EDC Services
Our extensive experience, expertise and lineup of system products provide full-featured EDC solutions.
Our wide variety of EDC services, including our in-house EDC system “ADDIN,” provide solutions best suited to accommodate your project size and budget. Our services range from support for designing EDC to data management operation and take full advantage of every EDC feature.
Service Features
- Point 1.
- Our highly experienced professionals are responsible for your project from designing the system to all operations.
- Point 2.
- Our proposals are designed to accommodate your specific project size and budget.
Consultation service for EDC installation
- Support for preparing SOP
- Consultations on CSV
Services to provide international safety information
- Design and development of eCRF screens
- Design of data validation specifications and logical check construction
- Preparation of data entry manual
- User training
- Management of sites and users
- Progress management
- Manual check
- Query management (query preparation and submission, data lock)
- Import of external data, export of data
- Delivery of data in SDTM by CDISC
Lineup of GCP-EDC services
- marvin
- Medrio
- Fountayn
- Rave
- Viedoc
Lineup of PMS-EDC services
- Viedoc
- PostMaNet
- ADDIN
EDC Solutions Partners
Marvin, Xclinical
Developed jointly with physicians at Xclinical, Germany, and has been used for various studies and researches since 2002.
Marvin is used in 1200 studies in 69 countries worldwide, and has been used in more than 50 studies in Japanese clinical trials including company-sponsored clinical trials, investigator-initiated trials, clinical development, epidemiological studies, and switch OTC clinical trials.
ClinCloud Ltd.
We provide our EDC (Electronic Data Capture) for clinical studies, Fountayn(Pre Datatrak Enterprise Cloud). In the Electric Data Capture, all over the world 83 counties, more than 5,500 studies have been run and it is the most proven track record of EDC system. All the features required of EDC system are aggregated and included in one platform and user interface. Experience our services with Fountayn to reduce costs and the efficiency in conducting clinical studies.
ClinCloud Ltd. Corporation Website
Medidata Solutions, Inc.
Medidata Solutions, Inc. is a leading cloud-based company that transforms clinical development for the life sciences industry with advanced applications and data analytics capabilities, and has been supporting the development of life sciences. Medidata has more than 800 global pharmaceutical companies, innovative biotech, diagnostic and medical device manufacturers, leading academic medical centers, and CRO (contract research organizations) as its customers.
The Medidata Clinical Cloud® is committed to improving the productivity and quality of clinical trials from study design and planning through to execution, management and reporting of promising therapies for 17 of the 25 global top pharmaceutical companies worldwide. It provides powerful tools for clinical trials.
Pharma Consulting Group
Pharma Consulting Group (Uppsala, Sweden) was created in 2003 and began providing eCRF service in 2004.
Their system is now used throughout the world in more than 50 countries including in Europe, North America, Japan, New Zealand and Australia.
In Japan, more than 40 clinical trials and post-marketing surveillance projects have used Viedoc to deliver results in all clinical trial phases, post-marketing surveillances, and clinical trials for medical devices.
It provides powerful tools for clinical trials.
Pharma Consulting Group offers the following web-based solutions:
- Viedoc (eCRF service)
- ViedocMe (patient reported outcome [PRO])
- ViedocPMS (EDC system for post-marketing surveillance)
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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Auditing/Self-inspection
An independent reliability assurance department audits all of our GCP, GPSP, and GVP services.
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Clinical Development Support Services
Extensive achievements, knowledge, and advancement to support clinical trial projects
(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.
