WeTrials

Clinical trials are the cornerstone of the drug development process, and part of their success is contingent on enrolling enough participants within a specified timeframe. Nevertheless, timely patient recruitment and retention is a critical bottleneck leading to delays or termination of trials, increased costs, and missed opportunities for medical breakthroughs. We hypothesize that low patient awareness and understanding of clinical trials, and the process associated with participating in them, is a major factor limiting patient recruitment and retention.

To better understand the trajectory for an individual once he or she is diagnosed with a rare or serious condition, we have conducted multiple rounds of interviews with patients and care partners who have experienced glioblastoma. The path typically begins with a surge of anxiety and stress associated with the one-way flow of medical information from healthcare professionals to the patient and their care partners. Additional tests and interventions may be necessary, and clinical trials may not be appropriate. The specific hospital the patient is at may not offer any clinical trials and the medical team may not be aware of any. Among individuals who may seek out more information online, the range of clinical trial options may be overwhelming, the language is unnecessarily complex, and additional unknowns such as cost, and time burden are usually not addressed. An AI-based platform may help match them to a clinical trial but questions regarding study specifics and support surrounding participation remain. 

The impact of these recruitment challenges is significant and destructive. Every day a clinical trial is delayed, it results in a significant waste of resources for patients, academia, and society. The cumulative long-term consequences are also staggering. In glioblastoma, the most common and fatal adult brain cancer, only 5% of potentially eligible individuals aware enroll in clinical trials; consequently, survival in this disease has not changed in nearly 2 decades.

WeTrials will solve these bottlenecks and problems by developing an online platform with the objective to democratize the clinical trial process by taking a patient-centric approach. 

The innovation lies in the ability of WeTrials to combine AI with the human element to empower patients and their families to make informed decisions. The platform will provide personalized, just-in-time recommendations matched to the patients’ current diagnosis and disease journey. Personalized educational resources offered by WeTrials will also demystify and destigmatize the clinical trial process. The AI platform will summarize the latest research in an easy-to-read manner to enhance patient understanding. Furthermore, the platform will also contain curated additional information to help rare disease patients throughout their journey, including financial, logistical, physical, and psychological support. Immersion within a community and connection with other patients and care partners who have had similar experiences will further support patients through their disease and clinical trial journey.

WeTrials will also serve as a balanced, professional, and holistic resource center for other key stakeholders as well. Healthcare professionals will be able to easily map out appropriate clinical trials for their patients and facilitate their engagement with research while saving valuable time.

We propose a revolutionary solution to tackle low patient enrollment and awareness in clinical trials for rare diseases. WeTrials leverages a sophisticated algorithm that brings forth a harmonious combination between AI technology and the communitarian, grassroots, and personal needs of users, to simplify, evolve, and proactively improve the critical components of the clinical trial process. By constantly learning more about the patient, the core innovation of WeTrials lies in its ability to provide personalized recommendations and resources to patients that are appropriate to the patients’ current diagnosis and disease journey. Through an intuitive and easy-to-use interface, patients will be able to navigate the platform, gaining access to relevant clinical trial information that is specifically tailored to their needs. The platform will present information in an easily understandable manner, demystifying the currently-hermetic semantics of the clinical trial process and empowering patients to make active and informed decisions about their participation.

In addition to personalized recommendations, WeTrials will provide thorough, comprehensive, and holistic summaries of the latest research relevant to rare diseases, again by demystifying the sometimes-hermetic and impenetrable semantics of the medical research ecosystem. This feature will bridge the information gap between patients and researchers, allowing them to stay up-to-date with advancements in the medical field pertaining to their condition. By presenting research findings in a digestible format, WeTrials will foster patient education, awareness, and engagement, eliciting active participation of patients in their healthcare journey.

