Empowering Clinical Research with the Right EDC system

Pharma Tech Outlook: Pharma Tech Magazine

Empowering Clinical Research with the Right EDC system

By Pharma Tech Outlook | Friday, August 17, 2018

There exist many different electronic data capture (EDC) systems in the market, making it difficult to find a system that is the best fit for your organization. While it is easy to be lured by attractive special features that many EDC systems offer, it is important to note whether they can be used effectively or not. Choosing the right EDC system can empower firms to research their own terms, but there are some points that have to be kept in mind while evaluating an EDC system.

Functionality: When selecting an EDC system, it is important to ensure that the software provides the right functionality for your operations. Analyze the needs of the clinical trial, everything from case report form (CRF) creation to data export needs to be in line with your end goals.

Ease of use: Always opt for a solution that is easy to use and has an intuitive design. A demo should be scheduled prior to purchase to get an accurate assessment of the EDC system. It will also benefit the participants of the study if the EDC system features a straightforward setup protocol, accurate data entry, and efficient query management.

Compliance: For a system that holds clinical data, which has to be submitted to the US Food and Drug Administration agency, ensure that the EDC system fully supports compliance with Title 21 Part 11 of the Code of Federal Regulations.

Implementation: Consider whether the EDC system needs to be installed and managed by an IT department or is it a hosted system where the vendor is responsible for data backup and security.

Training and Support: What is the amount of training required to start building clinical trial studies? Does the EDC system include on-going training and immediate help? Also, check whether the vendor includes extra fees for both customer support and technical support.

New features: Will the new versions of the software include your feedback and also from other members of the user community? Does the vendor strive to create vendor-client relationships to improve the software and fulfill customer needs?

Pricing: While many vendors have attractive pricing, hidden service fees may cause a problem later on. It is best to determine the actual cost of the EDC system and ensure a clear understanding of all the related expenses.

System Integration: Does the EDC system integrate with other systems such as a clinical trial management system? Seamless integration with other systems can reduce duplicate data entry, increase data integrity, and streamline research workflows.

Before purchasing an EDC system, it is important to research and compare different vendors and their products, taking into account factors beyond functionality. Through a thorough review of each vendor, find a solution that best fits your needs, and will help manage clinical trial studies.

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