Clinical Trial Platform Development for Patient Recruitment
Client
Our client, RxE2, is a digital health company that pioneers a novel concept of community-based hybrid clinical trials. They provide patient recruitment, dispensing, counseling, and operational services to the pharmaceutical and biotech industries.
Target Customers
The target customers of the product we’ve built are Contract Research Organizations (CROs) conducting clinical trials and in need of patients who meet specific trial protocols.
Problem
The central issue lies in the effective identification of suitable patients for clinical trials. It was imperative to go beyond the basic criteria of the trial protocol. The optimal participants would not only fulfill the protocol’s stipulations but also embody a broad spectrum of diversity and be situated within reasonable proximity to the trial’s clinical locations.
Challenge
Algorithm Development
Clinical trial protocols are complex, with many nuances, inclusions, and exclusions. We had to develop a generic algorithm yet took into account a dynamically changing large set of parameters.
Proximity to Clinical Sites
Since this is a hybrid solution, most of the trials are not entirely decentralized. They still have specific clinical sites that patients need to attend. Our system factored in geographical proximity to these sites.
Diversity
Ensuring a diverse pool of patients was critical to the success of the clinical trials. Our algorithms considered factors such as age, gender, ethnicity, and medical history.
Regulatory Compliance
It was important for us to comply with all the necessary regulations in the US, including HIPAA, ISO 27001, CFR part 11, and Validity.
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Solution
- Comprehensive Clinical Trial Solution
- Algorithmic Matching System
- Diversity and Inclusivity in Patient Selection
- Drug Dispensing Integrity
- Compliance and Security in Drug Packaging
- Cloud-Based SaaS Platform
- Behavior-Based Intervention with Habitu
- Patient-Facing Mobile Application
- Clinical Site Assistance
- AI-Driven Data Collection System
- Personalized Trial Experiences
- Pharmacist Engagement and Decentralized Trials
Comprehensive Clinical Trial Solution
Our comprehensive solution addresses every facet of the patient journey within clinical trials, ensuring a seamless and efficient process from recruitment to completion.
Algorithmic Matching System
We’ve developed a sophisticated algorithmic matching system that automates the identification of individuals who meet the trial’s requirements, considering a wide range of factors such as medical history, demographics, and trial-specific criteria. This ensures that only the most suitable candidates are considered, streamlining the recruitment process.
Diversity and Inclusivity in Patient Selection
Recognizing the importance of diversity in clinical trials, we designed our algorithm to select patients from a broad spectrum of backgrounds, minimizing bias and maximizing representativeness.
Drug Dispensing Integrity
Our dispensing module is engineered to handle the complexities of blinding and unblinding, maintaining the integrity of the trial by concealing the identity of the medication until the appropriate phase.
Compliance and Security in Drug Packaging
We adhere to the highest standards of compliance in our drug packaging process, with meticulous monitoring and control of information access, packaging operations, and assembly.
Cloud-Based SaaS Platform
intricate analytical processes, with a strong commitment to security through tools like SAST, DAST, and SIEM systems, ensuring vigilant, real-time monitoring of all system events and incidents.
Behavior-Based Intervention with Habitu
Habitu’s behavior-based intervention adapts to patient habits and life routines, optimizing every step of the E2 Trials process. The platform provides procedural support by offering required patient information and status in the trial, thereby enhancing patient knowledge.
Patient-Facing Mobile Application
It also includes a patient-facing mobile application that serves as a hub for trial operations, allowing participants to manage medications, schedule visits, and receive notifications for trial preparations and procedures.
Clinical Site Assistance
Moreover, Habitu assists clinical sites by translating patient behavior into meaningful interventions, optimizing alerts and day-to-day processes, and mapping trends to improve monitoring capabilities. It empowers clinical operations teams with insights that enable them to pre-emptively identify issues, thereby increasing trial performance.
AI-Driven Data Collection System
Our platform’s AI-driven capabilities extend beyond patient matching, offering a single integrated system for collecting both clinical and subjective data.
Personalized Trial Experiences
This holistic approach ensures a comprehensive understanding of each patient’s journey, enabling more personalized and effective trial experiences. With input from pharmacists and leveraging machine learning and predictive algorithms, our technology anticipates and addresses potential challenges before they arise.
Pharmacist Engagement and Decentralized Trials
Our distributed model localizes the decentralized clinical trial process, empowering pharmacists to quickly identify suitable trials for their patients, thus enhancing accessibility and efficiency.
Technical Implementation
Habitu Technology Platform by RxE2 operates as a cloud-based SaaS platform, supported by extensive data lakes housing anonymized data and intricate analytical processes. Our commitment to security is embedded in our development process, as we utilize a wide array of tools to fortify our system’s security. This includes Static Application Security Testing (SAST), Dynamic Application Security Testing (DAST), and the implementation of a Security Information and Event Management (SIEM) system. We maintain vigilant, real-time monitoring of all system events and incidents.
Results
At the forefront of innovation, the Habitu Technology Platform by RxE2 stands as a testament to our commitment to excellence. Catering to a broad spectrum of clients, we facilitate their recruitment and expense management processes with unparalleled efficiency. Our platform’s performance eclipses traditional methods in the market, setting a new standard for excellence.
As our flagship project, the Habitu Technology Platform is experiencing a dynamic surge in growth. We are dedicated to the continuous enhancement of our platform, crafting state-of-the-art tools that adapt to the ever-changing needs of our clients. We are optimistic that our solution will revolutionize the pace and efficacy of clinical trials, propelling them toward a future where speed and precision are the norms. With Habitu, we envision a streamlined path to breakthroughs that will reshape the landscape of clinical research.
Leveraging our custom software development for startups, we ensure that our solutions are tailored to meet the unique needs of innovative health tech companies, providing them with scalable and efficient tools to achieve their clinical trial objectives.
We needed a partner who knows healthcare and healthcare regulations to develop a web and mobile app to allow patients access to their trial team and the ecosystem in a single place. As an early startup, we worked with BeKey as a one-stop agency on all solution elements from architecture to technology selection to implementation of the MVP and beyond. It’s a fast-paced company with a high level of flexibility and ability to evolve, which was very beneficial for us.
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