safety expert partner, PPS gives global pharmacovigilance professionals – whether in industry or government – the expertise and necessary system and tools they need to effectively manage the review, processing and response to potential important safety signals expeditiously and efficiently.

  • Advanced Data Mining Techniques
  • PPS signal detection application supports the detection and quantification of safety signals through the use of advanced data mining techniques applied to a variety of spontaneous reporting databases, including a company’s internal safety database. Using the Empirica™ Signal solution, drug safety scientists gain full access to signal scores and to underlying adverse event report data.

    Detailed safety signal identification and analysis from the PPS services can be based on any of the several supported safety databases. These include the FDA’s Adverse Event Reporting System (AERS) and Vaccine Adverse Event Reporting System (VAERS) databases, the Vigibase ADR (adverse drug reaction) database from the WHO Collaborating Centre for International Drug Monitoring, and an organization's home grown proprietary drug safety database.

    We use a wide range of data algorithms, including the MGPS Bayesian data mining algorithm, to produce statistical scores that objectively quantify the frequency with which a drug is occurring with an event. Drugs found to be occurring at disproportionately high rates, even when rarely occurring, can alert reviewers to a potential safety signal, helping prioritize or accelerate further analysis using traditional pharmacovigilance methods.

    In addition, the resulting scores can be presented in tabular or graphical format to allow users to have a quick summary and overview for comparison. Our tools also provide features to investigate specific data: case series, database queries, and standard and user-designed reports.

  • Other Important Features
    • Topic Tracker - allows safety experts to create records of signals and other safety-related topics of interests.
    • Improved drug portal interface - allowing users to review scores in tabular or graphical format and drilldown to the underlying case details
    • The PPS application supports the classical Proportional Reporting Ratio (PRR) and Reporting Odds Ratio (ROR), as well as logistic regression.
mulitple dimensions signal assessment

Signal Management Tool

Once a potential safety signal has been detected with the PPS product, drug safety scientists can use the signal management tool to track and manage the signal, based on review of data retrieved from relevant databases, including company’s own global database.

Although not all potential safety signals identified with the PPS tools and applications represent real safety problems for a drug, proactively monitoring and managing those potential signals with clinical significance over time with periodic data summary review is critical to any ongoing strategic pharmacovigilance programs.

In addition, PPS signal management applications and services offers capabilities to help safety reviewers to systemically track and document the review comments and conclusions of earlier reviews, highlight significant changes in the characteristics over time for monitoring severity and reporting frequency, and organize workflow. These features are critical for companies to compliant with the global regulatory safety reporting requirements and to have a successful outcome during an regulatory health authority or business partner inspection or audit.

PPS application can be used in a 21 CFR 11 compliant environment.