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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

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