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
image scroll
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
For further information on
INTAGE Healthcare Inc.If you have any questions or comments, please do not hesitate to contact us.
Contact UsINTAGE 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
-
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)
-
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)