Making Life Easy for Study Teams with a Better Approach to eCOA
In the world of clinical research, efficiency and precision are paramount. Traditional methods of delivering ePRO and eClinRO studies have long been marred by cumbersome processes, extended timelines, and a lack of flexibility. However, innovative solutions are now reshaping the way clinical research is delivered. In this blog, we’ll explore how the redesign of ePRO and eClinRO systems is simplifying workflows and providing a better experience for study teams, sites, and patients.
Build studies faster and smarter
Historically, ePRO study builds have been time-consuming, with complex studies often taking 16 weeks or more to complete. This is primarily due to the need to code applications from scratch for each new study and each operating system (i.e., web, Android, and iOS). This lack of reusability extends core build times and increases the risk of errors, leading to increased validation requirements.
Modern ePRO design focuses on reusability and configurability. Reusability is vital, not only for the efficiency gains during the current build, but it’s also important to think, “Can I use what I’m doing now for future builds?” Sponsor and CRO organizations often work across similar therapeutic areas. By creating a library of frequently used assessments, study teams can streamline the study build process and ensure full version control.
Although code libraries exist for traditional systems, many of them require significant manual intervention and validation. The shift from customization to configurability reduces touchpoints, minimizes risks, and accelerates the release of changes, both during the initial study build and later during protocol amendments. It also means web, iOS, or Android versions can be delivered with a simple ‘click’ rather than as a result of three independent builds. This simple interface and configurability of the build process means study teams have the choice to build studies themselves, use a third party, or of course, we can do it for them.
The incorporation of real-time feedback mechanisms and visualization represents a significant leap forward in the ePRO and eClinRO study build process. The ability to instantly preview an ePRO in any language on any device leads to faster feedback, allowing teams to quickly adapt and make changes as needed. Previews can also be viewed externally, opening up the opportunity for Institutional Review Boards (IRBs) or license holders to experience surveys themselves, rather than through static documentation.
When IRB documentation and screenshots are required, automating their creation represents an enormous time-saving innovation. Traditionally, these tasks demanded painstaking manual effort, consuming valuable hours and resources. Automation not only saves time and money, it also ensures precision and consistency in document generation.
Simplify study execution
One of the major challenges faced by study teams is dealing with protocol amendments. Traditionally, making mid-study updates has been laborious, time-consuming, and expensive. However, the shift toward configuration-based design changes the game. Updates can now be executed and visualized swiftly before user acceptance testing (UAT) and roll-out, complete with a full audit trail and version control.
Configurability extends to the method and location of assessments. Study teams can now offer multiple options for assessment access, whether it’s through site-owned devices, sponsor-provided devices, or participants’ own laptops, tablets, and smartphones. This flexibility enables in-person and remote assessment flows to be seamlessly integrated.
Enabling a ‘BYOD first’ approach means patients can opt to use their own device if they choose to. This provides a better experience as it enhances their familiarity and also reduces the support required, leaving sites to focus on more relevant activities. BYOD ensures greater patient compliance, as participants carry and maintain their devices, making it easier for them to remain engaged with the study.
Instant access to data
Traditional ePRO systems often silo data, making it challenging for study teams to access the data they need when they need it. These fragmented systems introduce multiple opportunities for human error, necessitating significant resources for data transfer, query management, and error resolution.
With a connected approach, data can be effortlessly transferred across the clinical ecosystem or to FTP servers. This eliminates the frustration of manual data transfer and means study teams can now access all questionnaire data, adherence data, and audit trail data in real time, right within the systems they are already using.
The development of modern ePRO and eClinRO systems provides the tools and processes study teams need to accelerate study build and meet go-live timelines. The ability to visualize assessments enables collaboration and feedback throughout the build process and accelerates the process of making adjustments, both pre-go-live and mid-study.
Additionally, automation of IRB and ethics committee package generation alleviates a significant cost and time burden. Through these systems teams can be confident that precise and reliable data is readily accessible throughout the entire study lifecycle, from initial design to the final closeout, enhancing data quality and integrity.
The future of ePRO and eClinRO is here, and it’s all about making research simple, efficient, and more effective.
Learn more about Veeva eCOA.