At ARITHMOS‘ eCRF Symposium this month, the Director of Clinical Data Management for an international CRO, gave a presentation on the ideal EDC system and what functions are necessary for successful data management. Monica Pimazzoni has over 20 years of experience in clinical data management for both large pharmaceutical companies and in the CRO environment, and she shares her opinion of the ideal EDC system.
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. These steps require significant logistical means in order to comply with the GCP (Good Clinical Practice) and regulations on the protection of people’s safety and well-being. Setting up a central database and an electronic collection via the Internet called eCRF (electronic case report forms) meets these needs by combining technology, simplicity, privacy and data security.
What are the challenges of using paper CRF?
- Massive amount of paperwork
- Tedious for Investigators – repetition, data transfer, consistency
- Tedious for Monitors
- Tedious transport and archive activities
- 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. eCRF ensures:
- Privacy and security (password login, encrypted data, secure protocol)
- Source data collection by the users (no double entry)
- Effective and immediate communication between participants
- Optimization of site visits by upstream preparation
- Significant reduction of data collection errors through input controls
- Remote monitoring
- Better data input quality
- Interim analysis that can be implemented quickly with snapshots of data exports
How to choose an EDC system:
In Europe, it is a legal requirement to conduct clinical trials in accordance with the International Conference on Harmonisation’s guidelines on good clinical practice. This leads to reporting and documentation requirements that are burdensome and complicated. There is almost a complete absence of guidance from regulatory agencies about how to evaluate the many EDC systems available.
The availability of cost-effective, open source or proprietary EDC applications for individual physicians/researchers, departments and institutions has the potential to improve clinical and research activities. Since further development/customization and ownership costs are lower, Sponsors can modify and adapt EDC systems to suit their environment and workflow, thus ensuring the success of EDC implementation. User-friendly and simple interfaces, adherence to industry standard security protocols, customization and low maintenance costs are some of the major benefits.
Cost is an important, if not the most important, factor to be considered while choosing an EDC system. Although the nature of licensing and support required to maintain EDC systems are the main predictors of cost, data capture and workflow at the site of implementation also have a major influence.
Commercial EDC systems can be expensive in comparison to open source or proprietary EDC systems. It is important to evaluate the cost-benefit analysis of each EDC system and find the functions that best fit your company’s needs and budget.
What do Clinical Data Managers Want?
- An EDC system compliant with regulatory requirements: audit trails, data validation, system integrity
- A system that 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
ARITHMOS has various EDC solutions available depending on the Sponsor’s needs and budget. Sponsors can meet with one of our business and application analysts to define user requirements. ARITHMOS can also support licensing, implementation and maintenance needs for various EDC systems as well as provide ongoing support in terms of HelpDesk and eLearning.
ARITHMOS also offers a proprietary EDC system, Symphony EDC, which is an affordable system that covers the main functions for data collection and reporting and can be customized based on study needs.