Clinical Trials - Future Trends
Clinical Trials have been gaining prominence off late. Often Clinical Trials procedures and processes are assumed to be complex due to the structure in practice. However there have been lot of speculation pertaining to these procedures and processes related to clinical trials. This introspection has began along with the time and change in the levels of technology. The detailed level of existing procedures create a complex environment due to its huge way of performing things which calls for the best accuracy and concentration to handle things.
To maintain this accuracy and concentration, a clinical trial needs to depend on huge number of people in the paper based environment. The manual process was always time taking and costly. This confusion as the technology has evolved started having a glimpse to make use of technology and automate certain process which would take time and also would be cost effective. This technology has the capability to keep itself intact the most required accuracy, quality and efficacy.
The regulatory authorities noticing this trend in clinical trials have come out with few guidelines for the usage of software in clinical trials like EDC for data capture, SAS for Analytics and Reporting, eCTD for common standard of submissions and more in compliance with 21 CFR Part 11, CDISC standards, HL7, ICH guidelines.
Today many organizations associated with clincal trials are making use of these softwares available from good vendors. These softwares help us in automating the part of the process related to clinical trials and helps us in saving time and cost, preserving accuracy. This is the situation of change that clinical trials over the years have witnessed.
For Clinical trials now and in future.....whats next!!! whats in store!!! whats the road ahead????
Please contribute your thoughts in terms of the future trends of clinical trials with respect to procedures, process, softwares, Regulatory and all other related issues....
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