serviceSignal Management Service (Adverse Events Information Data Service)

Signal management support services with a focus on post-marketing pharmacovigilance spontaneous reporting system data (SRS Data*)

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*SRS Data: Spontaneous Reporting System Data

Database Services

We provide cleaned and curated databases using FAERS and other databases. Signal calculation results and master information can be added.

*FAERS (FDA’s Adverse Event Reporting System): a public database administrated by the FDA containing adverse event reports, medication error reports and product quality complaints resulting 

System Services (CzeekV Pro/CzeekR)

We provide the Czeek series. It is widely used in pharmacovigilance activities, research activities, and clinical practice. We also post various information via our blogs, mail magazines, SNS, etc.

Data analysis Outsourcing Service

Signal reports are provided on a regular basis at the time of database update. Analysis supports for research on RWD/SRS data are available. We also provide consultation about the study design, development of research questions and proposal of analysis methods.

*RWD: Real World Data (Anonymized data of individual patients derived from clinical practice) Typical examples include receipt for health insurance claim [statement of medical expenses] electronic medical records, patient registration registries, etc.)

Consultation related to clinical research

We conduct training courses with a focus on overseas pharmacovigilance information centering on SRS data, regulations on signal management, research information, and various analyses. We also provide support for signal management.

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