The 3 C’s of EDC System Selection: Configurability, Cost-Effectiveness, Cloud

doctor holding smartphone with medical appWhen 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.

Configurability

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.

Cost-Effectiveness

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.

Cloud

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

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In Copenhagen, Technology is the Focus of Nordic Life Sciences Events

Next week, ARITHMOS is in Copenhagen to sponsor to life sciences events that focus on evolving trends in the clinical trials sector – pharmacovigilance and Risk-Based Monitoring. Technology takes center stage when looking to implement solutions that can ensure data quality, improve efficiency and cut costs.

Nordic Pharmacovigilance Day
7th of October – Carlsberg Museum & Business Centre in Copenhagen, Denmark

????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????Pharmacovigilance Day focuses on “designing an efficient pharmacovigilance system” and how the use of electronic systems can help companies achieve the effective safety system required by law, especially under the new GVP guidelines.

ARITHMOS has pointed out before that the system you choose should be compliant with global adverse event reporting standards as well as with standards of main regulatory bodies. For example, the EU has relased good pharmacovigilance practice guidelines (GVP) which focuses on “proactive and proportionate risk management”, higher quality of safety data and “strengthened transparency”.

  • Does the system have technologically advanced reporting tools?
  • Is the system intuitive?
  • Is the system available in the cloud?
  • Does the system have the appropriate coding functions?
  • Who will take care of the hosting, validation and maintenance?

Speaking of pharmacovigilance in the cloud, Pharmacovigilance applications should be accessed through the Internet with minimal IT effort through web browers with no installation required on a PC. Another option is to publish the application in Citrix with only a plugin to install. A cloud computing and SaaS solution is a valuable technological trend for efficient application delivery. The burden on the customer is reduced in terms of hosting and maintenance and the default configuration meets standard business processes. This solution is flexible to changing business and operational needs and guarantees an efficient and cost-effective solution.

 

Nordic ePharma Day
8th of October – Carlsberg Museum & Business Centre in Copenhagen, Denmark

At Nordic ePharma Day, the topic on the table is Risk-Based Monitoring the role of technology in supporting the transition from the “common” to the Risk Based Monitoring.

Centralized Monitoring has been proposed as a new, more efficient and cost‐effective approach to on‐site visits. A CSM approach performs data quality checks on all trial centers at the subject and site level. Statisticians can then analyze the data in real time to identify sites that need further investigation due to unusual data patterns. In a CSM strategy, many discrepancies can be improved by implementing cloud‐based technology solutions. Clinical Data Visualization and analytical business intelligence tools should be considered to query the EDC database and design reports for the main personnel involved in the trial review that assess site activity for quick analysis and decision‐making. Tools available today are generally cloud‐based which means Sponsors avoid the technology hassle of HTML or plug‐ins and enjoy the convenience of data “on the go”.

ARITHMOS is pleased to sponsor both of these Nordic Life Sciences events and promote the role of technology is these life sciences trends. If you are interested in attending these events, please visit the event websites. If you have a need for technology solutions in pharmacovigilance or Risk-Based Monitoring, please contact ARITHMOS for an RFP.