Datacubed Health’s CEO, Brett Kleger, Talks China Expansion and Innovations in Healthcare Tech

Datacubed Health, a leading global provider of innovative solutions for patient engagement and data collection in clinical trials, recently announced the official launch of its eClinical platform app in China.

This milestone achievement represents a significant step forward for Datacubed Health’s commitment to expanding its presence in the Chinese market.

As part of this strategic move, Datacubed Health has joined forces with AppInChina, a renowned leader in Android App Store publication, ensuring seamless deployment of the eClinical platform app in official.

Android stores across China and the Apple App Store. This partnership guarantees accessibility to a wide range of devices and ecosystems.

Brett Kleger, CEO of Datacubed Health, shares insights with Ayesha Rashid at Digital Daily News about the upcoming innovations, global expansions, and how Datacubed Health caters to the diverse healthcare tech needs with its new eClinical platform app.

Datacubed Health’s mission is to “advance access to healthcare for everyone, everywhere.” How do the intersection of behavioural science and technology contribute to a more rewarding clinical trial experience, and how does this align with your mission?

The integration of behavioural science and technology plays a crucial role in advancing Datacubed Health’s mission to “advance access to healthcare for everyone, everywhere.”

By embedding behavioural science principles into our technology, we are able to foster a safe and inclusive digital space that accommodates people of all backgrounds, including varied races, genders, ages, religions and socioeconomic statuses.

Behavioural science offers insights into how individuals make decisions, interact with technology, and engage in health-related behaviours.

By understanding these patterns, we can design our technology to be more user-friendly, accessible, and engaging, ensuring that participants in clinical trials have a rewarding experience. This not only aids in retention and compliance but also contributes to the generation of high-quality data, which is essential for the advancement of medical research and the development of new treatments and interventions.

Furthermore, the principles of behavioural science guide us in creating interventions and supports that are tailored to the unique needs and preferences of diverse populations. This ensures that our technology is not only accessible but also equitable, promoting inclusivity and reducing disparities in healthcare access and outcomes.

In aligning with our mission, the intersection of behavioural science and technology enables us to break down barriers to healthcare access, ensuring that clinical trials are more representative of the populations they aim to serve. This not only enhances the generalizability and validity of research findings but also contributes to the development of interventions that are effective across diverse groups, ultimately advancing healthcare access and outcomes for everyone, everywhere.

Data privacy is a critical concern in the healthcare industry. How does Datacubed Health ensure the protection of patient data and maintain a safe and secure environment while collecting and utilizing this data for clinical trials and research?

Datacubed Health places paramount importance on data privacy in the healthcare industry, recognizing the sensitive nature of patient data in clinical trials and research. To ensure the protection of this data and maintain a safe, secure environment, the organization has implemented several key measures:

Quality Management System: Datacubed Health has established a robust Quality Management System that includes comprehensive policies, procedures, and controls. This system is designed to comply with various data privacy regulations, including the strict standards of 21CFR11 and Good Clinical Practices (GCPs). The establishment of this system demonstrates a commitment to maintaining the highest standards of data privacy and security.

Privacy and Security by Design: The platform development at Datacubed Health is grounded in principles that prioritize data privacy, security, and integrity from the outset. This approach ensures that these critical aspects are not afterthoughts but are integrated into the very fabric of the platform’s architecture and functionality.

Adherence to Industry-Best Security Practices: To safeguard the data, Datacubed Health employs industry-best security practices. This includes the encryption of data both in-transit and at-rest, providing robust protection against unauthorized access or breaches. Additionally, the organization conducts regularly scheduled penetration testing to identify and address vulnerabilities proactively. Continual threat monitoring is also in place to detect and respond to potential security threats promptly.

Minimisation and Pseudonymization of Personal Data: Each project undertaken by Datacubed Health is designed with the goal of minimizing the personal data collected. Moreover, the data that is collected is pseudonymized, adding an additional layer of security and privacy. This approach helps in reducing the risk of personal data being linked back to an individual, thereby enhancing privacy protection.

Restricted and Managed Access: Access to the collected data is tightly controlled and managed through a role-based access system. This means that only authorized personnel with specific roles and responsibilities can access the data, and even then, only the data necessary for their role. This system of restricted access ensures that the data is not only secure but also used appropriately and ethically within the confines of the project’s goals.

The launch of Datacubed Health’s eClinical platform app in China is a significant milestone. Could you share some specific features or capabilities of the app that make it particularly valuable for clinical trials in the Chinese market?

