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

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.

Report 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.
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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
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