Our Services
The future of data collection
Starsphere K.K. is a life sciences company.
Starsphere is committed to assisting in data collection and analysis activities.
■ DokodemoForm ® EDC
■ ePRO (Coming soon)
■ Questionnaire system (Coming soon)
■ Pharmacovigilance Service Areas of Expertise
・System Implementation and Project Management
・ Risk-based Computer System Validation
21 CFR Part 11, Gamp 5
・ Periodic Regulatory Reporting
PMDA
・ Custom Reporting
・ Data Analysis and Cleansing
・ Training
・ Data Migration
Please contact us from the button below for document requests and inquiries.
Clinical Research EDC System
"DokodemoForm® EDC "
Subscription
DokodemoForms® IIS
Version 2.1
release
A new plan for DokodemoForm® EDC, "Dokodemo- Form® IIS". Why not try out our secure and convenient EDC?
No initial cost
・Subscriptions do not require expensive initial costs. You can start anytime, anywhere.
Customizable
- Easily customize items by clicking and dragging.
Free cancellation
- Pay only for what you use . You can stop using the system at any time .
Security and Privacy Protection
・EDC functions remain the same. You can also use the latest v2.1.
- New features implemented based on customer feedback -
・Download all survey forms in PDF format
・Download list of queries
・Download list of subjects by facility
-Subject registration number change/deletion function
Quick & Easy
Security and Compliance
Shortest setting
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EDC for clinical trials will be prepared in no time with simple drop and drag settings. The system development period and validation support period can be significantly shortened.
Screen specialized for user-friendliness
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Not only can it be used intuitively, but the input form for logical check and consistency check of the input value is also created based on the user's voice, so even the first person can easily start registration.
Ubiquitous cloud base
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Since it is cloud-based, it can be used from anywhere and the collaboration of participating users is also real-time.
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Not only can you use Windows and Mac, but it also supports input on tablets as well as PCs.
Compliance with laws and regulations
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Compatible with GCP, GPSP and 21CFR part 11 ISO / IEC 27001: 2005 Audit
Safe and secure encryption security
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Connections to Form® EDC everywhere are encrypted through SSL technology . In addition, all data is stored in a fully encrypted database so that only authorized users can access the database.
Disaster recovery
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The database that stores clinical data can be continuously replicated at specific locations and can be restored at any time for 7 days.
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Clinical data is replicated in real time. It is then replicated in real time to a data center elsewhere. In the unlikely event of a disaster, your clinical data will be available in a data center elsewhere that is not affected by the disaster.
- Backups are done daily.
Facility user
Data entry (eCRF, log form, etc)
Electronic signature
Query management
Clinical review
Data review
Data lock
Data output (CSV, Excel, PDF)
file upload
Alert email
Dynamic allocation
Static allocation
Automatic numbering (manual, automatic)
Subject Progress Report Matrix
(Subject / Query status, Progress management, etc)
Adverse event
Unplanned visit
Audit Trail
Payment management
Management function
Protocol Progress Report Facility
Contract management data import
Permission setting
Role user account settings management
Audit Trail
Payment management
others
Japanese-English correspondence
Help desk support
Validation
Other Services
Global IT Consultation
Data Analysis
We provide IT consulting and system development for global pharmaceutical companies in Japanese and English.
Pharmacovigilance Service Areas of Expertise
・System Implementation and Project Management
・ Risk-based Computer System Validation
21 CFR Part 11, Gamp 5
・ Periodic Regulatory Reporting
PMDA
・ Custom Reporting
・ Data Analysis and Cleansing
・ Training
・ Data Migration
If you wish, please feel free to contact us using the contact form.
We use Microsoft Power BI, Excel macros, etc. to cleanse, visualize, and migrate data within pharmaceutical companies.
If you wish, please feel free to contact us using the contact form.