Consultation related to clinical research
Based on our extensive experience, knowledge and accumulated information from research, we provide support and consultation in various aspects.
- Analysis specification review/analysis method proposal
Proposal of coding in light of database characteristics/features, proposal of use of master, support for statistical analysis, proposal of study design, etc. - Joint research support
Data curation, statistical analysis, calculation support, etc. - Signal management
Suggestions for signal management using post-marketing pharmacovigilance spontaneous report data (SRS data*) (database selection, coding in light of database characteristics/features, master utilization, curation, signal detection conditions, etc.) - Contracted system development
Proposal of system development for pharmacovigilance activities - Data mining workshop
Provision of training on signal management in data mining in response to customer requests
<Examples of training contents>
Introduction of domestic and overseas research cases related to SRS data*, examples of signal utilization, details of signal calculation, introduction of research cases, etc.
*SRS Data: Spontaneous Reporting System Data
For further information onArk 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
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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
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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
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DB Research/DB Survey
A wealth of experience in using real-world databases
Comprehensive support for database surveys/database research by highly professional staff
Pharmacovigilance (GVP)
Providing speedy and reliable pharmacovigilance service through our well-established team of highly skilled professionals in GVP operations.
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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.
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ePRO (Patient Reported Outcomes System)
We provide optimal ePRO system for collection of patient outcome data.
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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.
