Electronic Data Capture and Management: Assessing Opportunities to Streamline the Clinical Trial Process - Market Research Reports - Research and Markets

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Electronic Data Capture and Management: Assessing Opportunities to Streamline the Clinical Trial Process

Description:

Introduction
Electronic data capture (eDC) technology will improve the quality of data collected at clinical trial sites by reducing errors inherent in the current data collection system. Pharmaceutical companies looking to adopt eDC technology should choose an eDC vendor that is able to demonstrate global scalability, as well as offer an integrated end-to-end clinical data management solution.

Scope
Analyzes the evolving eDC market, including general strategies for assessing eDC vendors
Defines characteristics of eDC vendors that are important to long-term stability in the market
Explores the challenges companies will face when switching from a paper-based to an electronic data capture-based clinical trial process
Looks at current industry leaders operating within the eDC market, including their best practices and opportunities for improvement
Highlights
Electronic data capture can provide better data and a more efficient clinical trial process, including improvements in data quality, a streamlined review process and ultimately faster time to market. By reducing the length of the drug development process, sponsors can increase the return on their investment and better distribute their resources.

Market growth is likely to take place slowly and unevenly as companies move out of the pilot phase. One important barrier to market stabilization and wide-scale adoption of electronic data capture technology is the difficulty that vendors have developing solutions well-suited for the wide range of companies operating within the industry.

As the regulatory environment moves towards standardization of the clinical trial process and as clinical trials grow in scope and size, the eDC market will likely narrow to include less than half-a-dozen financially stable vendors that offer end-to-end solutions.

Reasons to Purchase
Understand the current and prospective electronic data capture vendor market and where the key opportunities for your company lie
Recognize how implementing a robust and integrated electronic data capture process is critical to preparing for future FDA eSubmission initiatives
Understand the limitations and opportunities offered by each vendor and hasten eDC adoption by choosing the best vendor for your data capture needs

Contents:

TABLE OF CONTENTS
ACTION POINTS 6
Outline of the brief 6
Three key things you need to know about the electronic data capture market 6
Wider scale adoption of eDC technology by the pharmaceutical industry will not occur until eDC vendors offer scalable solutions that make sense and are affordable for not only large global pharmaceutical organizations, but also smaller pharmaceutical and biotechnology companies 7
Pharmaceutical companies seeking to adopt eDC technology should use the services of those vendors that offer end-to-end eDC solutions, as these vendors will ultimately succeed within the electronic data capture and management market to the detriment of most, if not all, point-solution eDC companies 8
As it is inevitable that the FDA will ultimately require drug development data to be submitted electronically, the eDC industry must work with regulatory agencies to move towards standardization of electronic submissions to facilitate the drug review process 9
ELECTRONIC DATA CAPTURE AND MANAGEMENT 10
Introduction 10
Electronic data capture: paper vs electronic 10
Applications of electronic data capture 14
Data-entry direct to central database 14
Clinical trials: Phases II and III 14
Post-launch marketing: Phase IV 15
Regulatory surveillance 16
The current market for electronic data capture 17
Size of the electronic data capture market 17
Penetration of electronic data capture 18
Best practices in the application of electronic data capture 19
Types of vendor business models 20
Application Service Provider 20
Licensing 21
Current approaches to electric data capture 22
Wired computer stations 22
Wireless technology 22
Vendor market 24
The market leaders 24
Oracle 24
Phase Forward 26
Key market players 28
eResearch Technology 29
LifeTree Technology 30
Medidata 30
etrials Worldwide 31
DataTrak International 32
Selecting a vendor 33
THE FUTURE DECODED 36
Outlook for electronic data capture 36
Conclusion 37
APPENDIX 38
List of figures 38
Research Methodology 38
References 39
Relevant links 39
How to contact experts in your industry 40

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