We are gathering various solutions from around the world to streamline Clinical Operations and Data Management, and accelerate Drug Development.

As shown below, Magoneko has a wide range of products covering everything from the early stages of Clinical Development to New Drug application. Our solution lineup includes basic solutions such as EDC and CTMS that are already used as standard in Clinical Development work, as well as cutting-edge solutions that have been developed to solve conventional problems and are expected to become mainstream in the future. We are offering these two types of solutions.

The core solution is Clinflash® Cloud, which covers almost all operations necessary for Clinical Development. We also offer products from AiCure, Akyrian Systems, and Saama as solutions for business reforms and efficiency improvements using cutting-edge AI-based technology. In addition to these IT solutions, through our business partnership with London-based Richmond Pharmacology, we are now able to assist with conducting Phase I clinical trials in the UK, including Japanese subjects. This will enable us to further speed up and streamline clinical development in Japan, helping to resolve issues such as drug lag and drug loss.

In addition, the product lineup is being expanded gradually, and we will notify you of any products that are scheduled to be added (products surrounded by dashed lines in the chart below) as appropriate through our web page.

AiCure is a company that has been in the eClinical marketplace for 15 years, with its roots starting with funding from the US National Institutes of Health to research the use of artificial intelligence in patient care. At present, AiCure is seen as the leading resource in the world to address the issue of medication adherence in clinical trials. AiCure's product is a highly differentiated and patented system that uses computer vision and machine learning to make assessments of patient audio and video to provide determinations of patient behavior, such as protocol adherence. AiCure also uses its platform to assess audio and visual phenotypes of disease in the form of biomarkers used in research.

During COVID-19, with a growing demand for remote and decentralized solutions, AiCure was seen as a unique value because of its years of experience deploying and supporting patient-facing software. AiCure responded by developing compliant telemedicine solutions for its sponsors. Also, AiCure launched Clinical Site Services (CSS) to relieve technology burden at sites.

Today, AiCure continues to innovate and broaden its market presence as a platform for all things patient-facing. This includes eConsent, ePRO/eCOA, telemedicine, AI-driven patient engagement via two-way text, and of course, medication adherence and digital biomarkers.

AiCure has a proven record with dozens of clinical trials sponsored by the most prominent Big Pharma companies in the world. Its AI-platform has been deployed in over 40 languages. Importantly, AiCure has supported studies in all phases of drug development leading to FDA submissions, projects in post-marketing research, city- and state-wide deployments in public health, and large US Government and military contracts.

In 2015, a team with years of experience in building e-Clinical solutions decided to pursue the next frontier in clinical data capture. Noting that the flow of data from electronic health records (EHR) to electronic data capture (EDC) was still driven entirely by manual transcription, and frustrated that decades of integration efforts using interoperability standards were yet to yield ubiquitous results, the team set out to build a system that would enable frictionless data collection at clinical sites in a way that would be EHR-agnostic while re-imagining operational processes to eliminate time-consuming and wasteful habits for all stakeholders involved.

They created Akyrian Systems, and the result of years in R&D led to Akyrian’s flagship product, Source Data Extraction or SDE, a patented clinical data platform that is now poised to significantly reduce clinical trial duration and overall cost.

Clinflash Healthcare Technology (Jiaxing) Co., Ltd is a healthcare information technology company headquartered in Jiaxing, Zhejiang Province, People's Republic of China, providing cloud platforms and professional services for Clinical Development. Clinflash was founded in 2014. In 2018, it was recognized by the Chinese government as a national high-tech enterprise, and currently supports the development of innovative drugs, generic drugs, medical devices, in vitro diagnostics, etc. with over 12 product lines. It also supports international quality and industry standards such as ISO 9000, ISO 20000, ISO27001, ISO27701 certification, compliance with FDA 21 CFR Part 11 and CDISC standards. Clinflash offers high quality, robust and superior systems.

Services for Japanese customers are provided by the system within a cloud data center in Japan.

Richmond Pharmacology has over 20 years of experience conducting over 100 Phase-I trials in London targeting Japanese volunteers, and is a very unique CRO with the largest Japanese database (24,000 people) of any facility based in Europe, and has a track record of being used by many clients, particularly those planning international joint clinical trials. In addition, recently, trials targeting specific patient cohorts have accounted for approximately 60% of the total number of trials, and the company is also focusing on clinical trials in the fields of gene silencing and gene editing. While accurately grasping the needs of the times, the company is working hard to accelerate research using adaptive designs and provide "Faster Answers."

Saama’s mission is to improve lives by accelerating the delivery of therapies to patients.

Saama uses artificial intelligence (AI), along with advanced analytics, to automate key clinical development processes and surface actionable insights. This allows customers to accelerate their time to market and eliminate manual, resource-intensive processes.

Saama accomplishes this mission through the combination of our strong portfolio of SaaS-based solutions, ready for deployment out-of-the box, as well as our ability to work with your organization to build and deploy custom AI and advanced analytics-based solutions. This combination of capabilities means we can cover the entire spectrum of clinical development and commercialization.

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