Moreover, WeTrials aims to be a 360-degree ecosystem for patients. This means that through our web tool, we will create a supportive community where patients, caregivers, and healthcare professionals can connect and share experiences. This community-building aspect will provide a platform for individuals to seek emotional support, exchange knowledge, and learn from others who have gone through similar experiences. Users can also glean detailed information about the site or investigators running the clinical trial, along with ratings by past participants, which can assist in choosing between multiple sites offering the same trial. WeTrials will also facilitate a personal connection between the investigators and patients by co-creating written and digital media content centered on the trial. 

Another aspect of our 360-degree work with our web platform consists of its development as a valuable resource for healthcare professionals and pharmaceutical companies. The former will have access to a centralized platform where they can easily identify relevant clinical trials for their patients, saving time and valuable resources in the referral process, while the latter will be able to utilize WeTrials to map out suitable centers and institutions for collaboration and engagement.

WeTrials aligns completely with the 2023 Horizon Prize objectives by focusing on technology-based solutions that decrease carbon footprints in the rare disease healthcare space while focusing on patient priorities. By providing an online platform, WeTrials significantly reduces the need for duplicative travel and testing for patients and caregivers, thus minimizing carbon emissions. Additionally, the platform's digital nature reduces the dependence on single-use products, unnecessary plastics, and medical/hazardous waste throughout the research and manufacturing processes.

In preparation for the creation of the WeTrials solution, we have conducted several hours of stakeholder interviews. Based on knowledge gleaned from this, WeTrials will serve a plethora of stakeholders while proactively changing patients’ lives for the better.

• Primary Target Cohort – Patients and their caregivers/ families: Our solution puts patients and their caregivers at the center of clinical research through the simplification of the process of finding and enrolling in clinical trials. We address innovatively the lack of awareness and understanding of clinical trials while destigmatizing them. Our team of experts will work on an algorithm that will potentially increase the likelihood of finding suitable clinical trials that align with the patients’ medical history and health status. Our 360-degree community-building approach will also ensure that patients and their families have access to institution-specific and clinical trial-specific resources and information, along with emotional support, knowledge sharing, and a sense of belonging. 
• Secondary Target Cohort – Healthcare Providers: WeTrials will make operational capacities easier for healthcare providers, including oncologists, surgeons, and family doctors, helping them identify relevant clinical trials for their patients. By simplifying the process of finding appropriate trials, healthcare providers will save time and resources that would otherwise be spent on referral processes, manual searches, and word-of-mouth, all the while fulfilling their duties as patient advocates. The platform will offer highly efficient patient-provider communication, empowering healthcare providers to discuss clinical trial options with their patients based on reliable information provided by WeTrials. This enhances the quality of care and duty of healthcare providers while maximizing their positive impact on improving patient outcomes. Furthermore, WeTrials aims to make clinical trials more visible, understandable, and accessible to patients. The platform will present trial information in a user-friendly format, providing explanations and details to help patients make informed decisions. By eliminating barriers and streamlining the enrollment process, our goal is ensuring that patients have an easier path to enrollment in clinical trials, maximizing their access opportunities.
• Secondary Target Cohort – Pharmaceutical Companies: WeTrials will offer significant benefits to pharmaceutical companies. Our holistic platform will generate a large and diverse pool of potential participants and will empower them toward a streamlined trial site selection process while improving operational efficiency and reducing costs. This will allow them to not only focus more resources on R&D, but also to minimize the carbon footprint, unnecessary waste materials, and non-biodegradables.
• Tertiary Target Cohort – Society and the healthcare industry/ ecosystem in general: The proactive and positive impact of WeTrials will extend beyond individual patients, healthcare providers, and pharmaceutical companies. By increasing awareness and participation in clinical trials, the platform will reduce the stigma associated with research involvement. This will foster a culture of patient engagement and empowers individuals to actively contribute to medical advancements. Additionally, by reducing the reliance on duplicative travel, and single-use products, and optimizing transportation efficiency, WeTrials will actively contribute to the reduction of carbon footprints in the rare disease healthcare ecosystem, aligning with MIT Solve and United Nations’ sustainability goals.

