Is Your Safety Inbox a Black Hole?
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The document presents an overview of November Research Group, a leader in pharmacovigilance solutions, detailing its services, capabilities, and the challenges faced in collecting adverse events in drug safety. It highlights the Primo platform, designed to optimize the intake process of adverse event data, addressing issues like lost emails and data quality. The document emphasizes the importance of compliance and efficiency in managing safety information from diverse sources.
Is Your Safety Inbox a Black Hole?
- 1. Is Your Safety Inbox a Black Hole? July 9, 2015 Presenter: Brad Gallien VP, Product Development November Research Group
- 2. 2NOVEMBER RESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions This document is proprietary to November Research Group. It is supplied in confidence and, except for evaluation purposes, cannot be disclosed, duplicated or otherwise used in whole or in part without the prior written consent of November Research Group. The content of this document is subject to formal contract negotiations. Nothing in this document shall form the basis for any contract and nothing contained in this document will be binding against November Research Group unless expressly agreed to by November Research Group under a formal contract. All representations and warranties whether express or implied by statute, law or otherwise, are hereby excluded. This document was prepared on the instructions and information and accordingly no responsibility is accepted for any inaccuracy or error or any action taken or not taken in reliance on this document. This document makes reference to trademarks that may be owned by others. The use of such trademarks is not an assertion of ownership of such trademarks by November Research Group and is not intended to represent or imply the existence of an association between November Research Group and the lawful owners of such trademarks. Safe Harbor
- 3. Summary A quick look into the presentation NOVEMBER RESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions • About November Research Group • Collection of Adverse Events • Challenges • Business Impact • PRIMO Overview • Demo • Wrap-Up
- 4. 4NOVEMBER RESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions About November Research Group • November Research Group (NRG) provides global drug safety system implementation services and software solutions for pharmaceutical and life science organizations – 70 consultants specializing in Oracle Argus, Oracle AERS, Empirica Trace – Experts in product safety regulations and pharmacovigilance systems – Global projects in the US, Europe and Japan – Dedicated Japanese practice area • What we do? – Argus Safety implementation – Software tools such as PRIMO – AERS support – Complex data migration projects – EQMS, BPM projects – Custom reporting – Business Transformation Who are our partners? Gold Partner Specialized Oracle Argus Safety
- 5. 5NOVEMBER RESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions Our Capabilities Services Software Evaluation & Vendor Management PV Process Optimization Platform Upgrade/ Implementation Migration Training Validation Support Products PRIMO Platform Family PRIMO Manufacturer PRIMO Regulatory PRIMO MR iPRIMO Reporting Tool: WebReports E2B Viewer Incorporating lessons learned from previous projects Strong knowledge of global requirements: U.S., EU & Japan Experts in Argus implementations PMP certified project managers Risk based approach mitigating compliance risk Successful track record for extending the capabilities of commercial-off-the-shelf (COTS) safety systems 20+ years of product development experience in Life Sciences Senior management experience in safety software development Robust system development lifecycle Maintenance includes enhancements & updates English/Japanese speaking senior consultants drive project deliverables & communication transparency Validation best practices compliant with CFR Part 11, EMA and PMDA regulations
- 6. 6 PRIMO Family Matrix Overview Regulatory Market Manufacturer Market PRIMO 3.0 PRIMO 2.1 PRIMO Mobile Audience Global Regulatory bodies such as the US FDA, MHLW, EMA, TGA, etc. PV team Sales/Field Representatives (and PV team) Overview • Intake regulatory submissions from manufacturers and consumers (MedWatch, E2B, etc.) • Quickly and efficiently review inbound data for public health impact • Comprehensive correspondence management • Query and analyze data for trends or other issues • Central Intake system to facilitates the timely acquisition of safety information from all sources such as tweets, faxes and emails • Comprehensive correspondence management for intake and follow-up • Tight integration with Global PV system • Capture full MR data entry footprint (fields) for potential adverse event • PV-MR follow-up correspondence • Send secure email or E2B to PV team Technology • Apache Flex/Oracle • Apache Flex/Oracle • HTML5/MySQL
- 7. 7NOVEMBER RESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions Collection of Adverse Events Adverse events are collected from multiple sources including: • Spontaneous • Literature • Social Media • Partners • Sales representatives • Clinical Trials Typically, adverse events are forwarded to a company’s Safety Group Inbox. This can lead to many challenges posing risks to the safety profile of products.
- 8. 8NOVEMBER RESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions Challenges Lost Emails Data Quality Issues Manual Communication Disconnected workflow Limited Audit Controls
- 9. 9NOVEMBER RESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions How Does This Impact Your Business Process? PV departments struggle with intake and find themselves spinning their wheels to address challenges.
- 10. 10NOVEMBER RESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions PRIMO High-Level Workflow – PRIMO Overlay Sources Intake Review Triage 1 2 3 4 5 ① Emails directly pulled and stored in PRIMO ② Automated letter generation and follow-up tracking ③ Full lifecycle of correspondence tracked ④ Report exchange with external systems ⑤ Fully audited and compliant process All sources of potential AEs Commercials systems such as Oracle Argus, ARISg, Sparta Trackwise or Pilgrim PV/EQ MS
- 11. 11NOVEMBER RESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions PRIMO Benefits Features Benefits Light-weight and easy to use Decrease data entry errors Support all intake streams Instant metrics Management of complete intake lifecycle Improved efficiency with a single intake solution Correspondence Management Decrease follow-up response time PV System integration Process ICSRs faster and boost your customers’ reporting timeliness PRIMO is designed to make your intake process more transparent and more compliant
- 12. 12NOVEMBER RESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions This product demonstration is only available for webinar live attendees. If you’d like to see a demo, please contact us: • Brad Gallien – VP, Product Development brad@novemberresearch.com (415)279-9107 • Seth Warhaftig – President seth@novemberresearch.com (415) 987-3313 Product Demonstration
- 13. 13NOVEMBER RESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions Questions? Please submit your questions using the Q&A feature in the WebEx panel
- 14. 14NOVEMBER RESEARCH GROUP Dedicated Leader in Pharmacovigilance Solutions • Visit our website http://www.novemberresearch.com/ • Download PRIMO Datasheet http://www.novemberresearch.com/files/PRIMODataSheetEnglish.pdf • Brad Gallien – VP, Product Development brad@novemberresearch.com (415)279-9107 • Seth Warhaftig – President seth@novemberresearch.com (415) 987-3313 Next Steps