Contact Us Support Center Language EN - JP - FR - DE undefined ENNOV PHARMACOVIGILANCE SUITE PV-Reporter Next Generation PV Reporting Software Standard XML e-report generation Individual or batch submission via integrated gateway Multi-lingual paper report creation Easy and flexible data querying and extraction Multiple report formats including aggregate, summary and metrics Full integration with Ennov’s auto-reporting tool Ability to monitor case frequencies, report submission status and more Contact Us The Adverse Event Reporting Challenge On-time, complete and accurate reporting of adverse events is essential for regulatory compliance in Pharmacovigilance. Without proper tools, this rote administrative task can consume your organization’s valuable time and resources. The time spent manually creating regulatory reports, querying data, and formatting outputs might otherwise be directed to higher value activities that can have a material impact on your company’s overall performance. A New Approach to Regulatory Reporting Compliance PV-Reporter is Ennov’s next generation solution for creating and submitting Adverse Event case reports. PV-Reporter is a 100% web-based solution that leverages an elegant and intuitive user interface that instantly generates: Paper report outputs such as CIOMS and MedWatch 3500s. Electronic adverse event reports in full compliance with the ICH E2B standard (R2 and R3 formats). Aggregate listing outputs like PSUR, DSUR, and PBRER Electronic Medical Device AE reports can also be submitted to FDA CDRH in eMDR format. PV-Reporter is easily integrated with any standard AS2 gateway software to manage electronic submissions. Acknowledgment messages and batch submissions are fully supported. PV-Reporter also provides the ability to import E2B compliant XML formats, allowing receipt of submitted cases directly from Competent Authorities and partners. Fast, Easy and Flexible New regulatory reporting requirements, communications with business partners and evolving requirements in adjacent industries like medical devices, nutritional supplements and cosmetics can pose significant challenges to product safety and surveillance operations. To address these challenges, PV-Reporter provides an easy way to create customized reports in any language. Report templates can be saved for repeated use drastically cutting report preparation time and leaving more time for higher value activities such as medical case review and analysis. PV-Reporter also includes powerful querying capabilities which allows business teams to monitor case handling, track compliance, and execute in-depth trend analysis. Advanced data field linking supports context linked queries (i.e. where a given parameter is considered in combination with a specific search record, e.g. product and product misuse). Enhanced grid presentation outputs with multi-row options for multi-record data (such as products and signs) takes interpreting data to the next level. PV-Reporter enables users to save and share query and report layouts for enhanced team efficiency. Core Capabilities Elegant, easy-to-use interface Advanced query tool allowing the creation of complex custom queries with additional search operators and logic Full support for search wildcards and removal of case sensitivity constraints Advanced data field linking to support context linked queries Enhanced grid presentation outputs – with multi-row options for multi-record data Ability to save and share layouts Ability to export parameters and layout definitions Standard regulatory extractions – such as PSUR Key Features Dramatically speeds up report generation Modern and intuitive layout Reduced training overhead to accelerate on-boarding Seamless connectivity to PV-Works or PV247 100% web-based 21 CFR Part 11 compliant Pure Drug Safety (PDS) Case Study “We were happy with the support and respect that Ennov provided which we felt was rare in a SaaS business model.” Phil TURNER, Business Developement Manager Download Now CASE STUDY PV-Reporter – Part of the Ennov Pharmacovigilance Suite PV-Works Learn more PV-Works Vet Learn more PV-Analyzer Learn more PV-Signal Manager Learn more PV-Entry Learn more PV-Reporter Learn more PV-Express Learn more Why Choose Ennov ? Hundreds of corporate customers trust Ennov Over 19 Years of experience providing PV solutions 150+ life science customers, many more in other industries. Modern architecture and interface 100% web-based. Highly scalable. User-centric design Our commitment to your success Very high customer satisfaction, 98.5% of projects delivered on time and within budget. Providing you freedom of choice Available as cloud-based or on-premises deployment You can switch between deployment options at any time. We make you autonomous System configuration and management require no IT skills Improved security and optimized performance Data is hosted locally for total flexibility. Single-tenancy minimizes business interruptions. Cloud-based or On Premises Multi-Platform ISO 9001:2015 certified Stop wasting your valuable Pharmacovigilance resources on repetitive and low-value activities Do not miss our tour of our innovative solution ! Learn more To book a demo, please fill out the form. 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