Our Three Core Businesses
Clinical Research & Development Business
Many of the main trends in pharmaceutical product development in recent years have been concentrated in the areas of oncology, central nervous system (CNS), and immunology. The founding members of Linical possessed a wealth of experience in immune system diseases, and ever since they started the company, a major part of the services they have provided have been in this notoriously difficult area. Over time, they then steadily and surely expanded their range of services. In Japan they branched into the specialist areas of CNS in 2006 and oncology in 2010. The result is that our current business is now focused on addressing “unmet medical needs” in oncology, CNS, and immunology. Our business, built around these three main pillars, now boasts a strong track record featuring numerous successes stories.
When Linical was established, it initially provided only monitoring and QC services, but we are now equipped to deliver back-end services like data management and statistical analysis, as well as comprehensive services such as project management to coordinate and manage all aspects of the process. Additionally, we undertake vendor management related to IxRS and specimen and investigational product (IP) management.
With this solid development system now in place, we support numerous global development processes.
Ever since Linical was established, we have specialized in monitoring and quality control (QC) as our business has grown and evolved, so this is one of our true strengths. At Linical, we generally refer to services that interface closely with clients as “front end” services. And as “front line” professionals in clinical development, we are committed to guiding projects to success.
As clinical studies become rapidly globalized, in recent years more and more trial sponsors have been outsourcing a comprehensive set of services, including not only monitoring and QC, but many other functions. Thus, demand for project managers is rising year by year.
Linical maintains a talented staff in Japan with a great deal of experience in project management for global trials, including experience in Europe and the USA. These personnel of various nationalities can communicate in Japanese, as well as in English and in their native language. All of them can conduct their management-related communication with trial sponsors in Japanese. Furthermore, to cultivate Japanese project managers, each year we send some of our Japanese employees to work at a European subsidiary. This further helps to prepare Linical for the challenges of market globalization.
In the future, Linical will continue to enhance its management capabilities in its home base of Japan, to strengthen its support for Japan-led global trials.
Linical’s monitoring is based on “enthusiasm,” the “spirit of inquiry,” and “integrity,” as expressed by the company’s logo and culture. Our “enthusiasm” for the drugs we develop spurs-on the people around us, and with our “spirit of inquiry” we strive relentlessly to find and reflect on any lack or deficiency, to continually improve ourselves. We understand too that “integrity” means to analyze the current reality calmly, whatever the situation, and to keep responding earnestly and appropriately.
This attitude cannot be developed overnight. Linical has established an environment and culture that fosters this attitude in employees. In large, this is the result of our system of training, which is substantial both in terms of quality and quantity, as well as through the guidance of the company’s president and the thorough education of our management. These efforts help our CRAs mature into true professionals equipped with “enthusiasm,” the “spirit of inquiry,” and “integrity.”
With their unshakeable commitment to these qualities, Linical CRAs are able to execute their work according to the directions of clients, and also to sensitively grasp the needs of a project through close communication with trial sponsors and medical institution staff, thereby providing added value, as professionals.
Quality Control: QC
Linical’s Quality Control Department (QC Department) ensures that we not only guarantee the quality of clinical trial processes, but also deliver high-quality results. More specifically, the department implements the following:
- (1) Creation of SOPs relating to QC
- (2) Checking of work related to clinical trial-related requests, contracts, and completion procedures
- (3) Checking of work related to collection, evaluation, and communication of safety information
- (4) Checking of work related to investigational product (IP) management
- (5) Checking of work related to handling of case report forms and other clinical trial data
- (6) Checking of monitoring reports
- (7) Checking the content of clinical study reports (CSRs)
- (8) Storing records related to the above work (including eTMF handling)
- (9) Handling of compliance surveys
Linical’s QC staff also get actively involved in projects, giving advice on compliance to GCPs, SOPs, and the relevant protocols. By communicating with monitors and working together to resolve issues and providing guidance to less-experienced monitors, the QC staff make an important contribution to the final goal of achieving drug approval.
Over recent years, there has been a growing tendency for clients to outsource all the work involved in conducting clinical trials to CROs. The main reason behind this trend relates to the fact that managing various vendors has become more complicated, especially in the case of global trials, so clients feel more like contracting the work out to CROs. As the business becomes increasingly globalized, Linical has started to serve as a contact for vendors, to address this growing need of trial sponsors.
