When it comes to selecting an EDC vendor, Sponsors usually have different drivers that influence their decision: the intuitiveness and operational efficiency of the system, system quality and technical support and, of course, budget. ARITHMOS has been running a series of market research analyses – including surveys and focus groups – over the last few months to determine what clinical trial professionals consider the essential in an EDC system and if cost and quality are really a paradoxical dream when it comes to selecting an EDC system or if there really is a way to have both.
When it comes to a life sciences application such as an EDC system, most companies need the following: a configurable system able that is cost-effective in terms of function and management and in cloud computing mode.
If we look at these three factors individually, we’ll see how this type of EDC system can meet both operational and budget requirements.
The concept of configurability applies to both the operational effectiveness of an EDC system and the overall impact on the study budget.
Through our market research, we found that many clinical trial sponsors value configurability in an EDC system to allow them to implement the features useful to a particular study. A customizable Life Sciences application can be a middle ground between COTS (Commercial Off-the-Shelf) software and custom software. COTS can have operational and financial drawbacks such as too many or not enough functions, high licensing costs and costly support services. Since not all study characteristics and budgets are the same, configurability allows:
- Paying for functions needed and not paying for those not applicable to your study
- Ability to reuse the application with slight modifications
- Reuse of documentation to reduce costs
- Training effort reduced due to high usability
- Sponsor and site personnel use the same application for different projects
Sponsors can attest to the fact that no matter how prepared one is in the beginning of a study, there are always little modifications to make as the study goes on. The added value of configurability is the ability to customize solutions and make modifications without impacting the data already collected and not having to revalidate.
An EDC system can come at low budget prices with baseline technology and functions. However, Sponsors are now requiring cost-effective solutions “without the bells and whistles”. Sponsors want the option of having a basic system with principal functions and pay for additional features if and when necessary. This gives the Sponsor full autonomy to manage his/her budget. Additionally, clinical trial personnel should be able to build a study and manage study data independently through an intuitive, user-friendly system.
Lastly, sponsors are now looking for EDC systems in Software as a Service (SaaS) cloud computing mode. The advantages are clear: no hardware/software installation or IT infrastructure investment, faster trials, more efficient data management and better data quality and better global study organization.
To reiterate the first point on configurability, cloud-based solutions come with a great deal of flexibility: allowing reuse of the application, reduced training efforts and ease of managing study personnel credentials. Cloud-based solutions also allow for customizable, real-time reporting tools that can be integrated with devices such as smartphones and tablets promising accurate, up-to-date data anytime, anywhere.
How does this affect your budget? Reports have demonstrated that cloud-based EDC can speed up clinical trials by up to 30% which can lead to around $400 million USD in cost savings. You can also factor out computer system installation and maintenance which can cost companies up to $2 million USD plus additional costs for technical assistance.
ARITHMOS and Symphony EDC
This week, ARITHMOS announced a roadmap for the development of Symphony EDC, Software as a Service (SaaS) intuitive electronic data capture solution which contains the basic functions of an EDC and also allows for easy study build and management without needing external support services. This allows Sponsors to meet strict budget requirements for any kind of study.
See why Symphony EDC is also a configurable system able to coordinate various tasks, functions and documents in cloud computing mode: ARITHMOS Announces Roadmap for Symphony EDC System