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INTIENT Pharmacovigilance


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A product suite that collects, manages and learns from the full spectrum of pharmacovigilance data. Visit to learn more.

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INTIENT Pharmacovigilance

  1. 1. INTIENT Accenture Life Sciences PHARMACOVIGILANCE TM Provides Earlier Insights, Better Data Transparency, Improved Accuracy and Consistency
  2. 2. PHARMACOVIGILANCE IMPERATIVES FOR THE PHARMA INDUSTRY EFFECTIVE & EFFICIENT OPERATIONS INCREASED FOCUS: SAFETY, SCIENCE & INSIGHT INCREASED VALUE FOR KEY STAKEHOLDERS Copyright 2020 Accenture. All rights reserved. 2 • Highly efficient quality case processing • Better Patient Support Programs • More informed HA interactions, better “brand” for Safety and Patients • Better evaluation of detected signals • External signals validation (get a better view of benefit-risk) • New data sources, tools and technologies • Innovative ways of visualizing data and gleaning insights using AI/ ML • More informed product and program design • More informed labels and PV Regulatory Coordination • Networked with healthcare practitioners • Supporting safety literacy across the ecosystem
  3. 3. INTIENT Pharmacovigilance helps life sciences companies accelerate processes and the generation of critical insights—insights that can help companies uncover patient safety impacts from existing products and better manage the risks of new products, as well as respond to new stakeholder demands across the healthcare landscape. INTIENT Pharmacovigilance Copyright 2020 Accenture. All rights reserved. 3
  4. 4. INTIENT Pharmacovigilance Copyright 2020 Accenture. All rights reserved. 4 • Delivers a centralized environment to collect, manage and learn from the entire spectrum of patient safety data • Embeds real-time artificial intelligence, machine learning, robotic process automation and advanced operational and scientific analytics in each step of the pharmacovigilance process—from patient data source and case intake to regulatory reporting and distribution • Provides earlier insights, better data transparency, improved accuracy and consistency in reporting, and more timely discovery of potential adverse events
  5. 5. DISRUPTING THE NORMAL PROCESS FOR CASE INTAKE & PROCESSING … THE OLD MANUAL WAY CASE INTAKE/ DATA ENTRY ROUTE TO CASE PROCESS- ING CASE PROCESS- ING ROUTE TO QUALITY REVIEW Copyright 2020 Accenture. All rights reserved. 5 Email, Fax, Paper, Batch Duplicate check Identify seriousness Prioritize case (Day0) Split cases (multiple patients) Link cases Complete the data entry of all case details Use of IME and Drug lists Medical history Generate narrative and modify Identify missing and incorrect info Request follow up
  6. 6. • Automated Case Intake • Case Processing • Using AI, ML, NLP, OCR XML export to Safety System for case completion • Exception Handling UI • Review corrections and acceptance ML FEEDBACK LOOP …BYRADICALLY AUTOMATINGTO MAKEITPARALLEL, ACCURATE, CONSISTENT, FOCUSEDAND HIGHLYEFFICIENT. THE NEW WAY Copyright 2020 Accenture. All rights reserved. 6
  7. 7. Powered by Applied Intelligence, incorporates artificial intelligence, robotic process automation, natural language processing, optical character recognition, machine learning and machine translation INTIENT Pharmacovigilance Enables pre-processing of all types of machine-readable source documents to generate well-formed and high quality E2B output for import into an enterprise safety system such as Argus Safety Extracts case data from structured and unstructured sources, and assesses the priority, seriousness, expectedness and causality based on cognitive inference and with a confidence score for each field Delivers proven technology, as the platform is currently on its third GA release and is governed by a validated system development lifecycle, and is therefore ready for implementation now INTEGRATION SERVICES ANALYTICS APPLICATIONS DATA INFRASTRUCTURE Re-invents the role of case handling teams from processing cases to managing exceptions, allowing companies to focus effort, energy and talent on strategic activities to help improve patient safety outcomes Offers advanced safety analytics for deriving improved insights from combined internal and external sources, with greater accuracy and new visualisations to make more better and more timely safety interventions Copyright 2020 Accenture. All rights reserved. 7
  8. 8. APPLIED INTELLIGENCE ACCENTURE + IN PHARMACOVIGILANCE Copyright 2020 Accenture. All rights reserved. 8
  9. 9. INTIENT PV – GENERATION 0 • Text Analytics with Literature • Automating drug safety analysis with Natural Language Processing INTIENTPV– DESIGNPHASE GENERATION1.0 • Modular, Scalable Platform Approach • User Experience Critical for Success • Technology Enabled Operations INTIENT PV – RPA BOTS LIVE • Book In and Email Use Cases • Accenture First in Industry • First in R&D with RPA INTIENT PV V1.0 – MARKET RELEASE • POCs and Pilots with 2 Tier 1 biopharma • Focus on Literature Entity Extraction, NLP, and OCR INTIENT PV V2.2 – PRODUCTION USE AT CLIENT • Integrated with Argus • Unstructured & Structured Forms • Tech Enabled Ops Business Case INTIENT PV – EXPANSION • Convergence with AIHC • Re-use of micro services and analytics / insights 2015 2016 2017 2018 2019 NEXT Copyright 2020 Accenture. All rights reserved. 9
  10. 10. WE SUPPORT THE ENTIRE PHARMACOVIGILANCE JOURNEY From Proof Of Concept to End-to-end Services PROOF OF CONCEPT Demonstrate platform capabilities and provide evidence of efficiency using B-R frameworks and Safety Signal Detection – a subset of cases INDUSTRIALIZE / ADOPT the new methods for B-R and Signal Detection CREATE & EXECUTE A PV ANALYTICS ROADMAP for the remaining use cases’ industrialization and adoption IMPLEMENT PV ANALYTICS ENVIRONMENT capitalizing upon proof- of-concept experience and insight ESTABLISH ONGOING PARTNERSHIP for PV Analytics services START NEXT Copyright 2020 Accenture. All rights reserved. 10
  12. 12. • Argus Global Implementation • Argus J Implementation • Argus Application Maintenance • Argus Implementation on Cloud • Development and maintenance of Custom Safety Reports SYSTEM INTEGRATION & IMPLEMENTATION We have successfully delivered seven major safety database implementation/ upgrade programs in the life sciences industry, with high-quality and timely execution in realizing an advanced safety case processing capability. • Scope and Seek Work • PV IT Roadmap Development • Process Optimization and Change Management • Operating Model Design • PV Analytics Platform • AE EDC and Workflow Solutions PV CONSULTING Copyright 2020 Accenture. All rights reserved. 12
  13. 13. QUESTIONS? APRIL DAVIS Industry Principal Director Life Sciences, Pharmacovigilance Copyright 2020 Accenture. All rights reserved. 13 Learn more: