OFF-X release information

New clinical trial metadata and filters; seamless navigation to Cortellis Trials Intelligence; improvement of the OFF-X Drug Score; all FDA labels since 1965.

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Enhanced coverage of discontinued drugs; New content added to Secondary Pharmacology Panels; Updated Safety Maps; 200 FDA labels approved between 1980-1999; Updated links to ChEMBL from drug records.

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Viral vector-centric safety assessment of gene therapies; Updated and enhanced PubMed text mining data to complement curated safety alerts; Completion of the manual curation of the archive of PMDA drug approval packages.

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Causality metadata & filter to identify treatment-related adverse events; Frequencies of adverse events; Safety data of vaccines approved by the FDA and EMA; Enhancement of the Secondary Pharmacology Panels tool.

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New analytics page grouping the analytic tools by use case; New header, sub-header and search bar; Enhancement of the Drug Label Analyzer tool; Text mining results from FDA Summary Basis of Approval documents shown by default in all views.

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Links to clinicaltrials.gov; Clinical trial record to access different publications covering the same clinical study; Improvement of the OFF-X Drug Score; Webinars and recorded training sessions

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Further integration of the RWE Analysis Dashboard in pharmacovigilance use cases; Shortcut to FDA Summary Basis of Approval documents; Expanded drug mapping between OFF-X and Cortellis Competitive Intelligence

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Enhancement of the Safety Alerts section for the assessment of PV signals, including SMQ navigation and links to analytics; Enhanced SMQ navigation in the RWE Analysis Dashboard; Expansion of the retrospective coverage of FDA SBA documents.

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Label changes and new adverse events notifications added to Keep Me Posted alerts; OFF-X Drug and Target/Class Score added to the Safety Alerts section; Enhanced filtering functionalities; Retrospective analysis of PMDA approval packages.

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Further integration of safety data extracted from FDA Summary Basis of Approvals (SBA); Enhanced navigation of the FDA SBA text mining results; New filter in the RWE dashboard to exclude adverse events reported in FDA SBAs; Short-cut to the safety alerts of drug’s secondary targets; Seamless navigation between OFF-X and other Clarivate products.

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Customization of the alerts sent to the user’s mailbox; New analytics to allow the comparison of the safety profile of drugs and their targets; Integration of safety data extracted from FDA Summary Basis of Approvals via text mining methods.

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New Comparative Target Safety Evidence tool to easily assess the safety liabilities associated with the pharmacological modulation of different targets

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Usability enhancements with new filter options to quickly identify the adverse events of interest; Comparative Drug Safety Evidence and Master view heatmaps enhancements; FAERS and JADER content update.

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Comparative Drug Safety Evidence view enhancements and content updates (Safety Maps and Real World Evidence dashboards)

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New Real World Evidence analysis dashboard including reports from FAERS and JADER databases to validate and analyze potential pharmacovigilance signals.

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