TwitterLinkedin

Contact Us

  • News & Events
    • News
    • Webinars
    • Events
  • Resource Library
    • Thought Leadership
    • Fact Flyers
    • Case Studies
    • White Papers
    • Webinars
    • Infographics
    • Video & Animation
  • Careers
    • Working at PharmaLex
    • Your Application Process
    • Current Opportunities
  • Training
Top Bar
Search
PharmaLex Logo
MENUMENU
  • PharmaLex Logo
  • PharmaLex Logo
  • About UsAbout Us
    • About Us
    • Management Team
    • Our Milestones
    • Corporate Social Responsibility
    • What Our Clients Say About Us
  • Our Services
    • Discovery / Non-clinical
          • Go to Discovery / Non-clinical section >>

          • Strategy and Consulting

            • Development Strategy and Gap Analysis
            • Integrated Product Development
            • Market Access
            • Non-clinical Development Concept
              and Study Design
            • Scientific Advice
            • Scientific Due Diligence
            • Statistical Services
            • Toxicology Services
    • Clinical Development
          • Go to Clinical Development section >>

          • Strategy and Consulting

            • Clinical Program Development
            • Orphan Drug Designation
            • Pediatric Investigation Plan (PIP)
            • Scientific Advice
            • Statistical Services
          • Regulatory Affairs

            • Clinical Trial Applications
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Regulatory Operations
          • Pharmacovigilance

            • Clinical Trial Safety Support
            • Pharmacovigilance Consulting
          • Quality

            • GxP Services
            • IMP Management
            • Interim / Contract QA
            • Quality Management Systems
            • Tech Transfer / Scale-up
            • Vendor Management and Oversight
    • Authorization / Approval
          • Go to Authorization / Approval section >>

          • Strategy and Consulting

            • Market Access
          • Regulatory Affairs

            • CMC Services
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Marketing and Labeling Activities
            • Regulatory Operations
            • Scientific, Regulatory and Technical Writing
            • Statistical Services
          • Pharmacovigilance

            • EU QPPV / National QPPV
            • Pharmacovigilance Consulting
          • Quality

            • Commercialization Readiness
            • Commissioning, Qualification, and Validation (CQV)
            • GxP Services
            • Interim / Contract QA
            • PAI Readiness
    • Post-approval / Maintenance
          • Go to Post-approval / Maintenance section >>

          • Strategy and Consulting

            • Environmental Risk Assessment
            • Market Access
          • Regulatory Affairs

            • CMC Services
            • Global End-to-End Outsourcing
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Marketing and Labeling Activities
            • Mergers and Acquisitions (M&A) Transfers
            • Regulatory Operations
            • Toxicology Services
          • Pharmacovigilance

            • Audit and CAPA Management
            • EU QPPV / National QPPV
            • ICSR Management
            • Literature Screening
            • Pharmacovigilance Systems
            • Safety Writing (PSUR, RMP)
            • Signal Management
          • Quality

            • Commissioning, Qualification, and Validation (CQV)
            • Good Distribution Practice (GDP) Compliance
            • GxP Services
            • Interim / Contract QA
            • Quality Management Systems
            • Vendor Audit
            • Vendor Management and Oversight
          • Medical Affairs

            • Healthcare Compliance and Medical Approval
            • Medical Information
    • Program Management
          • Go to Program Management section >>

          • Program Management

            • Global End-to-End Outsourcing
            • Global Procedure Management
            • Integrated Product Development
            • Mergers and Acquisitions (M&A) Transfers
    • Featured Expertise
          • Industry Expertise

            • Biopharmaceuticals
            • Consulting
            • Consumer Healthcare
            • Generics
            • Herbal Medicines
            • Medicinal Products
            • MedTech Services
            • Pharmaceutical
            • Veterinary Drugs
          • Service Expertise

            • ATMP / Cell and Gene Therapy
            • Brexit
            • COVID-19 Support
            • Drug Re-purposing / Value-added Medicines
            • GxP Services
            • Market Access
            • Pharmacovigilance Consulting
            • Statistical Services
            • SMARTPHLEX - technology-enabled services
  • Global ReachGlobal Reach
  • Contact usContact us
  • News & Events
    • News
    • Webinars
    • Events
  • Resource Library
    • Thought Leadership
    • Fact Flyers
    • Case Studies
    • White Papers
    • Webinars
    • Infographics
    • Video & Animation
  • Careers
    • Working at PharmaLex
    • Your Application Process
    • Career Opportunities
  • Training
Home > SMARTPHLEX > SMARTVIGILIT

SMARTVIGILIT

Smart literature surveillance

SMARTVIGILIT® system is a quality-assured environment that supports all functions related to your legal obligations for literature surveillance. The service has been successfully inspected by MHRA and BfArM. It independently performs weekly database searches within PubMed. It is a web-based solution that can be accessed by any browser / operating system worldwide. You can assign as many users as needed.

After setting up searches in consultation with the client in the SMARTVIGILIT system, we continuously monitor the safety literature for the relevant product. A team of well-trained and experienced staff will be responsible for the references rating within the system. Alerts on potential cases will be identified and made available to you via an automatic push mail. Process detected case reports can also be automatically pushed to you in a CIOMS I or E2B-compatible format, if needed. A duplicate check is performed for all your case reports against cases provided by the monitoring of medical literature service from EMA (MLM). Other safety literature relevant for your products can be queried by category, product name and time interval without additional fees to perform e.g. signaling or create PSURs. SMARTVIGILIT can be integrated in your current pharmacovigilance system.

