In Pursuit of the Paperless Clinical Trial: A look at EDC and CTMS (Strategy Focus) : Market Research Report

In Pursuit of the Paperless Clinical Trial: A look at EDC and CTMS (Strategy Focus)

Published by: Datamonitor

Published: Jul. 2, 2008 - 52 Pages

Overview: Catalyst; Summary; Key Messages; Industry pressures to cut costs have companies turning to technology solutions; Regulatory requirements and standards pave the road for eClinical technologies; eClinical solutions enable adaptive trials; Having seen no significant efficiencies from early clinical systems, companies are skeptical; In a segmented eClinical market, partnerships are essential; Interoperability is the key to the future; Table of Contents; Table of figures; Market Opportunity; Industry pressures to cut costs have companies turning to technology solutions; What are eClinical solutions and why should pharma care?; EDC systems are required to increase efficiencies within paper-based clinical trials; Electronic data capture provides higher quality data; Reduction in database lockdown time is a true measurement of EDC success; EDC offers many advantages over the traditional data capture process; The growing complexity of clinical trials calls for a robust CTMS; The benefits of CTMS are endless; Globalization adds fuel to the fire; Regulatory requirements and standards pave the road for eClinical technologies; CDISC ODM defines standards for interchange of clinical trials data; New CDISC initiatives support clinical systems interoperability; Having seen no significant efficiencies from early clinical systems, companies are skeptical; EDC and CTMS adoption have been hindered by pharma's aversion to change; Misconceptions about eClinical technologies slows down implementation; Until recently, there has been a lack of need for full-featured, commercial CTMS solutions; Customer Impact: Clinical solutions increase efficiency and reduce cost; eClinical solutions enable adaptive trials; Adaptive trials result in lower development costs, reduced time-to-market and better patient safety; EDC provides real-time access to patient data; The continuous change involved with adaptive trials requires a robust CTMS; A paradigm shift must take place before eClinical adoption takes-off; Clinical trials solutions must provide an intuitive interface; Life science companies must be educated about the process change involved; Companies will require various hosting models to meet their needs; Current trends in clinical trials will lead to the increase in adoption of eClinical solutions; Cost reduction is a major factor in adopting eClinical solutions; The globalization of clinical trials leads to the need for enhanced management tools; Competitive Landscape; EDC solutions will no longer be a thing of the future; EDC solutions will soon be a commodity rather than a niche technology; As researchers become familiar with EDC, technology transfer models will become more commonplace; Standards and CRF libraries will ease the study building process; CTMS: a stand-alone solution or a value-added function of EDC systems?; CTMS solutions will be viewed as a combination of ERP and CRM technologies; Vendor Market; EDC; Akaza Research; Medidata; Nextrials; OmniComm; Phase Forward; CTMS; Atlantic Research Group; Perceptive Informatics / PAREXEL International; Winchester Business Systems; eClinical SuiteEDC and CTMS; ClinPhone; Oracle; The future of eClinical solutions is interoperability; Signal detection and safety systems will become an essential aspect of an eClinical solution; How will electronic health records integrate with eClinical solutions?; Go to market; Vendors must show how eClinical solutions will streamline the clinical process; Provide solutions to make Phase I EDC trials cost-effective; In a segmented eClinical market, partnerships are essential; Look to integrate essential technologies to reduce redundancy and increase efficiencies; Interoperability is the key to the future; EDC vendors must provide sufficient training for technology transfer; The evolution of clinical data standards will require companies to stay updated; Ensure that IT solutions meet government standards for electronic records; As clinical trials move to global locations, so should vendors
APPENDIX: Definitions and Abbreviations; Methodology; Further reading; Ask the analyst; Datamonitor consulting; Disclaimer
List of Figures: Figure 1: Challenges facing the pharmaceutical industry; Figure 2: Drug discovery and development process; Figure 3: Comparison of paper-based and EDC-based clinical trial process; Figure 4: Advantages of EDC over the traditional, paper-based clinical research process; Figure 5: Obstacles in adoption of eClinical solutions; Figure 6: Percent of R&D IT budget allocated to eClinical solutions in 2007; Figure 7: Adoption level of EDC in 2007; Figure 8: Summary of criteria to consider when choosing an EDC system; Figure 9: Most important criteria for choosing an EDC vendor; Figure 10: Summary of strengths and weaknesses of leading EDC vendors; Figure 11: Summary of key features that a CTMS should incorporate; Figure 12: Summary of strengths and weaknesses of leading CTMS vendors; Figure 13: Summary of strengths and weaknesses of leading eClinical suite vendors

Abstract

Introduction

The cost of developing a drug is reaching astronomical levels, and the life science industry is looking to cut costs wherever possible. Therefore, company executives are turning their attention to improving inefficiencies during the most expensive phase of drug development clinical trials. This report will analyze software solutions developed to streamline the clinical research process.

Scope

Identifies the key forces driving the adoption of eClinical technology solutions
Analyzes the crucial issues that will impede the uptake of clinical research tools
Discusses the key functionalities needed for a complete eClinical solution
Offers insight into how IT vendors can improve their products and evaluates key vendors in the market

Highlights

With costs skyrocketing, companies are turning to computerized systems and IT solutions to increase productivity and maximize the efficiency of clinical trials. The adoption of EDC and CTMS solutions will be integral in enhancing and transforming the data collection and management aspects of a trial.

To fully leverage the benefits of these technologies, eClinical solutions must be built on an interoperable framework that will enable life science companies to run clinical trials in a more efficient manner since many redundancies which currently exist in the point solutions will be eliminated.

Until all stakeholders in the clinical trial process are educated on the true features and benefits of modern clinical technologies and are willing to make the necessary mental and cultural switch, adoption of eClinical solutions will remain sluggish. Vendors should take this opportunity to partner with companies to enhance the research process.

Reasons to Purchase

Validate your market messaging and positioning in the life science industry
Identify strategies that will increase adoption of eClinical technologies
Understand the technology trends that are shaping the future of clinical trials

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In Pursuit of the Paperless Clinical Trial: A look at EDC and CTMS (Strategy Focus)

Table of Contents

Abstract