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Growth Opportunities in Clinical Trial Data Management and eClinical Solutions Market, Forecast to 2020

  • ID: 4462523
  • Report
  • Region: Global
  • 87 Pages
  • Frost & Sullivan
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Digitization Presents Opportunities for Unified Cloud-based Platform Solutions to Optimize Clinical Trial Workflows


  • 4G Clinical
  • CliniOps
  • Medidata
  • Oracle
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The global clinical trial IT market is expected to grow from $2.63 billion in 2016 to $4.29 billion in 2020 at a compound annual growth rate (CAGR) of more than 13.0%. North America will continue to hold the largest market share (by revenue) in 2017, followed by Europe. Increasing clinical trial activities in the emerging Asia-Pacific markets and recent favorable regulatory reforms (China to accept overseas trial data; Indian government allowing?  academic institutions to take Drug Controller General of India (DCGI) permission) are expected to drive the demand for clinical trial IT solutions from 2017 to 2020. Clinical trial data management (CTDM) and emerging eClinical solutions comprising electronic data capture (EDC), clinical data management systems (CDMS), clinical trial management systems (CTMS), randomization and trial supply management systems (RTMS), electronic clinical outcome assessment (eCOA), trail planning and safety solutions, clinical data integration platforms, and clinical analytics platform have the largest market shares in the total clinical trial IT solutions, and are estimated to touch $4,051.6 million in 2020.

Digital transformation is leading the clinical trial industry towards a data centric approach. The increasing volume and veracity of data that can be leveraged beyond traditional clinical data sets requires clinical trial IT systems to shift from fragmented application-centric IT systems to unified data-centric solutions. Furthermore, the rising demand for quality data and novel endpoints demands CTDM solutions to migrate from point solutions that sit in silos to integrated eClinical solutions that provide a single source of truth, optimize costs by eliminating duplicate data entry, and reduce on-site verification and source data verification rate (SDVR). This involves an evolving vendor ecosystem of modular, cloud-based eClinical solutions with intuitive user interface that is capable of integrating all possible study and eSource data to enhance clinical trial digital workflows and reduce data management cost and time.

Research Scope

The research service analyzes the top four growth opportunities in the global CTDM and emerging eClinical solutions. It also evaluates and discusses market projections, key trends, technology life cycle (adoption rate vs maturity), key implementation benefits, and challenges of top four CTDM and emerging eClinical solutions. Finally, it provides industry best practices, live case studies, cost benefit analysis, and strategic imperatives (call to action) for key clinical trial industry stakeholders such as pharma sponsors, CRO, sites, and technology providers.

Key Issues Addressed

  • What are the key trends and growth opportunities that can be derived from the emerging digitally-led clinical trials operating models?
  • Which technologies and IT systems (EDC, eSource, eCOA, RTSM) will have the strongest potential to optimize clinical workflows?
  • What is the technology lifecycle for select clinical trials IT solutions (current adoption and future growth rates)?
  • What are the gaps and inefficiencies in current CTDM workflows and how can these be filled by emerging clinical IT solutions?
  • What does the new ecosystem of unified clinical IT systems/ eClinial solution providers look like?
  • What are the key challenges while implementing these digital solutions across the clinical development value chain?
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  • 4G Clinical
  • CliniOps
  • Medidata
  • Oracle
  • MORE

1. Executive Summary

  • Six Big Themes Driving Clinical Trial Digitization
  • Scope and Segmentation-Clinical Trial Data Management and eClinical Solutions Market
  • Key Questions This Study Will Answer
  • Top 4 Growth Opportunities-CTDM and eClinical Solutions
  • Implementation Challenges for Select CTDM and eClinical Solutions
  • CDTM and eClinical Solutions Market-Regional Market Size and Growth Potential

2. Market Definition and Overview

  • Market Definition-CTDM and eClinical Solutions Market
  • Clinical Trial IT Market-Major Application Segments and Technologies
  • Vendor Ecosystem-Clinical Trials IT Solutions Market

3. Macro and Micro Scenario Analysis

  • Evolving Clinical Trial Business Model Transformation
  • Six Big Themes Driving Clinical Trial Digitization
  • Continuing Clinical Trial Challenges
  • Evolving Clinical Trials Models for Precision Oncology Therapeutics
  • Focus on Patient-centricity-Case Examples
  • Evolving Clinical Trial Models
  • Clinical Trial Enrichment
  • Entry of Non-traditional Players
  • Digital Continuity

4. Market Overview and Forecast-Clinical Trial Data Management and eClinical Solutions

  • Market Projection for CTDM and eClinical Solutions Market
  • Technology Lifecycle for Select Clinical Trial IT Solutions
  • Forecast for CTDM and eClinical Solutions

5. eCOA/ePRO Growth Opportunities

  • Category Definition-eCOA Technologies
  • Evolving eCOA Solutions Modalities for Trials-From COD to BYOD
  • Key Performance Indicator for eCOA Solutions by Modality Types
  • Growth Opportunity 1-eCOA Technologies
  • eCOA Systems Market Forecast
  • Forecast for eCOA Systems
  • Forecast-Key Trends for eCOA/ePRO Solutions
  • eCOA Adoption Trend by Device Modality Types
  • ROI Scenario Analysis-Cost Comparison of Paper vs eCOA
  • Scenario Analysis-Cost Comparison of Paper versus Multi-modality eCOA
  • Case Study-eCOA Implementation Benefits for Top 10 Pharmas

6. EDC Solutions Growth Opportunities

  • Evolving Clinical Trials Data Capture and Management Systems
  • EDC System Integration Scope with Traditional Clinical IT Systems and Emerging eSource Data Capture Solutions
  • Current Challenges and Role of eSource + EDC Technologies
  • Growth Opportunity 2-Electronic Data Capture (EDC)
  • EDC/CDMS Systems Market Forecast
  • Forecast for EDC Systems
  • Forecast-Key Trends for EDC/CDMS Systems
  • Case Study-Integrated eSource and EDC Solution
  • Case Study-eSource Data Monitoring ROI Analysis by Major Value Chain Activities

7. Clinical Informatics and Cloud Storage Solutions

  • Category Definition-Life Sciences Analytics Solutions Types
  • Growth Opportunity 4-Clinical Informatics and Cloud Storage
  • Clinical Development Informatics Market Overview
  • Analytics Application Scope by Key Clinical Development Activities
  • Case Study-Advanced Clinical Informatics Visualization to Optimize Clinical Trial Safety Study and Adverse Event (AE) Reporting
  • Clinical Development Cloud Market Overview

8. RTSM/IRT Systems Growth Opportunities

  • Evolution of RTSM Technology and Terminology
  • Growth Opportunity 5-RTSM/IRT Systems
  • RTSM/IRT Systems Market Forecast
  • Forecast for RTSM/IRT Systems
  • Case Study-RTSM Systems Benefits for Sponsors

9. Key Conclusions and Strategic Imperatives

  • CDTM and eClinical Solutions-Strategic Imperatives for Key Industry Stakeholders
  • eClinical Solutions Convergence Potential with Emerging Technologies
  • Clinical Trials IoT Ecosystem-2025
  • 5 Competitive Factors Key to the Success of Clinical Development IT Solutions
  • Legal Disclaimer

10. Appendix

  • List of Exhibits
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  • 4G Clinical
  • CliniOps
  • Medidata
  • Oracle
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