Signal Management Service (Adverse Events Information Data Service)
Signal management support services with a focus on post-marketing pharmacovigilance spontaneous reporting system data (SRS Data*)
image scroll
*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.
For further information on
Ark Medical Solutions Inc.If you have any questions or comments, please do not hesitate to contact us.
Contact UsArk Medical Solutions’s Scope of Service
-
Clinical Development Support Services
From OTC products to ethical drugs and medical devices, we provide complete coverage of the healthcare market
- Monitoring
- EDC-enabled Data Management
- Biostatistics
- Medical Writing
- Auditing/Self-inspection
- EDC Services
-
PMS Support Services
We provide various services to respond to the various PMS issues facing our clients.
- Patient Registration
- EDC-enabled Data Management
- Biostatistics
- Auditing/Self-inspection
- Medical Writing
- Auditing/Self-inspection
- EDC Services
-
DB Research/DB Survey
A wealth of experience in using real-world databases
Comprehensive support for database surveys/database research by highly professional staffPharmacovigilance (GVP)
Providing speedy and reliable pharmacovigilance service through our well-established team of highly skilled professionals in GVP operations.
-
ADDIN Series
ADDIN series, our EDC system which prioritize operability for physicians who are in charge of post-marketing surveillance, assures efficient and high quality data accumulation/progress management at your survey project.
-
ePRO (Patient Reported Outcomes System)
We provide optimal ePRO system for collection of patient outcome data.
-
Signal Management Service (Adverse Events Information Data Service)
We provide statistical analysis services for adverse event database systems and real-world data of various drugs by utilizing "FAERS" and "JADER," spontaneous adverse event databases collected/published by FDA and PMDA.