Our team of experts has a strong edge in delivering the WeTrials solution while actively addressing The Horizon Prize goals. There are several factors that contribute to this end:

• Expertise in rare disease healthcare: Our team comprises of professionals with diverse backgrounds in healthcare, patient advocacy, and technology development. We have a deep understanding of the unique challenges faced by patients and their families, as well as the complex landscape of rare diseases and clinical research. As a representative example, one of our team members, Dr. Alireza Mansouri, is a clinical and research expert on brain tumors, early phase surgical trials in glioblastoma, and liquid biopsy studies for malignant brain tumors. Furthermore, our team consists of seasoned large-scale program managers and coordinators, thus giving us an edge in both technical field-related expertise and broader program delivery.
• Technological innovation: We have a track record of developing user-friendly platforms and tools out of very complex and technical processes. We have been highly successful in the development of such platforms in the past, and our algorithmic capabilities, data analysis, and user experience design are cutting-edge. In fact, WeTrials CEO Romeo De Leon has experience in developing new innovative products from idea to launch. This includes the entire product lifecycle of designing, developing, testing, and releasing. This also involves roadmap development and the design of business strategies to monetize and accelerate growth. Mr. De Leon has a successful track record of building and leading cross-functional teams from Product and Development to Marketing, Sales, and Alliances. This experience in both the clinical, technical, and capacity-building dimensions, gives us an edge in the healthcare innovation sector.
• Patient-centered humanistic approach: We firmly believe in putting patients and their families at the center of focus, and are committed to patient empowerment through a deeply humanistic approach. We have a thorough understanding of the emotional impact of rare diseases on individuals and their loved ones, and we strive to create a supportive community that provides access, resources, and information to facilitate the process of trial selection and enrollment for them to ultimately reduce the cost and time burden for patients and their care partners.
• Stakeholder network: We are working continuously to establish strong partnerships and strategic engagements with patient advocacy groups, healthcare providers, and pharmaceutical companies. These collaborations will enable us to gather insights, validate our solutions, and ensure that WeTrials meets the needs of all stakeholders.

The WeTrials platform is a prototype rather than a concept because we have progressed beyond the initial idea stage and have successfully kicked off with the development of a functional version of our online platform. While we are not yet serving users, we have successfully developed detailed designs, with our prototyping process going through extensive user feedback and interviews. As part of the design process, we have developed a user-friendly interface. In addition, we have developed our AI code proof of concept, which currently satisfies metrics for both accuracy and understandability.

Moreover, we have already established partnerships, collaborations, and engagements with various stakeholders, such as brain tumor advocacy groups, patient partners, and external business and pharmaceutical advisors, to ensure the relevance and applicability of our platform to all stakeholders. These partnerships demonstrate the viability of our solution.

We are applying to the 2023 Horizon Prize because it represents a unique opportunity to further our mission of putting patients and their families at the center of clinical trials while addressing the urgent need to decrease carbon footprints in the rare disease healthcare space. This Prize aligns perfectly with our vision, ambition, and goals. Winning it would enable us to accelerate the development and implementation of our WeTrials solution while addressing current bottlenecks.

• Validation: Being awarded the 2023 Horizon Prize would provide significant validation and recognition for our team of experts. It would demonstrate that our approach and efforts in revolutionizing and shifting the clinical trial landscape are supported by esteemed organizations such as MIT Solve. This would help us scale up while building trust with patients, who are at the center of our humanistic approach.
• Funding to drive impact: The $150,000 prize funding would be instrumental in fueling the development and expansion of WeTrials, while addressing bottlenecks associated with the early stage of all such innovative solutions. It would enable us to invest in the necessary technology infrastructure, algorithm refinement, user experience optimization, and community-building initiatives while continuing to deliver a robust and user-friendly platform that truly meets the needs of rare disease patients and maximizes the positive impact on their lives.
• Collaboration and network expansion: The 2023 Horizon Prize offers a unique opportunity to connect with other like-minded innovators, experts, and researchers. MIT Solve’s network and events would provide a highly-valuable entry point into collaboration and knowledge sharing, enabling us to learn from other participants, share best practices, and form partnerships. MIT Solve successful teams of innovators who have in the past brought about so much good into the world through tracks like Equitable Health Systems, The Care Economy, Health Security, Digital Inclusion, Frontlines of Health, etc., would enhance the scalability and impact of our solution while empowering a better future for the medical ecosystem.
• Matching global priorities: The 2023 Horizon Prize focuses on reducing waste, increasing the impact of research, decreasing environmental costs, and development investments. We fully align and are committed to these global priorities. At WeTrials, we believe that our game-changing web tool solution addresses these priorities by streamlining clinical trial processes and reducing unnecessary resource consumption. We work proactively, through large-scale initiatives like WeTrials, to effectively reduce waste, minimize patient time spent traveling, the carbon footprint, and wasteful clinical resources (financial or otherwise), while ultimately maximizing the efficiency of societal resources. 

