WHAT IS THE “IDEAL” EDC SYSTEM FOR A CLINICAL DATA MANAGER?

Conducting a clinical study requires the collection of a large amount of data that can be entered, checked, confirmed and finally grouped together in a single database. Setting up a central database and electronic collection via the Internet called eCRF (electronic case report forms) meets these needs by combining technology, simplicity, privacy and data security. According to a study by CenterWatch, if the market continues to adopt EDC and ePRO technologies, paper diaries will no longer exist in 10 years. Should paper diaries still be used to collect subject data in clinical trials? CROS NT’s expert Clinical Data Management team discusses this issue and what the ideal EDC system is for data collection.

There are several challenges to using paper CRF: Massive amount of paperwork Tedious for Investigators – repetition, data transfer, consistency Tedious for Monitors Logistical issues All data must be transcribed Data cannot be evaluated in real-time More time and effort needed for data cleaning Extended timelines from LPLV to DB Lock

eCRF significantly reduces the time and costs for certain stages of a clinical study. Direct and indirect costs can be reduced thanks to parallel operations during the use of a centralized database that can be accessed simultaneously by many people using the Internet. Choosing the Ideal EDC System Conducting studies in accordance with industry guidelines like ICH and GCP leads to reporting and documentation requirements that are burdensome and complicated. There is no real guidance from regulatory agencies on how to evaluate the many EDC systems available. The availability of cost-effective, open source or proprietary EDC applications have the potential to improve clinical and research activities. User-friendly and simple interfaces, adherence to industry standard security protocols, customization and low maintenance costs are some of the major

benefits. Commercial EDC systems can be expensive in comparison to open source or proprietary EDC systems. It is important to evaluate and find the functions that best fit data management needs. What do Data Managers want in an EDC System?

An EDC sytsem compliant with regulatory requirements: audit trails, data validation, system integrity

A system than enhances communication and sharing with users Flexibility to allow for study specific customizations and dynamic forms Intuitiveness and user-friendly system that is easy to navigate Intuitive to select visits and enter data for end users Easy to retrieve data queries Efficient data cleaning and easy to update

Easy for study monitors to perform and mark SDV Easy for Investigators to sign when CRFs are complete

CROS NT can also offer a cloud-based eClinical application which is an integrated platform of EDC/ePRO/IWRS/CTMS. Combining an eClinical platform in the cloud with a centralized approach to clinical data, Sponsors can reduce set-up, training and HelpDesk costs and allow for easy data integration. A cloud-based solution allows for real-time study management access to data from mobile devices.