The accessibility and quality of data in decentralized or hybrid clinical trials is essential across many areas of study, and is vital to a study’s success. An enterprise platform promotes organization in all hybrid and fully virtual study activities. A credible system is going to have a few important components that provide all clinical trials with accessible, higher-quality data.
- Data Storage and Hosting
- Patient Experience
- Data Integration
1. Data Storage and Hosting
This is an essential part of the clinical trial process because crucial study data should be centrally accessible from multiple systems, at any time. That accessibility is going to provide the most convenient option, and the most effective data sharing opportunities for decentralized teams. Each time a change is made to data it will be synced and updated across all of your eClinical products, and made available right away.
There is also encryption, which is especially important based on the nature of the data you are using. It mitigates risk for exposure of information related to your patient resources. You want to ensure that this specific data is secured, and that you are not compromising the care and well-being of your participants by exposing their data. This means end-to-end encryption across all of your data.
In addition there are a number of regulatory related compliance standards that your products and practices should adhere to such as HIPPA, CFR 21 Part 11, and GDPR standards. Without these in place, you are putting your patients at risk. You want a system that allows for data collection from the app or web, which is integrated with, or is an extension of an electronic data collection (EDC) system, and that effectively secures Patient Health Information (PHI) from all possible angles. The Datatrak Enterprise Platform allows for data to be collected from apps, devices or web as an extension of our EDC, keeping it compliant and safe.
2. Improving the Patient Experience
The benefits that come from a platform that provides a centralized data approach are not just limited to one area of your study, but they branch out and provide a wide range of advantages across many aspects of the trial. This includes your patients. When evaluating or determining the right solution for your decentralized or hybrid trials, the patient experience is extremely imperative.
Patients, at a basic level, should have access to provide data entries on their own, from a device they are comfortable with, from anywhere. In today’s world, the ‘from anywhere’ part is paramount. It should be easy for them to understand what is expected of them, and easy for them to provide the data needed. Datatrak Direct, our ePRO, eCOA and eConsent solution, allows patients to download an app that is secure and easy-to-use. It can also notify them when forms are due not just by email, but with app notifications too. This small feature not only keeps your studies on track, but ensures that the patient stays engaged.
With Datatrak Direct, study staff can also easily create forms and configure the frequency at which they appear to patients. An ePRO solution should allow studies to provide video and other helpful content, not only as part of the consent process, but throughout the trial. This keeps patients satisfied, and completely informed in the simplest ways.
3. Seamless Data Integration
It is important to get data aligned as quickly as you can so that the dominos fall as smoothly as possible down the line. With a divided system, you don’t have the advantage of obtaining patient or other entries in real time. Details are not going to be immediately available to key members of the trial process as they would be with a centralized platform. This means having to wait for results and to review data.
Another impact of having a delayed outcome, is less collaboration amongst your team members and patients. This can also lead to higher cost on several levels. You not only incur higher costs when you’re managing and monitoring multiple systems and possibly vendors, but there are likely overhead and additional costs to address the inconsistent formatting and points of failure you’ll in inevitably be faced with.
If your EDC tool is not seamless with your virtual tool, you introduce the possibility of irregularities throughout your trial data. Mapping data from one tool to the next can become complicated and you introduce possibilities for the data to be mapped incorrectly or be misunderstood unintentionally. With a centralized system you are going to have more standardization across the board.
As you start decentralizing your studies with remote workforces, the need to ensure your study teams collaborate and work together becomes even more imperative. Communication becomes key when people and patients are dispersed around the world. One of the main differences within our Datatrak Enterprise Cloud Platform is the ability to unify study teams and applications to prevent service delivery gaps and redundant systems.
It is important to have an eClinical solution that can improve your ability to communicate, not one that adds additional steps or processes. Through our collaboration tools including central calendars, announcements displayed at the first system login, patient notifications through push & email notices, immediate safety emails, and many more, teams can work the way they want by providing open, intelligent workflows to create seamless experiences for disparate teams.
When using multiple products, like EDC and ePRO, the design should be streamlined, not duplicated. The Datatrak Enterprise Platform allows you to design the data collection fields you want in the EDC, and create those within the iOS and Android apps. You then can use the flexible tools to engage with the patient, giving them easy data entry options. Any technology you utilize should empower your study team to manage their workflows and the design themselves, with a seamless experience.
Would you like to learn more on how Datatrak can help you with your decentralized or hybrid studies? Watch our webinar, visit our Datatrak Enterprise Platform page or contact one of our experienced team members today.