Our Team Lead, Romeo De Leon, will leverage his many years of strategic engagement experience with our deeply connected grassroots community and the healthcare ecosystems related to this project. His extensive entrepreneurial experience in the startup and growth ecosystems has provided him with opportunities to engage with various stakeholders at both the private, public, and community levels.

Mr. De Leon recognizes the vital importance of building strong relationships and fostering collaboration within the community to drive meaningful change. He actively participates in events, conferences, and forums related to the medical field, medical R&D, and the latest from rare disease research, while engaging strategically with fellow scientists.

Moreover, he is building a team revolving around a harmonious combination of tech innovation, medical expertise, scientific discovery, community engagement, and program management, to ensure that we can proactively empower communities.

Mr. De Leon’s connections and involvement in the community go beyond business interests, toward building something humanistic, empowering, and life-affirming for individuals affected by rare diseases. He and his team strive to create a supportive and inclusive environment, while actively interacting with the community's feedback, suggestions, and challenges, toward making their voices heard in the decision-making process.

Our WeTrials solution is innovative and sustainable in several key ways:

• Innovative algorithm-driven matching: We leverage a sophisticated algorithm that matches rare disease patients with clinical trials based on a multitude of patient-related criteria. This innovative approach streamlines the trial selection process, saving patients and their families significant time and effort. By combining AI with the best features of a humanistic approach that leverages deep social understanding, human relations, empowerment, communities, and strategic networking, we will eliminate the need for redundant, inefficient, long, and slow manual searching and reduce the chances of missing out on potential trial opportunities.
• Personalized recommendations and resources: WeTrials goes beyond basic trial matching by providing patients with personalized recommendations and resources to help them make informed decisions about their participation. Our personalized approach empowers patients and their families to navigate the complex landscape of clinical trials and make positive, well-informed choices. By demystifying the clinical trial process and offering tailored support, WeTrials promotes continuous and sustained patient engagement beyond the project timeline.
• “Democratization” of clinical trials: WeTrials will be openly accessible to patients and care partners, as a core philosophy of our organization. By breaking down the glass ceiling of hermetic technical semantics, it will provide easy access to understandable information. Patients will be able to sustainably take charge of their health and explore trial alternatives independently, which will lead to empowerment and promotion of inclusivity in the medical research process.
• Reduction of resource waste: Our web tool solution will contribute to the sustainability of the rare disease healthcare ecosystem by reducing resource waste associated with clinical trials. No more faxing or mailing medical records or unnecessary travel to trial sites only to be told one is not a candidate. By streamlining the trial selection process and connecting patients with relevant trials more efficiently, we will minimize the time, cost, and resources expended on unnecessary travel and testing. Furthermore, by helping patients understand the nuance of the clinical trial they are enrolling in, we reduce risks of premature termination of such trials. This will in turn lead to reduced waste, time, and energy, costs, and other similar variables that serve as the entry point into kicking off with trial work, The removal of duplicative efforts will eventually reduce the overall carbon footprint of the diagnostic and therapeutic journey. Moreover, by optimizing patient enrollment and retention, we will help prevent delays, significantly reducing the waste of resources for patients, academia, and society.. Furthermore, our longer term vision is to facilitate Decentralized Clinical Trials (DCT), the future of clinical trial conduct in our opinion. Through DCTs, we will be able to encourage as many tele-visits as possible while having imaging and lab tests done close to home, rather than travel to the study site, thus reducing travel time, the carbon footprint, and negative environmental impacts, while making trials more accessible.

