Clinical Development Support Services
Extensive achievements, knowledge, and advancement to support clinical trial projects
We work for our clients’ success with efficient GCP and Clinical Development Support Services, including regulatory support before the start of clinical trials. We are flexible enough to cover specified clinical trials, observational studies, investigator-initiated clinical Trials, academia supports, with our monitoring, clinical trial coordination office, DM/EDC, biostatistics, and clinical study protocol/reports and so on.
Service Features
- Point 1.
- Consulting and proposals by experienced clinical research and clinical trial experts
- Point 2.
- Project management with a "one-team system" including clients
- Point３.
- Project implementation working close to the clients that shares the significance of clinical trials and research and the intention of development
Main Services with Details
Monitoring
- Consultation throughout the entire clinical development
- clinical trial coordination office
- Monitoring and coordination with medical institutions
etc.
Data Management, EDC Support
- Data base design and development, entry system
- CRF check (logic and manual), reexamination request (queries)
- EDC system setup
etc.
Biostatistics
- Preparation for statistical analysis plan
- Consultations on overall biostatistics
- CDISC-standard (SDTM, ADaM) data preparation
etc.
Medical Writing
- Preparation for clinical study report
- drafting a protocol
- drafting an Informed Consent Form
etc.
Auditing
- Audit for Pharmaceutical products, medical devices, investigator-initiated clinical trials and clinical researches
- medical institution audit
- SOP for auditing, check list preparation
etc.
EDC Services
- Consultation service for EDC installation
- User training
- Import of external data, export of data
etc.
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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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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Auditing/Self-inspection
An independent reliability assurance department audits all of our GCP, GPSP, and GVP services.
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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.
Contact UsINTAGE 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)