Firstly, we have ensured operational compliance by forming a strategic partnership with AppInChina, a leading entity in the domain of Android App Stores publication in China. This collaboration has enabled us to deploy our mobile applications across official Android stores in the region, as well as on the Apple App Store. This extensive support for a wide range of devices and ecosystems ensures that our platform is accessible to a broader audience, facilitating seamless participation in clinical trials.

In addition to this, Datacubed has solidified its presence in China through the establishment of a legal entity, obtaining all the necessary commercial and legal licenses and certificates required to operate our platform efficiently. This includes permissions to publish websites, process and store data locally, and distribute software applications, ensuring that we are fully compliant with Chinese regulations and ready to serve the local market.

Moreover, we achieved full software compliance, with our platform for China being meticulously customized to leverage software solutions that are compatible with local requirements. Our local Quality Assurance (QA) teams have rigorously tested the platform to ensure that it meets the stringent network security requirements and restrictions imposed by Chinese authorities, guaranteeing both compliance and optimal performance.

On the infrastructure front, we established a fully compliant and fault-tolerant Software as a Service (SaaS) infrastructure within China, hosting the Datacubed China solution on AWS Beijing. This strategic decision ensures that our platform is robust, reliable, and ready to handle the demands of clinical trials in the region.

We understand the importance of transparency and are more than willing to provide a comprehensive list of all the licenses, certificates, and compliance measures we have undertaken to ensure our platform is ready and reliable for use in China. Our commitment to compliance, combined with our innovative features and local adaptability, makes Datacubed’s eClinical platform app an invaluable tool for conducting clinical trials in the Chinese market.

Could you elaborate on how Datacubed Health ensures software compliance with Chinese regulations? What specific measures and customizations have been implemented to align with local requirements and network security restrictions?

In addition to what has already been stated, we have the following licenses/certifications in China ensuring software compliance.

1 – B22 Domestic Multi-party Communication Service License.

2 – B25 Commercial ICP License.

3 – Software Copyright Certificate.

4 – ICP Filing, PSB Filing, Chinese Domain Name, and Locally hosted Landing Page.

5 – Trademark.

6 – Local Hosting.

7 – Multi-level Protection Scheme (MLPS) Filing.

8 – Apple App Store China Operational Compliance.

The eClinical platform app is designed to bridge the gap between global research initiatives and the Chinese healthcare landscape. Could you provide examples of how this app is facilitating international collaboration and improving clinical research efforts in China?

Datacubed Health’s eClinical platform app is meticulously designed to seamlessly bridge the gap between global research initiatives and the unique healthcare landscape of China, ensuring robust international collaboration and enhancing clinical research efforts in the region.

First and foremost, it is imperative to emphasise that we are not cutting corners in any aspect of our operations. Our approach is thorough and meticulous, aimed at not just meeting, but exceeding both country-specific and local requirements in China. By navigating through the complex legal and regulatory landscape in China, we ensure a stable, reliable, and secure experience for patients participating in clinical trials.

Our unwavering commitment to doing things the right way translates into a consistent and uninterrupted access to our app for patients in the region. They will not face sudden access issues or experience any blackout service, which is a common concern in regions with stringent internet regulations. This reliability ensures that there are minimal to no delays for sponsors, facilitating a smoother progression of clinical trials.

Furthermore, our platform provides a superior, seamless experience for patients. We understand the importance of user experience in clinical trials, and our app is designed to be intuitive, easy to navigate, and user-friendly. This not only enhances participant engagement but also contributes to better data quality, which is crucial for the success of any clinical trial.

In terms of privacy and compliance, we have left no stone unturned. Our platform ensures the utmost protection of participant data while meticulously adhering to Chinese regulations. We have implemented robust data protection measures and encryption protocols to safeguard patient information, ensuring that their privacy is protected at all times.

By facilitating these measures, our eClinical platform app stands as a beacon of reliability, compliance, and user-friendliness, fostering international collaboration and significantly improving clinical research efforts in China. Our approach ensures that global research initiatives can seamlessly integrate with the Chinese healthcare landscape, contributing to the advancement of medical science and the betterment of patient outcomes.

With the launch of the eClinical platform app, what specific opportunities or challenges do you anticipate for Datacubed Health in the Chinese market, and how does the company plan to address them?

With the introduction of the eClinical platform app in the Chinese market, Datacubed Health is poised to tap into a realm of new opportunities, while also being mindful of the unique challenges that this landscape presents.

One of the challenges we have identified pertains to the availability of eConsent on our platform. Due to the stringent privacy laws in China, eConsent is currently unavailable, posing a challenge for consenting patients in remote studies. Recognising this, Datacubed Health is proactively working to provide comprehensive guidance to study teams on how to navigate this aspect, ensuring that they are well-equipped to manage the consenting process effectively.