Our impact goals are centered around transforming the landscape of rare disease clinical trials while driving positive outcomes for patients, like-minded public and private agencies, and the environment. 

Next Year:

Increase patient awareness and enrollment: Our primary short-term goal is to significantly increase patient awareness about clinical trials while improving enrollment and retention rates. To this end, we will build a comprehensive and holistic Communications Strategy, while focusing our efforts on marketing and outreach efforts. We will engage with patient advocacy groups, healthcare organizations, and grassroots communities, to raise awareness about the WeTrials platform. We will also implement educational campaigns to address the stigma associated with clinical trials.

Scale trial database and engagement: We aim to expand and scale our trial database by forging partnerships with research institutions, pharmaceutical companies, advocacy groups, and other like-minded stakeholders within the medical research ecosystem. These collaborations will provide us access to a broader range of trials and ensure that our web tool offers a comprehensive and up-to-date repository of opportunities. We will engage in proactive outreach to encourage trial sponsors to list their trials on our platform while exploring partnerships with patient registries and healthcare providers to ensure seamless data integration.

Foster a supportive patient community: We will focus on nurturing a supportive and empowering patient community within our platform. We will develop interactive features such as discussion forums, patient testimonials, and support groups, to create a sense of belonging while encouraging knowledge-sharing among users.

Next Five Years:

Facilitate nationwide access to clinical trials: Over the next five years, we aim to expand our reach and impact to a substantial number of communities in the United States and Canada. We will focus on forging partnerships with local, state, and federal stakeholders, patient organizations, and regulatory bodies to ensure that WeTrials becomes an important resource for patients nationwide. Given the diverse needs pertaining to each local community, we will start with rare diseases and then in turn scale up and leverage our ever-growing network of partners to tackle additional diagnoses in a sensible manner. This will maintain our solution’s agility while ensuring steady growth. Our long-term goal is to introduce our work and empower our cohort target groups beyond the confines of the US and Canada, expanding worldwide.

Policy and practices: We aim to have a broader impact on the rare disease healthcare space by actively engaging with policymakers and industry stakeholders. We will leverage our growing user base and data insights to advocate for patient-centric policies, streamlined regulatory processes, and sustainable practices in clinical trials. 

M&E and communicating environmental impact: As sustainability is a core value of our solution, we will implement rigorous measurement, monitoring, and reporting to assess the environmental impact of WeTrials. We will collaborate with environmental experts to develop KPIs and benchmarks for carbon emissions, resource optimization, and waste reduction. We will disseminate yearly sustainability reports to transparently communicate our progress and hold ourselves accountable to our environmental targets.

Patient Awareness, Enrollment, and Retention:

• Number of website visits and unique users: We will track the number of visits to the WeTrials platform and the growth of our user base. This will indicate the level of awareness and engagement among patients and their families.
• Enrollment rates: We will measure the number of patients who successfully enroll in clinical trials through our platform, compared to currently established nationwide (both US and Canada) benchmarks. Part of our enrollment metrics will be diversity and inclusion, to satisfy our vision of “democratizing” clinical trials and making them widely accessible to underserved communities, minorities, and intersectional communities. 
• Retention rates: We will measure the length of patient engagement against currently-established benchmarks, evaluating areas of increased and decreased retention rates respectively. Furthermore, a key element that will inform our analysis will be the measurement of time to reach recruitment targets per trial, as compared to currently established benchmarks in the clinical trials ecosystem of the US and Canada respectively. 

Trial Database and Engagement:

• Number of listed trials: We will monitor the growth of our trial database, measuring the number of clinical trials listed on the platform. This will indicate the extent of our partnerships with research institutions, pharmaceutical companies, and trial sponsors. These numbers will be charted against the baseline in our yearly reports.
• Diversity of trial options: We will assess the range of therapeutic areas and geographic locations covered by the listed trials. This metric will help us evaluate the inclusivity and accessibility of our trial database.

