serviceDatabase Services

Post-marketing pharmacovigilance spontaneous reporting system database (SRS Data*)

Case reports on adverse events are accumulated in the local post-marketing safety reporting system. SRS data, which have strengths in signal detection, further exploration of safety hypotheses, and enabling appropriate regulatory decision-making and action, are used in signal evaluation and clinical research.
We provide a database where data maintenance and signal calculation have been conducted after data acquisition.
Please contact us for more information about the scope of data and frequency of service.

*SRS Data: Spontaneous Reporting System Data

[Database maintenance flow]

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[Provided databases]

FAERS, VAERS, CAERS
Please contact us if you are considering using an SRS database other than the above.

*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
*CAERS (CFSAN Adverse Event Reporting System): a public database administrated by the FDA containing information such as adverse events and product complaint reports for foods, dietary supplements and cosmetics
*VAERS (Vaccine Adverse Event Reporting System): a public database administrated by the FDA containing post-vaccination adverse event report information

We also accept the following requests:

• Annual contract (service provided at the time of every database update,) one off service, etc.
• Adding score value as a result of signal calculation
• Consultation on details in coding process
• Providing master (e.g. adding compound information from provided drug master, providing CAS registration number, etc.)
• Proceeding with curation while looking at information described in raw data

The specifications will be formulated after an interview on the database to be analyzed, details of curation, analysis method, etc.
Terms to be linked to master information are provided according to your contract status.

[Circumstances in foreign countries]

In other countries, it is mandatory to incorporate the process of pharmacovigilance process using SRS data as one of the regulations on pharmacovigilance activities. It is usually used for early signal detection by data mining. However, it is also used for evaluation of relationship with drugs, signal evaluation, and assessment with reasonable certainty in addition to ordinary signal detection. In such cases, analysis methods that take into account various information reported in case reports are applied. For example, methods considering stratification by age group are also used. There have been many research reports including new analysis methods.

RWD* and RWD utilization services other than the above databases

INTAGE Real World Inc., our affiliate company, provides “Integrated Medical Database (Cross Fact)” and “drug database (DI Track).”

*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.)