Our Services
データ収集の未来へ
Starsphere K.K. is a life sciences company.
Starsphere is committed to assisting in data collection and analysis activities.
■ Dokodemo Form ® 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.
どこでもフォーム®EDC
Subscription
Version 2.1
release
どこでもフォーム®EDCの新プラン 「サブスクリプション」。セキュアで便利なEDCを気軽に試してみませんか？
初期費用不要
・サブスクリプションは高価な初期費用が不要。いつでも気軽に始められます。
カスタマイズ可能
・自らクリック＆ドラックで項目を簡単カスタマイズ。
キャンセル自由
・使った分だけお支払い。いつでもシステムの利用を停止することが出来ます。
セキュリティとプライバシー保護
・EDCの機能はそのまま。最新のv2.1もご利用できます。
初月サポート無料*
＊2023年度中のご契約にかぎり詳しくはお問合せください
- お客様の声を反映した新機能搭載 -
・全調査票PDF一括ダウンロード
・クエリー一覧ダウンロード
・施設毎 被験者一覧ダウンロード
・被験者登録番号の変更 / 削除機能
Quick ＆Easy
Security and Compliance
Shortest setting
-
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
-
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
-
Since it is cloud-based, it can be used from anywhere and the collaboration of participating users is also real-time.
-
Not only can you use Windows and Mac, but it also supports input on tablets as well as PCs.
Compliance with laws and regulations
-
Compatible with GCP, GPSP and 21CFR part 11 ISO / IEC 27001: 2005 Audit
Safe and secure encryption security
-
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
-
The database that stores clinical data can be continuously replicated at specific locations and can be restored at any time for 7 days.
-
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.