How to find an Electronic Data Capture (EDC) software for your study
This article gives the reader a basic understanding of what EDC software implies, what you should keep in mind when assessing an EDC vendor and how it can benefit the results of your study/clinical trial.
What is an Electronic Data Capture (EDC) software?
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An EDC software is a tool that will help you capture, store and process data that is gathered during an experimental study or clinical research. These EDC software packages are very different from one another as they usually have a certain field of speciality. The majority of EDC systems captures data from (electronic) Case Report Forms (CRFs) which eliminate the need for paper forms which demand double data entry and are subjected to a higher risk of data capture mistakes. Pharmaceutical companies, or often CRO’s, and research sites use these systems to conduct clinical trials ranging from Phase I to IV and even post-marketing studies.
How can EDC software help me save time and money?
Using an EDC software you will be able to reduce your time drastically both during the study as well as preparing and creating the study.
By designing eCRF with an EDC software you eliminate immediately the need for copying and creating electronic copies for statistical analysis. The more data is touched by human interactions, the higher the chances that mistakes are made and the more time will be lost cleaning data. Using predefined data entry limits, data entry methods and error messages that indicate possible discrepancies help reducing data entry errors.
Also on a study management level time can be saved by tracking mistakes in CRF early and analyzing the query management per site or per CRF. By creating custom reports, clinical data managers can analyze which forms receive on average more queries indicating an unclear question, an error in the CRF design or other mistakes that can be adapted in real-time to avoid unusable data.
Investing in an EDC software will be a substantial investment at time 0 though the cost-saving efforts will result in less expenses in the long run. Managing your study in real-time avoids unnecessary costs because of study errors and redesigning CRFs. The use of online randomization and according drug management module eliminates the cost of external data statistician to create randomization lists and handling costs for drug management.
How to evaluate an EDC vendor and its EDC software?
EDC system evaluation
The EDC software should have certainly a couple of basic features that will help you guide your study to a good ending.
- Designer module: Make sure that the EDC software has multiple data entry possibilities that will be able to recreate the CRFs to your screen. The more possibilities, the better. Also make sure check for multi-lingual capabilities and the possibility to work with form libraries.
- Reporting: The software should provide certain standards reports to track your studies as well as the freedom to create custom reports. Data queries should be linked to this reporting module to track recurring errors in CRFs.
- Administrator module: The ability to create user groups, restrict and grant access to individuals including an extensive audit trail that tracks log-in session and changes to the CRFs so data of patient is securely stored and can not be tampered with.
- ePRO, Web Surveys, Patient Diaries: The alternative methods of data capture have shown to register more accurate (and frequent) data coming from the Patient’s perspective. An ePRO module (including web surveys and patient diaries) is an essential feature that all EDC system need today.
- Randomization and Drug Management modules: As mentioned before, these two modules eliminate the use of external personnel to handle patient randomization and double-blinded drug distribution.
- Batch upload: Linking existing data to the newly gathered data should be a process of a couple of clicks by using a batch upload feature that links system columns automatically using an upload wizard
DACIMA CLINICAL SUITE is an easy to use software with all the required components to manage the study data autonomously. Nicole Lupien, MIREC Study Coordinator
EDC Vendor evaluation
An excellent EDC software does not assure a smooth and streamlined process of Data Capture. The EDC vendor should be able to offer multiple services that will help the research organization trough the study.
The ability to understand the needs and requirements of the researcher is the most important criteria for choosing an EDC vendor. The software should be able to be tweaked for specific requests and eCRF design services are required for rapid adaptations.
Looking for a user-friendly EDC software?
Dacima Software offers a easy-to-use state-of-the-art Electronic Data Capture software with multiple Clinical Data Management tools that can and will help you save time and money conducting your studies.
Founded by researchers, we are perfectly placed to understand your needs and requirements and are ready to adapt our software to your study.
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