Features

  • Global coverage for all substances
  • No user limitations
  • Comprehensive, e-enabled, easy to access platform
  • Validated solution in line with GAMP 5, compliant with US Title 21 CFR part 11
  • Web-based tool, no install / update required for customers, easily scalable
  • Fully integrated in PV services (end-to-end processing)
  • Classification of ICSRs, PSUR relevant, efficacy information
  • Profound expertise paired with consulting activities
  • Automatic import of literature references from various databases (e.g. PubMed)
  • Triage and assessment of references
  • SafeGuard AI to identify potentially overseen ICSRs
  • User frontend, generation of reports
  • Automated push-mail to client with identified references for different categories

Benefits

  • End-to-end solution: integrated part of our service landscape, our tool covers the steps of PV literature screening from import, assessment to full case processing in standard formats (e.g. E2B XML, CIOMS, MedWatch)
  • Improved compliance: service successfully audited / inspected (MHRA recommendation); quality level (GAMP-5); Title 21 CFR Part 11/Annex 11 compliant
  • Gain efficiency: detection of duplicates from and streamlined processing of safety relevant literature references for ICSRs, periodic reports, efficacy evaluation

To find out more or request a demonstration

CONTACT US

Related News

Hospital_Exemption-ATMPs
Hospital Exemption for ATMPs Webinar
15th October 2020
medical device combination products brexit
BREXIT: Medical Device/Combination Products - Key changes
3rd September 2020
pharmacovigilance brexit
BREXIT: Pharmacovigilance - Key changes
3rd September 2020

Related Resources

Fact Flyers

  • SMARTVIGISCREEN
  • SMARTVIGICONTRACT
  • Pharmacovigilance Services postcard

Case Studies

  • Full service post-marketing and clinical trial PV activities for mid-sized pharma company
  • Full service Post-Marketing Pharmacovigilance and Medical Information Services for large nutritional health company
  • Dendritic cell vaccine (oncology)
  • Strategic outsourcing of mature product portfolio
  • Post–M&A PharmaLex program governance
  • Post–M&A pharma infrastructure development
  • Full PV service outsourcing

Webinars

  • Eudravigilance: overcoming challenges and gaining efficiencies with SMARTVIGISCREEN
  • EudraVigilance – The fundamental tool for Pharmacovigilance

Related Services

  • Clinical Trial Safety Support
  • EU QPPV / National QPPV
  • ICSR Management
  • Literature Screening
  • Medical Information
  • Pharmacoepidemiology
  • Pharmacovigilance Consulting
  • Pharmacovigilance Systems
  • Risk Management Support
  • SMARTPHLEX
  • SMARTVIGICONTRACT
  • SMARTVIGISCREEN
USEFUL LINKS
  • Home
  • Contact us
  • Imprint
  • Data Protection
  • Terms and Conditions
RECENT TWEETS
Tweets by @PharmaLexGLOBAL
COVID-19 NEWSLETTER SIGN UP

SIGN UP NOW

WHAT OUR CLIENTS SAY
  • Able to explain technical details so non-experts can understand

    US based small / virtual company
    Partner
PharmaLex
©2021 PharmaLex GmbH. All rights reserved.

ISO9001:2015 LogoEnergie Audit Logo

#AskTheExpert #TogetherBEYONDCOVID19





    Select your state:

    .
    You can unsubscribe at any time at data.protection@pharmalex.com

    If you do not wish to receive any communication from us, you can unsubscribe at any time at. Click here to view our Privacy Policy.

    #TogetherBEYONDCOVID19

    We closely monitor developments and updates surrounding the current outbreak of Coronavirus Disease 2019 (COVID-19) from official sources including the World Health Organisation and are following the guidance and direction of the governments and the local authorities. We are taking this situation very seriously and our number one priority is the safety and business continuity for our customers and colleagues. As ever, we will do everything we can to ensure that services are delivered within the required time and the trusted quality PharmaLex is known for

      Please DO NOT send us event/conference information.
      We will not respond and these will be deleted immediately.





      Select your state:

      .
      You can unsubscribe at any time at
      data.protection@pharmalex.com

      If you do not wish to receive any communication from us, you can unsubscribe at any time at. Click here to view our Privacy Policy.

      Privacy Policy

      This can be specific information about signing up to the newsletter.

      Pellentesque lobortis, tellus at ultrices ullamcorper, lectus tellus consectetur lectus, id consequat leo quam quis eros. Mauris pellentesque tortor a augue pellentesque ultricies. Phasellus sit amet suscipit orci, vel dapibus ligula. Maecenas at pellentesque lectus, sit amet tristique felis. Integer fringilla risus ac neque mollis, at imperdiet lacus sodales. In vehicula orci sed vulputate interdum. Nunc sagittis non nunc eget sollicitudin.

      Maecenas a mattis erat. Phasellus cursus erat non nisl pulvinar ultricies. Aenean id fringilla libero. Orci varius natoque penatibus et magnis dis parturient montes, nascetur ridiculus mus. Morbi in ultrices elit. Suspendisse egestas hendrerit est. Integer pellentesque nisl ut justo tempus, nec suscipit dolor luctus. Cras vestibulum elementum tincidunt.

      In compliance with the Spanish Law 15/1999, of Protection of Personal Data and in accordance with regulations approved by the Spanish RD 994/1999 inform you that your data will be part of a file located in Friedrichsdorf (Germany), whose ownership belongs to Pharmalex Spain S.L.U. The purpose of these data is the insertion in a potential job selection process. Inform the user that at any time may exercise their right of access, rectification, and deletion of data through email curriculum@pharmalex.com or to this postal address Pharmalex Spain. Coso 103, 50001 Zaragoza, Spain.