Clinical Development Services and Solutions
*Currently we have experience in clinical trials for the therapeutic areas of cardiovascular, infectious diseases, cancer, dementia, rheumatism, and vaccines.
Screening and Selection of Candidate Medical Institutions/Principal Investigators for Clinical Trials
We select relevant medical institutions and principal investigators based on the precise understanding of the objective , cohort size, and other details described in the clinical development plan, and various guidelines applied to the trial (including facility selection policies).
Requesting and Contracting Medical Institutions for Clinical Trials
In the negotiation process with medical institutions and principal investigators, we explain the details of the clinical trial plan (protocol) sufficiently enough to answer their questions and obtain their consent. After the contract is concluded, we successively explain various cautions and reminders to investigational agent administrators at medical institutions with regards to the transfer of investigational agents, and their storage and handling methods.
Monitors, who have the expertise and knowledge of various therapeutic areas and strong ethical commitments, conduct monitoring of clinical trials in accordance with the Pharmaceutical Affairs Act, GCP, clinical trial protocol and standard operating procedures (SOPs), so that trials are executed smoothly. Moreover, we are also working to innovate the monitoring process using information and communications technology (ICT).
Clinical Trial Quality Maintenance and Improvement (Quality Management)
Quality management staff with the expertise of regulatory requirements and experience with the practices of clinical trials conduct inspections, assessments, and feedback on whether the clinical trial is being carried out in accordance with the Pharmaceutical Affairs Act, GCP, clinical trial protocol, SOPs, whether documents and records are complete, and whether there have been any legal violations, to ensure the quality and reliability of the trial. Nonetheless, we are not satisfied with just keeping the appropriate quality of documents and records, but make continuous efforts to improve their quality through the analysis of identified issues.
Creation of Seamless Development Processes (Clinical Development Platform)
Constructing seamless development process (clinical development platform) is a Key Success Factor in managing the development of pharmaceutical products effectively. We are working to build a comprehensive development service package, including data management, biostatistics and document preparation for approval applications.