Organizations that conduct clinical research are constantly facing the challenge of maintaining a high level of quality data while working with tight budgets. The “non-profit” organizations such as academic research organizations, hospitals, associations and foundations are seeing a decline in the number of studies being conducted. Even companies in the biotech, medical device and small to mid-size pharma sector face budget restrictions or lack of funding, and therefore are limited in the research they can conduct.
Therefore, the outcome seems to be an increase in “low-budget studies”. In this case, what are the requirements for eCRF and EDC systems? Do they vary by industry? ARITHMOS looks at these factors in anticipation of its upcoming event – “eCRF Symposium”.
Even if the study budget has been defined as “low budget”, many companies and organizations can still implement eCRF and EDC systems that meet their budget and study requirements. What are the requirements that companies should be looking for in an EDC system?
Does the system have a pay-as-you-go option?
There are EDC systems that allow you to pay for the functions used and on a pay-as-you-go basis. This is ideal for non-profit organizations and small companies who really need to micro manage their budgets.
What is your functionality checklist?
- 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 regulatory requirements?
- Can the system handle multicenter, global studies?
- Can the system be integrated with ePRO?
At this point, study Sponsors can cross check their study requirements with budget requirements. Is there a system that covers my requirement checklist and has a pay-as-you-go option? (See ARITHMOS’ Symphony EDC system)
There are, however, additional factors to take into consideration when determining eCRF and EDC needs which can factor into overall budget.
How long does implementation take?
Is implementation time a driver in your overall decision? The system provider should perform a user requirement analysis and determine timelines for implementation that fit your study timelines. Any delay in the study could also effect your budget.
What additional services does the system provider offer?
If price is the main driver in your EDC selection, there are additional factors that could increase your costs if they are not considered beforehand:
- Does your system provider offer hosting and backup services?
- Is training available by the system provider?
- Is their technical support available in the form of a HelpDesk?
While low-budget studies might all consider price the main driving force behind an EDC decision, each sector most likely has its study requirements that need to be compared to price requirements. For example, do Academic Research Organizations require the same functions in an EDC system as medical device companies? Once a budget is defined, which factors become the main drivers – implementation time? Primary functions? Intuitiveness? Accompanying services?
ARITHMOS’ eCRF Symposium (Simposio sulla Scheda Elettronica) aims to distinguish eCRF needs in various industries and find the commonalities and the differences. The symposium, which takes place on the 10th of April in Milan, features a panel of speakers from academic institutions, hospitals and CROs to discuss individual sector needs and what is missing.