Important EDC features for medical device clinical trials

Medidata Rave and its CTMS companion product iMedidata are a far more comprehensive solution than OpenClinica but when you choose EDC software for medical device clinical trials, you enter a realm of unique requirements involving connectivity, security, privacy, API integration and specific interfaces to hardware.

Electronic data capture software (EDC software) systems have demonstrated that their value is manifest for clinical trial efficiency and cost savings. Soon, medical device clinical trials will no longer be dependent upon paper-based systems at all. Paper is great for passing notes in class, but how often does that even happen anymore? Kids in school are more likely to use Snapchat or simply text each other.

As someone said recently – “millenials are off Facebook, adults still use email”.

Besides doodling (which can also be easily performed and sent via text messaging on a smartphone), paper is an inefficient means of communicating information to another party. The ubiquity of electronic, cloud-based communication platforms makes the sharing of information more frequent and easy.

CROs play a crucial role in operating clinical trials and meeting milestones. However, effectively having continuous visibility on their work and the quality of the data they provide remains a large concern for Clinical Operations executives.

In this article, we will review how cloud EDC and cloud monitoring can effectively answer these concerns.

Contract research organizations (CROs) charged with clinical trial operations and regulatory affairs for sponsors can benefit from improved data management effectiveness, reduced costs, faster cycle times for closing queries and targeted SDR that reduces their costs while increasing dramatically the quality of data collected in a study.  Although many smaller regulatory affairs and CROs  have traditionally relied upon paper as the primary means for data collection, 62% of CROs believe that the use of cloud-based EDC systems are important for data capture and storage during their clinical studies.

We are not at 100% yet, but we are getting there, and rapidly.

In a reverse example of the Pied Piper story, CROs should follow the children, and utilize technology as much as feasible when operating medical device clinical trial. The instantaneous collection of data and secure storage when using an EDC cannot be underscored enough as a value to clinical data capture.

If you are unfamiliar with EDC, and still trapped in the routine of using the old fashioned paper-based method of data capture, switching to an EDC system may seem scary, as you do not know what to look for, or what to expect. However, EDC systems exist because they are better at capturing data than paper based systems, in every conceivable way.

So, now that you have hopefully been sold on EDC systems, which software features are the most important for your medical device clinical trial? How should you know what to look for?

Let us go over some of the crucial and beneficial software features that an EDC system should contain.

Learnability

Before we even touch upon anything else, CROs should be concerned with the basic learnability of the EDC software they are on the hunt for. No matter how many variables the study is monitoring, how complex and time-intensive medical device clinical trial will be, the first priority feature of EDC should be the initial learning curve associated with operating the software.

What good is the software if your clinicians do not know how to use it?

Most EDC software vendors have a training program in place for new users. That being said, CROs should query vendors with the following questions:

– How long does it typically take for CROs to become familiar with the software?
– Which methods do you use for training?
– How much training is required or is the system friendly enough to be self-service?
– If we missed something, how quickly can you be contacted for follow-up training?
– How much does training cost (if not free)?

There are myriad EDC systems available, catering to small and large scale studies, and no matter whether you are measuring two or twenty variables, to save time and money you need to have software that your team can learn how to use, and quickly. If you are new to EDC, or looking to change providers, learnability is critical for your team’s understanding of the software, what it can do and cannot.

The good news here is that many vendors provide a comprehensive learning program beyond a simple help section in the software. Look for cloud-based EDC systems that allow the vendor to communicate with your personnel in real-time during onboarding.

In an ideal world, you will stumble upon an EDC system software that requires little if no training from the vendor. However, especially if you are transitioning into EDC from a paper-based system, factor in the intuitiveness of the software during your purchasing phase.

Visual UI elegance

The heart of EDC is in its user interface, where clinicians (or in some cases subjects, too) will be spending the majority of their time when on site. The rule of thumb here is emphasis on the simplicity of the UI, that less screens are better.

Simpler is easier. Less is more.

Data managers and study monitors will benefit from the clear and coherent layout of data fields and minimal screens. Also, EDC software that simply looks beautiful in its design will capture the attention of your personnel. Let’s face it: clinical studies are hardly the most exciting, sexiest ways to spend one’s time. An EDC with an elegant UI will motivate personnel.

Drag & drop

In hand with visual UI elegance, the drag and drop features of EDC physical elegance should be noted. Dragging and dropping cards in an EDC platform is the simplest way of capturing data during a study. As opposed to the paper-based standard method of data capture, a cloud-based EDC system provides the ability to drag and drop information within the software. This saves precious time on filing data, because users do not need to transport CRFs anywhere beyond their fingertips.

Subject reminders

Can subjects get active reminders to enter patient-reported outcomes based on clinical events?

On-premise or on-cloud ?

While there is still a number of on-premise EDC software options available, the strength and breadth of cloud services from AWS mitigates numerous risks of on-premise data storage. Many clinical studies take many months, even years. Loads of data is being collected, managed and stored. Not that it happens often, but ask yourself what would happen if all of your data was stored on-site, and your study site was demolished by an earthquake? Nobody knows when disaster will strike.

The feature of cloud EDC software takes the risk of data loss out of the equation. In the worst case scenario, you would have to purchase new hardware and find a new site, but a CRO’s data would still be there, saving time in getting up and running.

Patient compliance or source document review?

The beneficial features of cloud-based EDC and risk-based monitoring are numerous. There is no question that statistical tools such as PCA (principal component analysis) for identifying problematic sites are valuable but are we solving the right problem?

Source Document Verification (SDV) devours more than 15 percent of trial budgets, yet research shows that verifying every data point does not significantly improve data quality.    The answer to this for the big clinical platform technology providers like Medidata has been to provide intelligent techniques of placing SDV focus on problem areas.

I honestly do not understand the value in  optimizing a parameter that provides less than 3% ROI.

Instead, consider shifting focus to optimizing patient compliance – the single most acute constraint in your connected medical device study.

You can save time and costs of data managers and clinical research associates by automating patient compliance deviation detection and response by integrating data collection, monitoring and analysis into one singular premeditated program focused like a laser on optimizing patient compliance.

 

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