Linical is developing both our CRO business, which supports clinical trials conducted as part of the pharmaceutical product development process, as well as our Contract Medical Affairs Business, which supports post-marketing surveys and clinical research.
The process of pharmaceutical product development
R&D on pharmaceutical products can be broadly divided into two stages: research, and development. At the research stage, there is fundamental research to create a new substance and select it as a candidate for pharmaceutical product development. Then in non-clinical study (animal experiments), laboratory animals are used to assess the safety and effectiveness of the substance. At the development stage, a plan is formulated for administering the substance under investigation to humans in clinical trials, to examine questions such as what kind of patients it is suitable for, in what quantities it can be used safely and effectively, and how the substance can be differentiated from existing therapeutic agents. After all the stages of research and development are completed and approval is granted by the relevant regulatory agency, sales of the new drug can commence. Pharmaceutical companies then conduct post-marketing surveys on the new drug, by conducting follow-up surveys on side-effects and the scope of the drug’s effectiveness, as these may not have been clearly discerned from the clinical trials.
The role of CROs
Companies like Linical, that carry out a part of the work involved in the clinical trials process of pharmaceutical product development and post-marketing clinical studies, or that support such work, on behalf of pharmaceutical companies, are known as CROs (Contract Research Organizations). The tasks involved in clinical trial work are many and various. They include monitoring whether or not clinical trials at the development stage are conducted in strict compliance with the Pharmaceutical and Medical Devices Law, other applicable laws and regulations, and trial implementation plans, as well as related quality control and consulting work; data management work to create a database of case reports consisting of data on the effectiveness and safety of patients administered the experimental drug; medical writing work to prepare various kinds of documentation for submissions to supervisory authorities, e.g., trial implementation plans, notifications, and application documents containing data obtained from the trial; and auditing work aimed at verifying the reliability of trial data by assessing the implementation of the trial. In the past, such tasks were always conducted directly by pharmaceutical companies, but in recent years, the proportion of companies outsourcing such tasks to CROs has risen. Thus, the CRO market has been steadily growing.
Features of the Linical Group
1. Specialization in specific tasks
Linical focuses strongly on monitoring work, which is the main task in clinical trials. In our monitoring services, we select the medical institutions at which to conduct trials, finalize agreements and contracts, explain the trial drug and trial plan to physicians, check compliance with trial rules, manage progress, and collect trial data. The work of monitoring is important for ensuring the smooth running of a clinical trial, and it requires highly specialized knowledge and accurate judgment.
2. Specialization in specific clinical trial stages and diseases
Linical’s business is focused principally on the main stages of clinical trials — Phases II and III — and in the areas of oncology and CNS (Central Nervous System), in which new drug development expectations are particularly strong. Phases II and III of clinical trials, which are focused directly on patients, are generally difficult, requiring substantial amounts of time, money, and labor. Furthermore, since it is notoriously difficult to evaluate drug safety and effectiveness in oncology and CNS, considerable skill and experience are required in these areas.
3. Specialization with specific clients
Linical has worked mainly with major pharmaceutical companies, which are constantly initiating product development and approval applications. Major pharmaceutical companies implement state-of-the-art pharmaceutical product development on a continuous basis, so by working on contract for these companies, we can accumulate further knowledge, technical expertise, and experience. At the same time, by delivering high-quality work, we have built trusting relationships with clients, allowing us to win more contracts.
4. Increasing globalization
Linical is working intensively to globalize our business to handle international clinical trials as the demand for such trials by pharmaceutical companies continues to grow. By conducting international clinical trials when developing new drugs for multiple countries or regions, pharmaceutical companies can benefit by getting new drugs released in their main market countries sooner, and also by getting their products released simultaneously in multiple markets, thereby allowing them to increase brand penetration in international markets and maximize financial returns. To offer one-stop support for international clinical trials, Linical has set up bases of operation in different parts of Asia (including Japan), the USA and the EU.