Medical Writing
Experienced and reliable professionals quickly respond to your project needs in full compliance with regulations and guidelines
With guidance from professional medical writers, our vastly-experienced writing team provides various documents from applications and reexamination applications to preprints of scientific papers, all in compliance with guidelines.
Standard Operating Procedure
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*1 The number of reviews will be customized depending on the type of report, request, etc.
*2 The final draft is subjected to quality check by a third party.
Service Features
- Point 1.
- High-quality documents generated by experienced medical writers
- Point 2.
- Professional level of documents in English on drug development
Main Services with Details
GCP
We prepare the following draft documents:
- Clinical study report
- CTD (Common Technical Document)
- Research papers on clinical study results
- Protocol (draft)
- Subject informed consent (draft)
- Investigator’s brochure
PMS
We prepare the following draft documents:
- Periodic safety report
- Reexamination applications
- Post-marketing study papers
- Risk Management Plan (RMP)
- Protocol and implementation guidelines
- English translation of reports and applications
Cloud System “crossnote” Medical Writing Support Service
A comprehensive medical writing service utilizing cloud-based document writing support/management system
Using the cloud-based comprehensive documentation solution “crossnote,” we provide comprehensive support for effective, integrated and standardized medical writing services from the initial definition of requirements to system development and operation.
“crossnote” is a registered trademark of update it, inc.
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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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 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.