Supportive Patient Community:

• User engagement: We will measure user engagement within the WeTrials platform, including posts, the number of community interactions, comments engagement, and a comprehensive system of ratings and reviews.
• User satisfaction surveys: We will conduct periodic surveys to gather feedback from users about their experience with the platform.

Expanded Access:

• Expansion to new regions: We will track the growth of our user base in different regions and communities of North America and Canada.
• Partnerships with local, state, and federal organizations: We will measure the number and quality of partnerships established with local, state, and federal research institutions, patient advocacy groups, and regulatory/ policy bodies.

Environmental Sustainability:

• Carbon emissions reduction: We will establish baseline measurements for carbon emissions generated through clinical trial participation, and Decentralized Clinical Trials (DCT), and track the reduction achieved through the use of our platform. This will involve collaborating with environmental experts.

To collect and collate this data, we will combine analytics tools, surveys (both qualitative and quantitative), user feedback, and partnerships with R&D institutions. We will employ data analytics to generate insights, track trends, and measure progress against KPIs. Yearly reporting will allow us to evaluate our impact, identify areas for improvement, and make data-driven improvements to our platform. Moreover, we will actively seek active feedback from users, healthcare professionals, and industry stakeholders through qualitative interviews and focus groups. This feedback will complement the quantitative metrics and provide valuable insights into user experiences, challenges, and areas for improvement.

Our WeTrials solution goes directly to the core of the key problem related to clinical trials: enrollment and retention.

This problem is compounded by a long-established stigma and a lack of simplified information pertaining to clinical trials. We know for a fact that as of now, this is a complex and time-consuming process, making it difficult for patients and their families to navigate effectively.

WeTrials tackles these challenges head-on, empowering patients and their caregivers to make informed decisions about participating in clinical trials. Our 360-degree solution toward not only simplifying the whole enrollment process but also community-building, ensures that we solidify a strong position within a market where there is a real need for this type of holistic service. Simply put, the clinical trial ecosystem has not advanced well enough, and quickly enough, to break the glass ceiling of hermetic, slow processes, which usually results in patients considering such interventions as a last resort, which will eventually lead to a narrower window to prevent life-threatening situations. It is exactly in this way that WeTrials will have a considerable impact while establishing itself as the leading solution. We do not only cater to a simple need for patients; we provide a life-affirming tool to be used to simplify, destigmatize, and facilitate the enrollment of patients while providing them with a warm and empowering community of survivors.

Furthermore, WeTrials not only focuses on improving patient outcomes but also addresses the environmental costs associated with rare disease clinical trials. Through our platform, we encourage the adoption of sustainable practices and cost efficiency. The reduced “leakage” of funds will eventually lead the various stakeholders and investors to allocate more valuable resources to life-saving R&D and environmentally-ethical practices related to clinical trials.

The core technology that powers our solution, is a sophisticated online platform powered by advanced algorithms, data analytics, and user-centric tried-and-tested interface designs. The platform is cloud-based, thus ensuring the maximization of access, performance, and sensitive information security. Furthermore, our cloud-based platform is user-friendly and integrates extensive feedback from our cohort target groups and stakeholders. To this end, the platform is responsive to smartphones, tablets, and computers, thus ensuring seamless integration, inclusivity, and accessibility. The use of Generative AI, in combination with the qualitative, personal, and human elements pertaining to our main target group of patients with rare diseases, will further give us an edge in effectively bridging the gap between the clinical trials ecosystem and those who would greatly benefit from quicker, more efficient and well-informed access.

Key components of our technology are as follows:

Data Integration: We integrate and aggregate data from various sources, including clinical trial registries, research institutions, pharmaceutical companies, and healthcare providers. This data includes information about ongoing and upcoming clinical trials, eligibility criteria, trial locations, and support information like psychological, financial, and logistical variables. This process also ensures seamless scalability over the mid and long term.

