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
Related Service
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Monitoring
Your clinical trials will be conducted in an accurate and seamless manner through implementation of our highly efficient and professional monitoring activities.
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Patient Registration
High-quality and speedy PMS patient registration center service based on our extensive experience.
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EDC-enabled Data Management
Highly professional and capable data managers provide high quality EDC-enabled data management services in an expeditious manner.
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Biostatistics
Our highly professional “biostatistics” team has the capacity to process vast amounts of data and can accommodate your needs.
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Medical Writing
In our medical writing service, experienced and reliable professionals quickly respond to your project needs in full compliance with regulations and guidelines.
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EDC Services
Our extensive experience, expertise and lineup of system products provide full-featured EDC solutions.
(EDC system for post-marketing surveillance)
Our EDC System with speed, low cost and high-quality has been released
For more detailsFor further information onINTAGE Healthcare Inc.
If you have any questions or comments, please do not hesitate to contact us.
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INTAGE Healthcare’s Scope of Service
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Marketing Research
From OTC products to ethical drugs and medical devices, we provide complete coverage of the healthcare market
- OTC Market Research
- Ethical Pharmaceutical Market Research
- Medical Device Research
- Quick Survey
- Global Research Service
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Data Science Services
We contribute to the restructuring of a sustainable medical insurance system and the realization of optimal healthcare through various services based on data valuation concept.
- Health Economics and Outcomes Research (HEOR)
- DB Research
- Signal Management Service (Adverse Events Information Data Service)
- Drug Discovery Support
- Human Factors Engineering/Usability Engineering (HFE/UE)
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CRO Services
We support customers to solve their issues with abundant achievements, knowledge, and advanced nature in the CRO business.
- Clinical Development Support Services
- PMS Support Services
- Monitoring
- Patient Registration
- EDC-enabled Data Management
- Biostatistics
- Medical Writing
- Auditing/Self-inspection
- Pharmacovigilance (GVP)
- DB Survey
- EDC Services
- ADDIN Series
- ePRO (Patient Reported Outcomes System)
