See Original Source: A media interview sponsored by Microsoft for Startups
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Sharon Chen is the CEO of AlphaPrime, a global health technology company. Prior to founding AlphaPrime, Sharon was the head of Verily China (Alphabet’s life science arm) and the Engineering Site Lead of Google Shanghai. Sharon is an IT veteran with 20+ years of rich experience in the industry, 15 of which were gained at Google. Sharon earned her bachelor's degree in automation from Shanghai Jiaotong University, and her master's degree in computer science from Texas A&M University.
Founded in August 2020, AlphaPrime focuses on developing SaaS solutions to accelerate clinical trials in life sciences by leveraging cloud computing, AI, and big data.
AlphaPrime’s clinical trials management SaaS platform AuroraPrime comprises a suite of products including Create for AI-assisted medical writing, Collect for electronic data capture, and Compute for clinical data analysis, to name a few. AlphaPrime is a full-fledged, configurable, and highly scalable system with some unique features that differentiate it from other clinical trial software alternatives on the market.
The company has recently completed a multi-million-dollar A+ financing, led by Han Kang Capital, followed by B Capital. The team at AlphaPrime consists of tech gurus and clinical experts with extensive experience in leading global companies, such as Verily, Google, Medidata, and Veeva.
Below is an interview with AlphaPrime’s CEO Sharon Chen. Text has been edited for brevity and clarity:
The life cycle of clinical trials in the medical industry can be broken down into three major scenarios: clinical trial design, data capture, and final analysis and report. AlphaPrime offers products that cover all three scenarios of the clinical trials life cycle in a unified, versatile, intelligent, and advanced manner.
Let's talk about the first scenario, which is the protocol design of the clinical trials. It's a crucial part of the process because it defines how the research will be conducted, what kind of data will be collected and in what ways, and how the report will be submitted to regulatories authorities such as the U.S. FDA and China NMPA to assess the efficacy and safety of drugs or medical devices.
The protocol's design is eventually written down in the document, so AlphaPrime supports this with a very intelligent, template-based, collaborative tool called Prime Create. The key function of Prime Create is to support content recommended by the AI model, plus a collaboration tool for you to design, write and review the content very efficiently. Finally, there is an official approval process to sign off on the accuracy and completeness of the documents.
The second scenario is the data capture phase, which is a critical component of the drug development process. Electronic data capture, also known as EDC, is a well-established field with many offerings in the market. However, our advantage lies in the powerful features built around the collection process.
Our EDC product, Prime Collect, includes the randomization and Trial Supply Management system RTSM. This integration eliminates the need to switch between different systems and re-enter information.
Our company also offers decentralized trials, which is a remote way of collecting data empowered by portable or home devices, tele-visit, remote monitoring, and many other different offers. Our expertise lies in combining all these different data sources seamlessly, without any extra effort.
Overall, our comprehensive EDC and decentralized trial offerings make us stand out in the market, and we are confident in our ability to meet the diverse needs of our clients.
The final scenario of clinical trials is a crucial part of the cycle. It involves analyzing data and generating a final report that proves the efficacy and safety of the device or medicine being tested. This phase is essential for satisfying the requirements of regulatory departments. Prime Compute is a major product that facilitates this process.
The strength of the entire system lies in the provision of out-of-the-box standard templates and libraries, algorithms, models, analysis methods, and final visualizations. These features are designed to make the process of data analysis as seamless as possible. The aim is to minimize the effort required to analyze and report the data generated in clinical trials.
I will highlight two key technologies: Clinical Logic Engine and Compose.
Clinical Logic Engine is our main strength of the AuroraPrime system. It is AI-powered, and it is the underlying engine of the system, driving the data flow and the processes.
Evidence-based data is required in a structured manner from the protocol design to the final report submitted to the regulatory body. However, due to the distributed and diverse nature of each segment of the cycle, different expertise is needed to work on different parts. This makes it difficult for them to communicate with each other or work together using the same language. To solve this problem, we built a Clinical Logic Engine to automate the process and translate data from one part to another.
For example, for certain diseases and phases of clinical trials, we broke down the inclusion and exclusion criteria and the visiting schedule, so the computer system can comprehend each element. This drives the automation of database building, allowing for the collection of clinical trial data in a structured manner. Eventually, it can populate the final clinical study report based on the initial protocol and the resulting biometrics. This back-end engine empowers the data flow throughout the lifecycle of a clinical trial.
We have developed a homegrown highly-adaptable (technically known as low-code) platform called Compose, tailored for the clinical trial industry. Our CTO, Xu Pengcheng, has led the effort for about two years to build this from the ground up.
We have a few applications built on top of Compose, such as Compute, which is our analysis tool and system to run analysis on top of the medical and operational data of the clinical trials. We also provide visualized reports and dashboards for clinical trials.
We want to tailor our offering of highly-configurable Coordinate, an ERP-like tool to manage clinical trials, known as Clinical Trials Management System in the drug development industry, to support the growing demand of the customization needs of our clients. We provide this tool via a set of out-of-box standard templates, and libraries together with a low-code platform for the customers’ IT department to be able to write simple code to fulfill their own SOP demands.
AlphaPrime also focuses on consumer health development. The product family is called AuroraEssentials, which empowers the development and commercialization of consumer cosmetics.
The suite of products can be flexibly reassembled to support clinical trials for the cosmetic industry. They have quickly expanded from clinical trials to real-world evidence, utilizing de-centralized trials to collect more data.
AlphaPrime life science is a global company from the very beginning, with offices or registered entities already in Singapore and Shanghai. We started from China because we see the strong demand of this fast-growing market. We really want to capture the wave of the opportunities.
The health industry — medicines, the device invented, the innovation from biotech or pharma companies — really needs to serve human beings across the globe. So the final market is global, and so is our company.
Our expanding market strategy is based on the whole market demands. For example, the United States is one of the major or leading markets, and we are planning to expand our business to the United States very soon. Europe is another giant market and we are working on that as well. Biotech and biopharma companies often use the Australian and Southeast Asian markets for their clinical trial market as well, so we will also look for opportunities in those markets.
In summary, we are looking at all the possible global markets and based on the priority of how soon and how quickly we can work with our biotech companies together.
We really appreciate the great support from Microsoft. AlphaPrime is one of the companies sponsored by Microsoft for Startups. Microsoft has been spending years supporting and empowering local startups here in China. We highly appreciate the great benefits of this program, including the office space offering at the beginning, Azure cloud capacity, and the co-marketing opportunities supported by Microsoft for Startups.
AlphaPrime’s public cloud-based SaaS platform uses Azure as one of our major cloud providers outside of China. AlphaPrime system is designed to comply with regional regulations, via a cloud-agnostic technique. We are ready to fully support US solutions in the States.