Advanced Algorithms: We leverage advanced algorithms to process and analyze the integrated data. These algorithms facilitate the match-up of patients with relevant clinical trials.

User Interface (UI): We have invested in user-centric design to create an intuitive and user-friendly interface. The user interface allows patients and their caregivers to easily navigate the platform, search for clinical trials, and access relevant information.

Real-Time Updates: We ensure that our platform provides real-time updates on clinical trials. This feature enables patients to stay informed about relevant opportunities and increases the chances of timely life-saving enrollment in clinical trials.

Privacy and Security: Privacy and security of patient data are crucial for us. We adhere to strict data protection protocols and comply with applicable regulations such as HIPAA and GDPR. Patient information is encrypted and stored securely to safeguard confidentiality and maintain the trust of users.

Scalability and Flexibility: Our core technology is designed to be scalable and flexible, allowing for future expansion and integration with additional datasets and platforms. 

Nine employees and various contractors.

We have been working on our WeTrials platform and solution since 2021. During these two years, our team has invested significant time and effort into truly understanding the needs of patients with rare diseases, the challenges they and their families face, and the gaps – both institutional and social – in the rare disease healthcare space. This deep understanding, extensive experience, and commitment have positioned our team well to deliver a robust and impactful solution.

We are highly committed to promoting diversity, equity, and inclusivity. At WeTrials, we recognize that these principles are essential for ensuring fair access to clinical trials while addressing the disparities that exist in healthcare. We strive to create a diverse and inclusive trial database that encompasses a wide range of rare diseases, therapeutic areas, and patient populations. Furthermore, our matching algorithm takes into account not only medical history and health status but also cultural and demographic factors, as we recognize that different communities may have unique healthcare needs and preferences.

In addition, our team at WeTrials constitutes a representative microcosm of our vision toward diversity, equity, and inclusivity. We are proud to say that our team is meticulously selected to not only represent diverse backgrounds but to also express the best standards of both medical expertise and a healthy ecosystem of ethnic, national, and broadly intersectional diversity.

We also prioritize designing a user experience that is inclusive and accessible to individuals with diverse abilities. Our platform will adhere to web accessibility standards, making it usable for people with visual impairments, hearing impairments, cognitive disabilities, or other accessibility needs. We will conduct user testing and incorporate feedback from individuals with diverse abilities to ensure that our platform is user-friendly and inclusive. To further our vision toward diversity and inclusion, while maximizing our positive impact and feedback capabilities, we plan to support additional languages for our platform, while setting up mechanisms that will include and incorporate specific data analytics that will provide insight and actionable items focused on diversity.

Furthermore, we believe in empowering patients to be active participants in their healthcare decisions. We will collaborate with patient advocacy groups to amplify patient voices, gather feedback, and ensure that their perspectives are incorporated.

We understand that promoting diversity, equity, and inclusivity is an ongoing process of improvement. We will regularly evaluate our platform, policies, and practices to identify areas for improvement and address any biases or barriers that may arise, while actively seeking feedback from users and stakeholders to ensure that our platform remains responsive to the needs of diverse communities.

Our business model at WeTrials revolves around offering subscription services to institutions, private clinics, and pharmaceutical companies while providing patients with an entirely free application. This model allows us to generate revenue and scale up while ensuring inclusivity for patients, who will have unrestricted access to the tools they need to navigate the clinical trial process.

• Subscription Services for Pharmaceuticals, Institutions and Private Clinics:

We will offer package services specifically tailored to the needs and objectives of contracting parties. These packages will include access to our WeTrials platform with specific capabilities to optimize clinical trials and provide insight into the patient community and the clinical trials process.   Pharmaceuticals, institutions and clinics will have the ability to subscribe to our services. By offering a subscription-based model, we will provide these institutions with a cost-effective and efficient solution.

• Free Application for Patients:

At WeTrials, our primary focus is to empower patients and ensure they have inclusive access to the personalized information and support they need throughout their clinical trial journey. To this end, we will provide a completely free and user-friendly application for them. Other free features will include educational materials and access to our community support forum.

