Auditing/Self-inspection
An independent reliability assurance department audits all of our GCP, GPSP, and GVP services
The credibility of clinical trials is ensured through GCP audits conducted by an independent team in full compliance with GCP, protocols, SOPs and other regulations and guidelines. In addition, independent audits for post-marketing surveillance and pharmacovigilance improve reliability and confirm full compliance with GPSP, GVP and SOPs.
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Service Features
- Point 1.
- Highly skilled reliability assurance staff well-versed in ISO9001 and various areas
- Point 2.
- Extensive experience in auditing contracts for clinical trials and research, post-marketing surveillance and self-inspection
Main Services with Details
- Pharmaceutical products, medical devices, investigator-initiated clinical trials and clinical researches
- Clinical trial sites (medical institution)
- Institutional Review Board and Ethical Committee
- In-house clinical trial works
- Self-inspection of post-marketing surveillance
- Vendors including evaluation
- SOP for auditing, check list preparation
- Staff responsible for audit dispatch
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
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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 staffPharmacovigilance (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.