发布时间：2008.7

摘要

Overview

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

目录及图表

Overview	1
Catalyst	1
Summary	1
Key Messages	2
Industry pressures to cut costs have companies turning to technology solutions	2
Regulatory requirements and standards pave the road for eClinical technologies	2
eClinical solutions enable adaptive trials	3
Having seen no significant efficiencies from early clinical systems, companies are skeptical	3
In a segmented eClinical market, partnerships are essential	3
Interoperability is the key to the future	4
Table of Contents	5
Table of figures	5
Market Opportunity	6
Industry pressures to cut costs have companies turning to technology solutions	6
What are eClinical solutions and why should pharma care?	6
EDC systems are required to increase efficiencies within paper-based clinical trials	8
Electronic data capture provides higher quality data	8
Reduction in database lockdown time is a true measurement of EDC success	9
EDC offers many advantages over the traditional data capture process	10
The growing complexity of clinical trials calls for a robust CTMS	11
The benefits of CTMS are endless	12
Globalization adds fuel to the fire	12
Regulatory requirements and standards pave the road for eClinical technologies	13
CDISC ODM defines standards for interchange of clinical trials data	13
New CDISC initiatives support clinical systems interoperability	13
Having seen no significant efficiencies from early clinical systems, companies are skeptical	14
EDC and CTMS adoption have been hindered by pharma's aversion to change	15
Misconceptions about eClinical technologies slows down implementation	16
Until recently, there has been a lack of need for full-featured, commercial CTMS solutions	16
Customer Impact: Clinical solutions increase efficiency and reduce cost	17
eClinical solutions enable adaptive trials	17
Adaptive trials result in lower development costs, reduced time-to-market and better patient safety	17
EDC provides real-time access to patient data	17
The continuous change involved with adaptive trials requires a robust CTMS	18
A paradigm shift must take place before eClinical adoption takes-off	18
Clinical trials solutions must provide an intuitive interface	19
Life science companies must be educated about the process change involved	19
Companies will require various hosting models to meet their needs	19
Current trends in clinical trials will lead to the increase in adoption of eClinical solutions	20
Cost reduction is a major factor in adopting eClinical solutions	20
The globalization of clinical trials leads to the need for enhanced management tools	20
Competitive Landscape	22
EDC solutions will no longer be a thing of the future	22
EDC solutions will soon be a commodity rather than a niche technology	22
As researchers become familiar with EDC, technology transfer models will become more commonplace	22
Standards and CRF libraries will ease the study building process	23
CTMS: a stand-alone solution or a value-added function of EDC systems?	23
CTMS solutions will be viewed as a combination of ERP and CRM technologies	24
Vendor Market	24
EDC	24
Akaza Research	29
Medidata	30
Nextrials	31
OmniComm	32
Phase Forward	33
CTMS	34
Atlantic Research Group	37
Perceptive Informatics / PAREXEL International	38
Winchester Business Systems	39
eClinical Suite - EDC and CTMS	40
ClinPhone	41
Oracle	42
The future of eClinical solutions is interoperability	44
Signal detection and safety systems will become an essential aspect of an eClinical solution	44
How will electronic health records integrate with eClinical solutions?	44
Go to market	46
Vendors must show how eClinical solutions will streamline the clinical process	46
Provide solutions to make Phase I EDC trials cost-effective	46
In a segmented eClinical market, partnerships are essential	47
Look to integrate essential technologies to reduce redundancy and increase efficiencies	47
Interoperability is the key to the future	47
EDC vendors must provide sufficient training for technology transfer	48
The evolution of clinical data standards will require companies to stay updated	48
Ensure that IT solutions meet government standards for electronic records	49
As clinical trials move to global locations, so should vendors	49
APPENDIX	50
Definitions and Abbreviations	50
Methodology	50
Further reading	51
Ask the analyst	51
Datamonitor consulting	51
Disclaimer	51
List of Figures
Figure 1: Challenges facing the pharmaceutical industry	7
Figure 2: Drug discovery and development process	7
Figure 3: Comparison of paper-based and EDC-based clinical trial process	9
Figure 4: Advantages of EDC over the traditional, paper-based clinical research process	11
Figure 5: Obstacles in adoption of eClinical solutions	14
Figure 6: Percent of R&D IT budget allocated to eClinical solutions in 2007	15
Figure 7: Adoption level of EDC in 2007	25
Figure 8: Summary of criteria to consider when choosing an EDC system	27
Figure 9: Most important criteria for choosing an EDC vendor	28
Figure 10: Summary of strengths and weaknesses of leading EDC vendors	29
Figure 11: Summary of key features that a CTMS should incorporate	36
Figure 12: Summary of strengths and weaknesses of leading CTMS vendors	37
Figure 13: Summary of strengths and weaknesses of leading eClinical suite vendors	41