Electronic Data Capture(EDC) is used to help medical device and pharmaceutical organizations accomplish the greatest effectiveness with regards to entering data, structuring a database and conducting analysis for clinical trials. EDC technology has developed as past worries about data integrity through human error and connectivity issues caused by less reliable IT systems have become a thing of the past. In the course of the most recent decade, the utilization of EDC in clinical trials has become more prominent. As the medical industry embraces new technologies and innovations, including electronic record keeping, the volume of information collected before, during and after the clinical trials continues to grow. As such, comprehensive data collection and efficient management is now becoming a priority for pharmaceutical companies and clinical research organizations (CROs)
Benefits of using Electronic Data Capture:
Collecting valuable data from clinical trials in paper form can be Ease of set up, data quality and more secure. Electronic data capture (EDC) is a way to receive high quality clinical trial data. It is important to understand the advantages of EDC and how it is improving clinical trial studies:
Ease of set up:
Configure studies in days, not months with our simple and inbuilt interface without depending on programming. Setting up a complete clinical study in an EDC system can be relatively easy, depending on the system you choose.
Improves data quality
Clinion EDC software is a great tool to create and store electronic case report forms (eCRFs). This ensures that the data collected is accurate, flagging errors or results falling out of predetermined parameters. Programming edit checks into eCRFs prior to data entry prevents unnecessary or insignificant data from being caught and makes sure that only logical values are recorded.
Accelerates study completion
An EDC system allows studies to be completed quicker because it streamlines the work required to conduct a trial. Forms are created, data is entered, queries are resolved, and data is locked all in one system, in real-time. This reduces the waiting and/or travel time for monitors, data managers, and coordinators, and the sooner they complete their part, the closer a study can be to completion.
Makes it easier to find what you need
An EDC system allows authorized users with an Internet connection to remotely access clinical data from any geographical area. You can spend less time worrying about where to keep your forms because patient data is safely stored and backed up in a cloud-hosted system. Since all forms are available in one place, it is also easy to reuse one across multiple protocols.
Is more secure
Data recorded on paper can be altered in a manner that’s nearly impossible to detect. An EDC system has audit trail functionality, in which every change is tracked. Since patient safety is a huge concern, data can only be accessed via role-based permissions in an EDC system. Electronic signatures requires a unique username and password to log in and perform certain actions. An EDC system must have many technical controls in place to be compliant, including 21 CFR Part 11 guidelines put forth by the FDA. To complete the validation process, you have to start with a validation ready system.
Clinion provides a fully featured, 21 CFR part 11 compliant EDC solution, giving both investigators and monitors a powerful yet easy-to-use environment for data entry and monitoring. Clinion supports all the steps of the clinical trial process from translation of the clinical trial protocol to the consolidation of all collected trial data, ready for reporting and analysis. It is available online and can be securely accessed from anywhere by authorized users. Clinion EDC Features all relevant ISO certifications this to its user:
- EDC & Paper Studies
- eCRF Designer with Global Libraries
- Document Repository
- SDTM Compliant
- Medical Coding & Multilingual CRFs
- Discrepancy Management
- Cloud-Based SaaS – Pay per use model