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 onArk 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 staff
Pharmacovigilance (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.
