EDC-enabled Data Management
Highly professional and capable data managers provide high-quality services in an expeditious manner.
We plan and implement data management projects in full compliance with GCP and GPSP with a particular focus on the validity of and consistency in the enormous amount of data. Through our thorough quality control, we provide high-quality data from the beginning to the end of all projects.
Overview of EDC Services
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Service Features
- Point 1.
- GCP, GPSP and regulation-compliant DM
- Point 2.
- High-quality and consistent service delivered by highly-skilled professionals with experience
- Point 3.
- IT-driven data management approach, e.g. EDC
Main Services with Details
GCP
We prepare the following draft documents:
- CRF
- Data management operating procedure (plans)
- Data base design and development, entry system
- CRF checklist (reexamination requirements)
- Logic check specifications
- Logic check program
- Data entry and corrections, coding
- CRF check (logic and manual), reexamination request (queries)
- Clinical conference materials
- EDC system setup
- System validation
- Data management operating reports
PMS
We prepare the following draft documents:
- Data management operating procedure (plans)
- Data base design and development, entry system
- CRF checklist (reexamination requirements)
- Logic check specifications
- Logic check program
- Data entry and corrections, coding
- CRF check (logic and manual), reexamination request (queries)
- AEs data matching
- Coding data maintenance
- System validation
- Data management operating reports
- On-site data management service
- Data managers dispatch
Related Service
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PMS Support Services
We provide various services to respond to the various PMS issues facing our clients.
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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 Services
Our extensive experience, expertise and lineup of system products provide full-featured EDC solutions.
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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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Auditing/Self-inspection
An independent reliability assurance department audits all of our GCP, GPSP, and GVP services.
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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.
Lineup of PMS-EDC services
- ADDIN
- Viedoc
- PostMaNet
- Rave
(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
-
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)
