Studiebog
    Re-Engineering Clinical Trials

    Re-Engineering Clinical Trials

    - Best Practices for Streamlining the Development Process

    Forfatter: info mangler
    Bog
    • Format
    • Bog, hardback
    • Engelsk

    Beskrivelse

    The pharmaceutical industry is currently operating under a business model that is not sustainable for the future. Given the high costs associated with drug development, there is a vital need to reform this process in order to provide safe and effective drugs while still securing a profit. Re-Engineering Clinical Trials evaluates the trends and challenges associated with the current drug development process and presents solutions that integrate the use of modern communication technologies, innovations and novel enrichment designs. This book focuses on the need to simplify drug development and offers you well-established methodologies and best practices based on real-world experiences from expert authors across industry and academia. Written for all those involved in clinical research, development and clinical trial design, this book provides a unique and valuable resource for streamlining the process, containing costs and increasing drug safety and effectiveness.

    Læs hele beskrivelsen
    Detaljer
    • SprogEngelsk
    • Sidetal360
    • Udgivelsesdato19-12-2014
    • ISBN139780124202467
    • Forlag Academic Press Inc
    • FormatHardback
    Størrelse og vægt
  • Vægt750 g
    • coffee cup img
    10 cm
    book img
    15,1 cm
    22,9 cm

    Findes i disse kategorier...

    Se andre, der handler om...

    Internet Innovation Evolution Performance Mobility Cancer Training Research Clinical trials Data mining Knowledge Knowledge management Multiple Sclerosis Organization Organizational learning Recruitment Risk Risk management Standards Lean management Standardization Collaboration Value added Safety Prognosis Mechanism of action Magnetic resonance imaging Quality Tools Statistics Cost-effectiveness Scientific literature Blood pressure Ecosystem OPTIMIZATION Smartphones Social media Waste Data management Clinical trial Failure mode and effects analysis Big data cro people Metrics SOP Innovative Medicines Initiative Flexibility Impact analysis Metric Knowledge transfer Public-Private-Partnership Re-engineering Interoperability Enrollment Subject Process Improvement Threshold Processes Biomarkers ISF TMF Clinical research Adaptive design Accelerometer Technologies Message Learning and development EHealth Lean development Patient Reported Outcomes Set-Based Engineering Solution Protocol design Agile development Study design Expanded Disability Status Scale MCC Stakeholder involvement Milestone Pharma SWOT Adaptive Learning Regulatory Regulatory framework Regional differences Risk-based Monitoring Change-Management Data quality Drug Development Process Efficacy Competencies Real Time Data Finding Traditional media MHealth Disease course Community outreach EDC Ethics committee CDISC Single-Source-of-Truth Orphan diseases Acceleromics biomarker qualification Central monitoring Central rating Clinical study protocol Clinical research associate (CRA) Case record form (CRF) Critical data Data reuse data tracking clinical data management Drug success rates Drug approvals Data transparency Business incentives Enrollment capacity Coordinating center CIOMS Ecologic validity Data optimization electronic informed consent Clinical data analyst (CDA) Drug development economics Extraneous clinical data Clinical research and clinical investigators Competency Profile Continuous Improvement Culture Extraneous end points Glucose meter Data standards Data Visuals health system inter-rater reliability Double-blind studies Drug development cycle times Drug development process inefficiencies Drug failure rates Investigator site file Electronic data capture (EDC) Multinational trial Patient pathway Placebo group Prediction of treatment activity Productivity Gap Global pharmaceutical consumption Protocol feasibility Process- Operationally seamless Referral network Regulatory framework of clinical trials Regulatory submissions Population enrichment Information supply chain management Protocol checklist Protocol complexity Inferentially seamless Recognition and certification Risk-benefit Prognostic matching Quality and risk management Source document verification (SDV) Site performance Sustained progression risk indicator Shop Floor Management Virtual patient group virtual visits Trial Master file Mobile accelerometry Stratified medicine web-based patient selection Oracle Life Science Hub (LSH) Patent cliff Surrogate markers virtual randomized controlled trials Seamless phase II/III Productivity challenges Trial execution Validation of surrogate markers Recruitment tactics systems- and training-optimization

    Velkommen til Saxo – din danske boghandel

    Hos os kan du handle som gæst, Saxo-bruger eller Saxo-medlem – du bestemmer selv. Skulle du få brug for hjælp, sidder vores kundeservice-team klar ved både telefonerne og tasterne.

    Om medlemspriser hos Saxo

    For at købe bøger til medlemspris skal du være medlem af Saxo Premium, Saxo Shopping eller Saxo Ung. De første 7 dage er gratis for nye medlemmer. Medlemskabet fornyes automatisk og kan altid opsiges. Læs mere om fordelene ved vores forskellige medlemskaber her.

    Machine Name: SAXO080