By offering the application free of charge, we eliminate any financial barriers that may hinder patients' engagement with clinical trials, thus “democratizing” this sector and breaking the current glass ceiling. We believe that every individual should have equal opportunities to be included, regardless of their financial circumstances. This aligns fully with our commitment and vision to providing patient-centered care through a deeply humanistic approach.

We will employ a multi-faceted approach to achieving financial sustainability, focusing on scaling up organically beyond project timelines while ensuring that our business continues to provide valuable services and innovation in the rare disease healthcare space:

• Non-Dilutive Grants and Funding:
• Subscription Recurring Revenue:
• Strategic Partnerships:
• Scalability and Expansion:

To support initial piloting, early product development, and go-to-market efforts, we will pursue non-dilutive grants and funding opportunities, including those provided by government agencies, foundations, and non-profits. We will leverage our team's established track record in grant applications and our compelling vision to secure such funding to create a self-sustainable system beyond project timelines.

As described in the sections above, we will offer subscription services to institutions, private clinics, and pharmaceutical companies, providing them with access to our WeTrials platform, analytics, recruitment strategies, and other resources. By offering these services through a subscription model, we establish a consistent and predictable revenue stream that can sustain the ongoing operations and growth of our business. To ensure that our subscription model is well-accepted, we will continuously refine our offerings based on feedback and industry trends, with the main goal to develop strategic and long-lasting relationships.

Strategic partnerships are vital in expanding our reach, entering new markets, and diversifying our revenue streams. We will actively seek strategic engagement and collaborations with various related organizations, both at the local, state, and federal levels. These partnerships may include data-sharing agreements, co-development initiatives, and a plethora of other activities.

A key mid-term strategy for our expansion will be our focus on scaling up our operations in as many local communities as possible in North America, with the long-term vision to expand in Latin America, the EU, and Asia. Broad inclusion and context-based feedback from these communities will ensure that we adapt, evolve, and scale sustainably toward accommodating each cohort accordingly to their local needs, as a means of financial sustainability. Furthermore, we plan to establish strategic engagement and partnerships with like-minded healthcare technology vendors that may include various partnership models.   Other examples of our strategic networking and potential toward scalability and expansion include our work with Creo (creoinc.net), which will help us focus on areas that will maximize organic expansion.

The viability of WeTrials can be demonstrated by our team’s experience in establishing financial sustainability beyond project timelines. While much of our specific monetary amounts can’t be disclosed, we can provide some relevant examples of our success without compromising sensitive financial information.

First, our team includes experts such as Sheila Mansouri and Alireza Mansouri, who have a strong track record of winning major peer-reviewed grants, including the CIHR, NIH, DOD, and UK Charity. This demonstrates our ability to secure funding from reputable sources while underlining the importance of our team’s experience in both successful program and project management and coordination.

Additionally, we are pleased to have received pre-seed funding from Akinox, a well-established, successful healthcare technology provider. They have not only provided financial backing but also expertise and a robust network of contacts and strategic advisors. Their investment in our health-focused innovative initiatives has brought about wide success which can lead to further funding and program renewal. This financial backing provides us with the necessary resources to further develop and scale our solution.

Furthermore, as an insight into our progress, we have been operational for over a year now and have recently expanded our team by hiring five new employees. This growth demonstrates our ability to attract top talent and build a capable team to drive our solution forward.

In terms of strategic guidance, we have assembled a team of advisors who bring valuable expertise in various areas. One notable advisor is Sil Lutkewitte, CEO and Chair of the Board of Directors at Targepeutics. Sil's background in the pharmaceutical industry and successful track record in developing businesses have been instrumental in shaping our path to sustainability. He has also secured grants at the state and federal levels, further validating our approach.

While we prioritize financial sustainability, we are also mindful of maintaining control and minimizing dilution of ownership. This is why we have sought non-dilutive funding options and strategic partnerships to support our growth.