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

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