How the drive to maximize valuable data while minimizing patient and study team burden resulted in a unique data collection and management platform.

Patient engagement is a delicate aspect within clinical research – especially in the current age of decentralized clinical trials (DTCs), hybrid, and mix-model trials. Balancing the need to gather as much comprehensive information as possible from patients while also keeping the process as simple and straightforward as possible is a constant challenge.

Clinical trials are also increasing in complexity and scale, with sites often supporting multiple studies simultaneously. Innovations and solutions designed to improve or enrich the protocol sometimes inadvertently create an operational nightmare for the study team.

These realities underpin Cognivia’s approach to capturing and managing the patient traits data that serves as the basis for the Compl-AI and Placebell solutions. Our goal is always to maximize valuable data while minimizing the burden on both patient and study team, and this has guided development of our unique unik-me platform.

What is Unik-me?

Both Cognivia’s Compl-AI and Placebell rely on input from patients, completed through an e-questionnaire at the beginning of the study.

Originally, the questionnaires were administered through a traditional EDC platform, but we quickly discovered it was an imperfect fit from a usability perspective. In response, Cognivia developed the proprietary unik-me platform based heavily on feedback from patients, study teams, and internal stakeholders.

Unik-me is sophisticated technology behind the scenes but offers an easy-to-use interface for both clinical site staff and participants. This user-friendly design helps to minimize the burden on users while maximizing the quality and completeness of the data collected.

Key Features and Benefits of the unik-me Platform

Today, the key features and benefits of the unik-me platform include:

• An easy-to-use interface for clinical site staff and sponsors
• DCT- and hybrid-ready “on any device” questionnaires for patients
• 30+ language translations to accommodate diverse patient populations (and growing)
• Custom reporting
• Automated generation of study lifecycle documentation

A More Efficient Clinical Trial

Unik-me is central to the Placebell and Compl-AI solutions, and its integration into our processes allows us to operate with greater efficiency. By tailoring unik-me to meet our specific needs and those of our customers, we can streamline operations, reduce processing times, and ensure compliance with regulatory requirements. 

For instance, we can export data in specific formats to expedite the computation of the Placebell covariate, significantly reducing processing time. Additionally, to facilitate the production of documents required by regulators, we have automated the generation of data management documentation within unik-me. This automation streamlines our workflow, ensuring that all necessary documentation is accurate and readily available, thus supporting our compliance efforts.

We are also able to develop features with the future in mind. One of the standout features of the unik-me platform is its ability to provide Compl-AI recommendations as soon as the required questionnaires are completed. This real-time feedback is crucial for maintaining high levels of patient engagement and compliance throughout the study.

Using Unik-me

One of the key strengths of the unik-me platform is its ability to balance simplicity for the end-user with sophisticated technology behind the scenes. This balance is crucial for ensuring both user satisfaction and the effectiveness of the platform.

For Participants

From the participant’s perspective, using unik-me is as simple as completing an online questionnaire. The interface is intuitive and user-friendly, designed to minimize any burden on the participant. This simplicity encourages higher completion rates and more accurate data collection.

Behind the Scenes

Behind this straightforward interface lies a complex and advanced system. As participants respond to the questionnaire, their answers are evaluated to assess their risk of non-compliance with the treatment or protocol. This evaluation is powered by sophisticated models that analyze the data and generate recommendations based on the output of these models.

For Study Coordinators

For study coordinators, the system presents these complex analyses as simple suggestions and recommendations. This user-friendly presentation allows coordinators to quickly understand and act on the insights provided, without needing to dive into the underlying technical complexities.

Development Details

At Cognivia, our highly skilled team leverages the most efficient methodologies and techniques to ensure high-quality and timely delivery of our solutions. The development of the unik-me platform was driven by several key technical aspects and methodologies described here below, and these underpin our continual development efforts.

Development Methodologies

We employ an agile methodology to adapt quickly to changes and continuously improve our processes. Additionally, we utilize DevOps practices and Continuous Integration (CI) via automated pipelines in GitLab, our code management platform. These pipelines are crucial for verifying code quality, executing tests, performing security verifications and deploying review environments for internal testing of new functionalities.

System Architecture

The unik-me platform is built on a robust and secure architecture:

• Back-end: Developed using Django, the back-end is responsible for data protection, access management, and data integrity verification. The back-end is also in charged of applying the Compl-AI models to the data to determine the Compl-AI recommendations.
• Front-end: Built with Angular, the front-end handles data collection, including responses to questionnaires and participant information.
• Internal Tools: We use various internal tools to monitor the system and generate reports, ensuring smooth and efficient operations.

Data Management

Compliance with regulatory requirements is an integral part to our design. The unik-me platform adheres to 21 CFR Part 11 and GDPR. To increase even more the security, we conduct security scans on each code change and permormed annual penetration testing to identify and mitigate potential vulnerabilities.

Validation and Testing

Our validation and testing processes are rigorous and follow industry standards. In essence, our Standard Operating Procedures align with GAMP5 second edition. And to futher facilitate the validation of unik-me, we use MatrixALM by Matrix Requirements to record validation design items, review them, perform risk analysis, and conduct tests.

Continuous Improvement

We are committed to continuous improvement. After each release, we conduct thorough reviews to identify what went well and what areas need further attention. This iterative process helps us refine our methodologies and enhance our system’s performance and compliance continuously.

Platform Evolution

The unik-me platform stands out due to its robustness, flexibility, and the expertise behind its development and exemplifies Cognivia’s commitment to innovation, efficiency, and user-centric design. 

By seamlessly integrating advanced technology with an intuitive user interface, unik-me not only simplifies the data collection process but also enhances the overall effectiveness of clinical trials. Our continuous efforts in process optimization, compliance, and customization ensure that we meet the highest standards of quality and reliability. As we look to the future, we remain dedicated to evolving our platform to meet the ever-changing needs of the clinical research landscape, ultimately driving better outcomes for patients and study teams alike.