You’ve made the decision to go EDC over paper. Now you must decide the appropriate EDC vendor for your study. There are many factors that influence this decision including study phase, therapeutic area and indication, patient enrollment and, of course, budget. Therefore, how should a study Sponsor make this important decision? Arithmos takes you through a small checklist of criteria to evaluate.
Before any study gets underway, a budget is determined which includes costs for technology. Determine your budget for EDC system keeping in mind that there are EDC systems which allow for a pay-as-you-go option. It’s no secret that pharmaceutical and biotech companies are looking to cut drug development costs, but this does not mean choosing the cheapest EDC system on the market.
Determining the EDC budget should be based on a cost-benefit analysis of the EDC system’s functionalities versus the study’s needs.
Now that you have an idea of your budget for an EDC system, analyze how intuitive the system is. According to an Arithmos survey on EDC usage, there are several factors that would hinder the use of EDC, including:
- Too time consuming
- Technical problems
- Familiarity with EDC technology
Sponsors are going to want to choose a system with an intuitive interface and easy to use platform to minimize the risk of non-compliance by Investigators of patients or misuse during the study.
3. Operational Effectiveness
Evaluate EDC systems to make sure they have the functionalities that are vital to the success of your study:
- Can you build your own study?
- Are there data entry, coding and randomization features?
- Are there Project Management tools?
- Are there customized reporting features?
- Are there re-usable templates and forms?
- Is the system compatible with GCP and/or regulatory guidelines? Is there an audit trail?
- Can the system handle multicentre, global studies?
4. Integration with ePRO
For collecting data electronically, typically a PC was used on site for all patients. The market is now shifting towards individual, handheld devices which patients can use from home. Internet connection allows data transfer as well as doctor-patient communication.
According to Arithmos’ survey, more clinical trial leaders would be open to EDC if it could integrate data from ePRO devices.
5. Technical Support
Find out if your EDC system has technical support – including HelpDesk services and training. Training is essential for those who will be using the system to avoid error.
HelpDesk should be available – via telephone or Internet – in order to resolve any technical issues immediately.
Arithmos can assist clinical trial leaders with the selection of an EDC system by working with study requirements and budget restraints. The Arithmos team is very proficient in working with EDC in terms of installation, validation and customization, including integration with other data sources. For example, we have designed simple and intuitive EDC systems using OpenClinica for post-market studies, installed and validated Oracle RDC, integrated spirometry devices with EDC, and integrated mobile phone and tablet ePRO data with eCRF. Arithmos has also developed a simple and inexpensive EDC technology platform to effectively manage clinical trials and collect patient data electronically. This low-cost EDC solution is accessible via a Web browser using secure log-in credentials.