PMS Support Services
ALL Remote PMS Full Support Service
From beginning to end of post-marketing surveillance
We offer a wide variety of services that go beyond the framework of existing CRO services.
We support your post-marketing surveillance at every stage.
Our service of post-marketing surveillance is more than the conventional CRO services such as patient registration, data management and biostatistics. We are fully equipped to provide support for study planning and reexamination applications in addition to administrative tasks. We respond promptly and precisely to the various PMS issues facing our clients.
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Service Features
- Point 1.
- Provide “full support service” from planning of study to construction and operation
- Point 2.
- Free from MR visits, support for introduction of remote method
- Point 3.
- Support distribution management and handle delivery control and all-patient surveillance
Main Services with Details
Study planning
- Implementation guidance and protocol drafts preparation
- CRFs and registration card preparation
- Study planning consultation
- PMS planning support
PMS monitoring
- Conclusion of contracts with sites across the country, CRF collection, query management
- Progress management
PMS call center
- Help desk for MRs
- Help desk for medical institutions
Regulatory affairs support
- Periodic safety reporting drafts, PSUR and DSUR preparation
- Draft materials for reexamination applications
- Conformity audit support
Distribution management support
- Real-time web system notification to confirm requirements and unlock for delivery
- Progress management on contract and registration of all-patient surveillance
- Registration of sites and investigators requirements
- Delivery notice receipt
- Help desk via telephone
Related Service
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Patient Registration
High-quality and speedy PMS patient registration center service based on our extensive experience.
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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.
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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.
(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.
