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  • Krystelis Services Flyer

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    Roopali Aggarwal
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    Krystelis provides clinical trial transparency and writing services to help customers improve patient lives. Their services include clinical trial registry, plain language summaries, redaction and anonymization to comply with regulations, quality review of documents, and consulting. They aim to help customers through recognized quality, value and collaboration.

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    Krystelis provides clinical trial transparency and writing services to help customers improve patient lives. Their services include clinical trial registry, plain language summaries, redaction and anonymization to comply with regulations, quality review of documents, and consulting. They aim to help customers through recognized quality, value and collaboration.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    7 views2 pages

    Krystelis Services Flyer

    Uploaded by

    Roopali Aggarwal
    Krystelis provides clinical trial transparency and writing services to help customers improve patient lives. Their services include clinical trial registry, plain language summaries, redaction and anonymization to comply with regulations, quality review of documents, and consulting. They aim to help customers through recognized quality, value and collaboration.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
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    of 2

    Making

    clinical
    research
    crystal clear

    Our Mission
    To help customers improve the lives of patients by providing services
    recognised for quality, value, and collaboration

    What we offer
    Clinical Trial Transparency

    Writing Services

    Plain Language Services

    Redaction and Anonymisation

    Quality Review

    Administrative Services

    Consulting

    Contact us: info@krystelis.com www.krystelis.com


    Pooja Phogat Stuart Donald
    Co-founder & Co-CEO Co-founder & Co-CEO
    +91-9810 889208 +44-7806 565974
    Clinical Trial Transparency Writing Services
    International and national clinical Regulatory documents (e.g. clinical
    trial registry services (e.g. study reports)
    ClinicalTrials.gov, EudraCT, EU CTR) Marketing authorisation application
    Transparency compliance submission packages
    monitoring Publications (e.g., manuscripts and
    Redaction & anonymisation posters)
    Plain language summaries Writing for HCPs and Patients
    Transparency regulatory consulting Safety writing (e.g. PBRERs & DSURs)

    Plain Language Services Redaction and Anonymisation


    Plain language writing (e.g. informed
    Services for:
    consent, education material,
    EMA Policy 0070, EMA Policy 0043,
    protocol & results summary)
    HC PRCI, Japan PMDA, BfARM,
    Graphic design (e.g. infographic &
    Freedom of Information Act
    video formats)
    EU-CTR 536/2014
    Patient or public panel review
    Voluntary data sharing
    Advisory services (e.g. process
    designing & training) Protocol and SAP redaction for
    Translation and dissemination ClinicalTrials.gov

    Quality Review Administrative Services


    100% verification against source Systems data entry & administration
    Validation using literature (e.g. CTMS, LMS, CTIS)
    references Mailbox monitoring, triaging, &
    Data integrity & internal consistency workflow management (e.g. e-request
    check management, query handling)
    Style, grammar, & formatting check User acceptance testing
    Compliance with templates QA support (e.g. CAPA management,
    Editorial Review SOP writing, complaint management
    Proofreading , editing & peer reviewing Other administrative support services

    Consulting Services Project Management


    Assessing the impact of regulatory Our project delivery is based on
    changes collaboration, consistency, clarity, &
    Advice on how to adapt business continuous learning
    processes most efficiently
    Robust yet flexible PM framework
    Process design including writing
    Strong customer focus
    SOPs
    Enabled by technology allowing
    Implementation plans & change
    automated workflows & real-time
    management, including training
    status reporting

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