ArkMS’s Services
Contributing to solving customer issues with 30 years of CRO experience and knowledge combined with advanced approaches
Ark Medical Solutions (ArkMS) supports the entire spectrum of operations including clinical trials and studies, epidemiological research, post-marketing surveillance (PMS), and safety information management. We also support individual operations as needed, such as monitoring or data management only. We make proposals flexibly according to our customers' needs.
With a wealth of experience, knowledge, and advanced capabilities to help solve customers’ challenges, we act as a bridge to deliver trusted data and evidence to the present and future generations.
What’s special about ArkMS
Total support CRO services and solutions with over 30 years of experience
We work closely with your project team with expertise and a solid support system
As a CRO that offers total support, we cover a wide range of operations from clinical trials and studies to post-marketing surveillance and safety information management. We offer the best proposal that strikes the perfect balance between efficiency and quality.
Number of clients
More than
100 companies
Number of academic partnerships
More than 20 organizations
Experience in the medical field
More than 30years
Number of projects
PMS500
Clinical trial/
research100
— Quality improvement that ArkMS is working on
In supporting the collection of information and preparation of materials for various applications, we give top priority to ensuring reliability and producing deliverables that meet industry standards. ArkMS is constantly making efforts to improve quality by ensuring compliance with procedures, storage of records (trails), and proper education and training. We are also actively working to raise awareness of the value of data and its deliverables.
As a CRO supporting the next generation of medical care, we constantly update ourselves with new information and technologies
We keep up to date with the latest information and technologies to remain the best partner of our customers in the ever-evolving medical and healthcare industry. Specifically, we focus on the following areas:
Working on clinical trials and studies of therapeutic apps
ArkMS was quick to start working on the area of digital therapies (DTx) and engaged in the approval and application process for the second therapeutic app in Japan. The two therapeutic and diagnostic apps we supported have received national approvals.
ArkMS has over 30 years of experience as a CRO and has engaged in a number of diverse projects in the field of medical devices, as well as in major disease areas such as tumors, cardiovascular diseases, and diabetes. We also deal with a wide range of studies and surveillances including specified clinical trials, epidemiological research, and post-marketing database surveillances. ArkMS has a great track record of supporting investigator-initiated clinical trials and academic clinical studies.
Epidemiological consultation and database research
Our staff with a wealth of experience in publications and independent research can propose research questions and a suitable database for the study when designing a research plan.
Experience in database surveillance and registry studies for drugs, regenerative medical products, medical devices, etc.
Our staff with experience working with MID-NET* and many other commercial databases can support customers you through the entire process from research planning to accompanying you to epidemiological consultations with regulatory authorities. Collaboration with external epidemiologists is also possible.
*MID-NET: Medical information database established and operated by the Ministry of Health, Labour and Welfare of Japan and PMDA
ArkMS is an active member of the Alfresa Group that engages in the total supply chain service (TSCS)
The Alfresa Group is promoting its total supply chain service (TSCS) that serves customers up to the “last mile”: from the introduction, development, and manufacturing of pharmaceutical products, etc. to their distribution, sales, and post-marketing surveillance.
ArkMS supports the development of pharmaceuticals and other medical products as a CRO in the Alfresa Group’s network.
Examples of group-wide support
Case.01 Support for emerging overseas biopharmaceutical companies seeking to enter the Japanese market
The Alfresa Group provides the PATH-Solution service, a platform that comprehensively supports your swift entry into the Japanese market, removing barriers for emerging overseas biopharmaceutical companies.
ArkMS supports market feasibility assessments, drug price simulations, and HTAs to determine the viability of market entry from the phase of reviewing entry into the Japanese market to authorization. As regulatory support, we use multiple approval routes and systems unique to Japan for pharmaceutical approval applications to reduce uncertainty for a successful approval. We also ensure transparency in the total cost of the entire process from partner selection to market launch. As post-marketing surveillance support, we take care of safety information management, patient care, and distribution control to ensure stable supply and safety.
Through the provision of the PATH-Solution service, the Alfresa Group promotes the introduction of innovative overseas drugs into the Japanese market to contribute to the elimination of drug lag and loss.
Case.02 Medical Information Customer Center
We provide centralized management services as a hub connecting patients, medical institutions, and pharmaceutical companies in cooperation with the Alfresa Group. We achieve an integrated management of distribution from order placement of drugs at medical institutions to wholesale delivery and distribution, as well as keeping track of drug administration to patients. As a trusted partner to pharmaceutical companies, we support safety assurance and the promotion of proper use of drugs as well as reliable distribution operations.
Leveraging our know-how of data relationship and operation services cultivated through CRO service, we support you as an external contact for pharmaceutical companies. By setting up dedicated contacts for patients, healthcare professionals, and MRs, and responding to inquiries and providing appropriate information, we have established a smooth communication framework and a high-quality support system.
Case.03 Switch OTC drugs
The Alfresa Group brings together its full resources to provide services ranging from application for approval and manufacturing when switching from prescription drugs to OTC drugs, to advertising and promotion, logistics, distribution, and post-marketing surveillance.
