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Identifying the Right EDC Solution for Today's Clinical Trials

By Pharma Tech Outlook | Thursday, November 15, 2018

With ample electronic data capture (EDC) systems available in the market today, it has become difficult for organizations to identify the one that is apt for their business needs. Additionally, the rapid pace of technological advancements, increasing complexity of trial protocols, and the growing requirement for multiple and varied data sources, is making it arduous for businesses to identify the right data capture solution. Therefore, prior to making a purchase decision on an EDC solution, it is essential for a buyer to carry out some analysis, and the key factors to be considered include performance, cost, and the flexibility of the system, and its compliance with regulatory requirements.

Cost-effectiveness is paramount. Organizations should clearly outline their budget prior to approaching potential EDC solution vendors. In terms of pricing, EDC systems run the gamut, from being free of charge to highly expensive. One of the many benefits of utilizing EDC is, money can be saved in the long-term. Hence, while choosing a suitable EDC system, it is critical to compare pricing across multiple vendors.

Unique challenges are likely to occur throughout the course of a clinical study, and hence choosing an EDC system that is able to rise to these is vital. EDC platforms should be intuitive, simple to understand, and easy to configure. Buyers must ensure to audit and catechize about different aspects the EDC system like design, ability of data collection, formatting to be applied across multiple protocols, and edit checks that can be built into the platform. Alongside, it is also critical to know precisely how data can be obtained, stored, and exported in the EDC. Only if these conditions are fulfilled, the EDC solution is a probable fit.

Another crucial aspect that has to be kept in mind while choosing an EDC solution is compliance. Hence, it is imperative to ensure that the system is compliant with 21 CFR Part 11. Together with that, one more factor to be considered is the EDC system’s integration capabilities. Integration between an EDC system and other research solutions, such as clinical trial management system (CTMS), can reduce duplicate data entry and eventually increase data integrity and streamline research workflows.

Therefore, clarifying all of the aforementioned points before making a purchase will avoid unnecessary expenditure of resources. Above all, organizations must take time and conduct a thorough review to find the solution that best fits their business needs. 

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