Services

• Support for pharmaceutical research
• Medical Writing
• Health economic evaluation support
• Support for safety management of drugs, etc.
• Questionnaire survey support

Randomized controlled trials (RCT) are the most appropriate study design to assess treatment, and clinical trials of new drug development are conducted by RCTs. However, in the areas such as intractable diseases, rare diseases, and surgery, it is sometimes difficult to evaluate treatment methods by RCT due to the seriousness of the disease and the limitation of target patients. Also, if an RCT is performed for a treatment already used in clinical settings, the result may be inferior to generalization due to ethical issues and bias in the study population. Recently, database and registry studies using real-world data have been re-recognized and increasingly utilized by academia in pharmacoepidemiology and clinical epidemiology, pharmaceutical companies, and regulatory authorities. Real-world data can generate not only real-world treatment results but also real-world evidence, including treatment continuation rates and utilization of medical resources. In medical technology evaluation including cost-effectiveness evaluation, real-world data and real-world evidence reflecting actual clinical practice are utilized for estimation.

In order to ensure highly feasible and scientifically valid research, the staff with a wealth of knowledge and experience in outcome research using health economics and real-world data provide comprehensive research support services from the setting of clinical research issues to publication of articles.Through careful communication with our customers, we hope to serve as a robust research partner with flexible responses that meet their needs.

Real World Data Research

• Setting of research subjects
• Preparation of research plan
• Data analysis
• Publication of research results

Health Economics Assessments

• Support for cost-effectiveness research
• Systematic literature review (systematic review)
• Preparation of CTA application materials and preparation of negotiation materials

Questionnaire survey support

• CRF preparation
• Data compilation and analysis
• Analysis and report preparation