More specifically, we communicate with the vendors who handle things like clinical examinations, investigational product (IP) management and distribution, and we select and propose vendors that best suit the client’s needs. As and when necessary, Linical itself enters into contracts with vendors, and to advance the clinical trial smoothly, it conducts various kinds of meetings, creates documented procedures, and deals with problems as they arise.
We have accumulated considerable experience serving as a contact for vendors (of clinical examinations, electrocardiograms (ECGs), IP management and distribution, and IWRS) when working on Asian (Japan-Korea-Taiwan) clinical studies, so our clients can feel completely assured and confident in using Linical for this kind of service.
The Linical Group’s Quality Assurance (QA) Team implements monitoring work and performs auditing on global trials conducted under contract in different countries, as a one-stop service. In the auditing of physician-led clinical studies and clinical research, the team also proposes auditing tasks to be performed at medical institutions to ensure sufficient quality. We believe that the quality of clinical studies and clinical research is influenced not only by the quality of study implementation and monitoring, but also by the quality of auditing. In the coming years, we will be improving the quality of our auditing work, making use of all the accumulated auditing experience of the Linical Group.
More specifically, the services offered by the QA Team include GCP auditing of (company-led and physician-led) clinical studies, auditing of (company-led and physician-led) clinical research (implementation of auditing in accordance with applicable laws and regulations, guidelines, and protocols), creating documented auditing procedures for various kinds of auditing, and auditing-related consulting work.
Regulatory agency handling service
Linical has a track record of more than 10 years in the Clinical Research and Development Business—a key element of the company’s business. Currently, Linical is building its business with a strong focus on services for “unmet medical needs” in the three main pillars of oncology, CNS, and immunology, all of which are notoriously difficult. We have successfully undertaken many contracts, including for services in other areas of medicine. Through all this work, we have accumulated extensive experience in handling GCP compliance surveys (documentation and implementation reviews). With this strong track record and wealth of experience working with major pharmaceutical companies, our staff are well equipped to deliver a wide range of services, such as general consulting on application procedures, preparing application documents, and creating or assisting with responses to inquiries and opinions.
At Linical’s overseas subsidiaries, our staff in charge of regulatory affairs deal with regulatory agencies as in-country clinical caretakers.
At its data center in Europe (Madrid, Spain), Linical has stationed a highly professional staff of specialists in IT, biostatistical analysis, and data management — all of them well-versed in clinical development. In collaboration with experts in various fields and through sophisticated processes, they ensure optimal efficiency and global quality of the Front-end (field monitoring services). To enable our clients in Japan to communicate smoothly with our staff, we have native Japanese-speaking staff stationed in Spain, as well as liaisons in Tokyo, Japan and Seoul, South Korea.
Data Management (DM) service
Through our utilization of an up-to-date EDC environment (Oracle InForm G, Medidata Rave) and data processing handled by personnel who have completed SCDM training, Linical can deliver “faster, more accurate, and more economical” services. In global trials, we can handle data collection and query processing in multiple languages, and we have plenty of experience in integration with external data and output to CDISC standards.
Statistical analysis service
At Linical, biostatisticians who are highly experienced in working on clinical studies in a variety of areas and phases handle everything from the stage of trial planning to the creation of reports. We also have dedicated SAS programmers to ensure blinding, for quality control of programming code, and for life cycle management.
Medical Writing (MW) service
Linical has highly experienced (English-language) medical writers as full-time staff members. In collaboration with medical specialists and biostatisticians, they produce work of very high academic standards.
Linical has dedicated EudraVigilance-certified staff. This enables us to construct a safety database (Oracle AERS) for use in the global trials handled by Linical. In collaboration with medical specialists (physicians) who work full-time at the same facilities, we also offer contract services such as side-effect evaluation, and creating CIOMS reports and ICH ICSR documents.
Medical Management (MM)
Linical has five full-time physicians in the EU region as medical experts in the fields of oncology, pediatrics, internal medicine, and epidemiology. In accordance with their (fundamental) medical knowledge, they perform services relating to trial subject suitability, SAE evaluation, medical terminology, and thesis review.