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 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.
