ECLINICAL TECHNOLOGY SELECTION: CONFIGURABILITY, COORDINATION, CLOUD

When it comes to selecting eClinical applications and technology – such as EDC systems, CTMS, IWRS and even data visualization tools, 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. CROS NT has run a series of market research analyses this year to determine what clinical trial professionals consider essential in eClinical applications and if cost and quality are really a paradoxical dream when it comes to selecting a technology or if there really is a way to have both. When it comes to a life science application, most companies need the following: a configurable system able to coordinate various tasks, functions and documents in cloud computing mode. If we look at these factors individually, we can see how Sponsors can select an eClinical application to meet both operational and budget requirements.

Configurability The concept of configurability applies to both the operational effectiveness of an eClinical technology and the overall impact on the study budget.

Through our market research, we found that many clinical trial sponsors value configurability in an eClinical application to allow them to implement the features useful to a particular study. A customizable Life Science 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 budget 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 the 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 data already collected and not having to revalidate.

Coordination An eClinical application can come at low budget prices (or even free via open source) with baseline technology and functions. Sponsors have noted the importance of coordination. For example, Sponsors may require an EDC system not only for data management but for edit checks and tracking deviation management, and more importantly for managing essential documentation, study startup progress and tracking metrics. In many cases, data comes from various sources such as different sites, core lab data and other outside sources.

eClinical applications should now be able to coordinate and integrate data into a single place – one single source.

Cloud Lastly, Sponsors are now looking for eClinical applications offered as a Software as a Service (SaaS). The advantages are clear: no hardware/software installation or IT infrastructure investment, faster trials, more efficient data management and better quality data 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 study budget? Reports have demonstrated that cloud-based eClinical solutions 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.

CROS NT and eClinical Applications CROS NT can 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. For more information on our eClinical technology offerings, visit the technology section of our website.