Despite this challenge, our partnership with AppInChina has positioned us to overcome many common barriers that typically hinder market entry and operation in China. This strategic collaboration enhances our credibility and acceptance among Chinese Institutional Review Boards (IRBs), making it more likely for our solutions to receive approval. This is a significant advantage, as solutions set up in alternative regions like Taiwan often face resistance and are less likely to be approved.

In terms of market adoption, while there might be a slower uptake from sponsors based in China, we have observed a growing interest from large global sponsors looking to streamline their studies with sites in China. These sponsors recognize the value and efficiency that our platform brings to clinical trials, and are keen on leveraging our technology to enhance their research efforts in the region.

To address these challenges and capitalize on the opportunities, Datacubed Health is committed to continuous innovation and adaptation of our platform to meet the specific needs of the Chinese market. We are investing in local partnerships, engaging with regulatory bodies, and fine-tuning our platform to ensure compliance, reliability, and user-friendliness. Our goal is to provide a seamless, efficient, and compliant clinical trial experience for all stakeholders involved, ultimately contributing to the advancement of healthcare and research in China.

How does Datacubed Health’s eClinical platform app contribute to the overall advancement of healthcare accessibility and patient engagement, and what role does it play in the evolving landscape of healthcare technology?

Datacubed Health’s eClinical platform app significantly contributes to the advancement of healthcare accessibility and patient engagement, marking a pivotal role in the evolving landscape of healthcare technology. By bringing the app directly into patients’ homes, it enables participants to engage in clinical trials from any location, thereby greatly enhancing accessibility. This approach is particularly beneficial for those who might face geographical, logistical, or mobility challenges in attending clinical sites.

Furthermore, Datacubed Health has created a safe and inclusive digital space within the app. By being mindful and accommodating of age, race, gender, socioeconomic status the app ensures that a diverse range of participants can access and engage with clinical trials comfortably and confidently. This inclusivity is crucial in obtaining a broad, representative spectrum of data, which is essential for the efficacy and reliability of clinical research.

Patient engagement is another cornerstone of this platform. The app maintains continuous interaction with patients throughout the study, bridging the gaps often left by clinical sites. Clinical research studies, which can span several years, typically have periods where patients are not in direct contact with the study sites. During these intervals, Datacubed Health’s app plays a crucial role by providing ongoing content and study updates. This consistent engagement keeps patients informed, motivated, and connected to the study, which can significantly improve adherence and the quality of data collected.

Overall, the eClinical platform app from Datacubed Health represents a forward-thinking integration of technology and healthcare. By improving accessibility, promoting inclusivity, and ensuring continuous patient engagement, the app not only enhances the experience and effectiveness of clinical trials but also signals a broader shift towards a more patient-centric approach in healthcare technology.

What innovations or enhancements can we expect from Datacubed Health soon, both in terms of global expansion in Australia or around the world, and in addressing the specific needs of the global market?

Datacubed Health is actively focusing on global expansion and technological innovations to better serve the diverse needs of the global market. A key aspect of this strategy includes prioritizing expansion into Australia and the rest of the Asia Pacific region. This move is part of our broader vision to grow and serve a wider audience, bringing our advanced solutions to new markets and demographics.

In terms of technological advancements, Datacubed Health is placing a significant emphasis on enhancing efficiencies for sponsors and Contract Research Organizations (CROs). By harnessing the power of Generative AI, we are pioneering new ways to streamline processes and make data handling more efficient. However, it’s crucial to note that while we are excited about the potential of AI, we are equally committed to exploring this domain safely and responsibly, ensuring that our innovations align with ethical standards and global regulations.

Another area of focus is reducing translation timelines. As we expand our global footprint, it becomes increasingly important to ensure that our eCOA assessments are accessible and relevant to diverse patient populations. To this end, we are intensifying our efforts to shorten the translation timelines. This enhancement not only improves accessibility but also ensures that our assessments are culturally sensitive and accurately reflect the nuances of different regions. By doing so, we aim to provide more inclusive and reliable tools for patient assessment across various global markets while reducing study timelines for Sponsors.

Furthermore, we are continuously evolving our app to ensure it remains a digital safe space for all users. Recognizing the importance of retaining diverse patient populations in research studies, our app is designed to be inclusive, user-friendly, and sensitive to the varying needs of different communities. This commitment to diversity and inclusion is not just a part of our business ethos; it’s also a driving force behind our technological innovations and market strategies.