The patient experience defines success in clinical trials as landscapes continue to change. At OnTracka, mapping the journey of a patient forms one link in the chain of processes, holding within its core two important pillars: quality of data capture and the effectiveness in the display of data. This blog will walk you through parts of our process to demonstrate how we ensure that at the heart of everything lies patient-centricity.
1. The Foundation
We start by carrying out our specialist patient mapping exercise for each research project. It is a very important first step since everything follows from it. We believe that unless the needs, challenges, and expectations of all stakeholders are duly understood, no effective solutions can be designed.
It is a collaboration involving researchers, healthcare providers, and even regulatory bodies where required. This active collaboration helps to gather a complete picture of the patient experience and identify key touch and pain points that will from part of the architecture for the study and or project.
2. Breaking down the protocol
Once the mapping exercise is performed, we delve into the clinical trial protocol. Internally, we conduct exercises in which we actually break down the protocol into components that can be more easily digested, and where we can verify each component for regulatory requirements versus our specialist patient experience knowledge.
Design rules are applied rigorously. We make use of a set of design principles, which help us fracture the protocol to ensure quality. This includes not just looking at possible pitfalls, especially in data collection, but also showing how those pitfalls can be avoided. The objective is always about leveraging our growing knowledge from running multiple world-first trials to ensure the credibility of the study while making it as seamless and hassle-free as possible for patients and researchers.
3. Prototyping for Possible Issues
After deconstructing the protocol, we go into design and prototyping. This phase is about anticipating problems before they occur in the study. With the novelty of virtual/remote clinical trials, often, the expertise we have in obtaining high-retention is brought into this process to create prototypes of the User Interface (UI) and User Experience (UX) to test and iterate on the technology that will be used for this study.
We research and experiment. For example, where a study requires the implementation of new functionalities, like live Sp02 monitoring through a smart watch, we investigate all the technological solutions proposed. Prototyping enables us to detect problems at a very early stage, which proves beneficial for ensuring that the final product will be robust, reliable, and user-friendly.
4. Privacy and Security
At OnTracka, we are deeply convinced that the success of clinical trials depends on innovative solutions combined with a patient-centric design, all while maintaining the highest standards regarding privacy and data security. Security in regard to patient data is one of the key priorities in our process, showing how much we care about ethical research practices.
Data Anonymisation and Informed Consent: Before embarking on their journey within a clinical trial, our SOPs drive the rigour placed around data collection, data processing, data storage, and data sharing.
Security Infrastructure: The backend infrastructure is designed with a multi-layered security approach. This will comprise encryption protocols for data at rest and in transit, secure user authentication methods, and regular security audits. We are compliant with global regulations concerning data protection, such as GDPR and HIPAA, therefore our practices are aligned with international standards.
Global Accessibility and Efficient Flow of Data: The servers are hosted by OnTracka to support patients and researchers all over the world. Cloud-based solutions will be implemented to make sure that data flows at an efficient rate, irrespective of geographical locations. Scalable, secure cloud hosting solutions are employed in ensuring seamless access to our services, ensuring thereby that our technology supports the demands of global clinical trials.
5. Technology Backbone
Hence, our SaaS model is flexible and elastic software, suitable for different clinical trials. That gives us a great ability to offer wide functionalities, from data collection and analysis through communication to patient management in one platform.
Admin Portal and Integration with a Mobile App: We provide two important technological innovations to both the researcher-admin portal and participants in general, a mobile app, and a web app. The admin portal will enable researchers to view study progress, understand patient interaction, and subsequently enable data analysis. Our industry-leading technology enables the detection of challenges at the earliest stage to support partner CROs and researchers to keep participants on track and be alerted to any issues, should they arise. On the participant side, the mobile application shall enable seamless and intuitive completion of study tasks, reporting of any adverse events, logging of data, and communication with researchers.
Interconnected Systems for Seamless Operations: A sound back-end system allows for smooth integration of these platforms; this helps in the easy flow of information between a researcher and a participant. This integrated system allows messaging, video calls, and real-time updates, hence keeping all the stakeholders informed and involved.
6. Collaboration
Collaboration on OnTracka is ongoing. We make initial designs and prototypes, then collaborate with researchers on a QA process. Sharing thoughts and designs enables us to take in feedback and insights that would be really helpful in improving study features.
Researchers and healthcare professionals provide valuable feedback. In this way, the design will meet the practical requirements of those carrying out the study as well as align with all regulatory and ethical expectations. We ensure that a seamless connection is established between the admin portal, which the researchers will use, and the patients through the mobile/ web app in order to facilitate communication and changes throughout the study.
7. Building and Testing
Once the designs have been refined and approved, we move into the building phase. This comprises the development of the technology which will support this study. But our commitment to quality does not stop here. Internal QA testing is being extensively carried out-we simulate various scenarios to see where a problem can occur, and then we fix it.
It is comprehensive explanatory testing. Our team will put it through hard testing so that it passes the highest standards in production. Any issues, however, that are unearthed through this intensive process will immediately be amended, and then the product will again be tested regarding its reliability and functionality.
6. Researcher QA and Final Adjustments
After internal QA, the product is shared with researchers in a development environment where they have the opportunity to execute further QA testing. Such collaboration ensures the product meets the specific needs of the study and caters to the unique needs of the research team.
Feedback loops are essential. We work with the researchers to make whatever adjustments may be necessary so that the final product is polished and ready for use.
7. Onboarding and Training
Having completed the technology, we turn our focus to onboarding participants and research administrators to the study. We would prepare comprehensive onboarding material like demo video and booklets containing information regarding the use of the app and the process of the study in specific detail.
The materials prepared are user-friendly for all users, and the study is designed such that it is readily understandable by and can be easily engaged in by all users, regardless of their level of technical proficiency.
8. Study Implementation
With all this, the study becomes current. The patients go about the protocol on the mobile app or on certain study the web application while researchers track the progress on the admin portal. Our platform is designed to make participation as easy and simple as possible, keeping the patient burden low and improving compliance.
9. Data Review and Analysis
As the study goes on, our support continues, with ongoing data analysis and review through an admin portal. Through this portal, it is possible for researchers to view participant data in real time and ensure their progress is on course to make informed decisions.
Thanks to our technology, it's possible for researchers to derive a lot of meaningful insights from the study that may help them make proper understanding of any trends, making the necessary adjustments, thereby ensuring the study is going to be a success.
Conclusion
At OnTracka, our process is committed to being patient-centric, assured of quality, and collaborative. We understand that each clinical trial is unique, and this uniqueness is the reason we are always adapting our approach toward the particular needs of every study. From patient mapping and protocol breakdown, through prototyping, and to QA, a comprehensive process is ensured for delivering technology solutions that would enhance the patient experience and drive success in clinical research. Where the level of the study's complexity, the features needed, and other factors vary, so does the time to develop and deploy these solutions, but one thing that remains constant is our commitment to excellence and data security.
We are rebuilding the clinical trial experience with an innovative approach: more efficient, patient-friendly, and effective, while maintaining high standards of privacy and security. That's how we make sure every trial taking place on OnTracka counts toward better healthcare outcomes.
If you want to reach out to see the difference OnTracka can make to your next study, request a demo or speak to one of our team members
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