Kephala Share is a cloud platform that allows for the global tracking, transfer and storage of large files, especially those that contain sensitive clinical data. While our core expertise has been in large (> 100 GB) video EEG files, Kephala Share can manage any file type of any size.
​
The system is specifically designed for use in clinical trials
-
Kephala is certified to ISO 27001 for information security management, and ISO 9001 for quality management.
-
Complies with privacy and health-related regulations for managing clinical data including 21 CFR 11, ICH -GCP, GDPR and HIPAA
Key Features
Kephala Share supports the uploading of clinical data in multiple file formats.
-
The system supports uploading and downloading files (100+ Gigabytes) from a standard web browser. All files are stored securely in the Cloud.
-
No software installation is required to upload or download files. All stored files are encrypted using AES 256 bit encryption while stored on the platform.
-
The system is fully redundant, running across multiple data centres to ensure high availability and reliability.
-
The system supports the uploading of files from multiple sites by predefined users. There are three types :
-
Users - can only upload files
-
Readers - can only access uploaded files and download them for review
-
Study Admins - can create and track users and sites against studies
-
-
A long-term storage option is available for customers who require archival for compliance purposes.
User Feature Table
Kephala Share | Study Admin's View
-
Study Admins (CRO and/or Sponsor):
-
Can create sites and users against selected studies
-
Can track and monitor the status of the:
-
Generates customised Reports
-
Configurable to the specific study protocol
Kephala Share | Reader's View
-
Can only access the Subject file screen
-
Are the only users of the system to have access to download a file
-
Are provided with a secure AWS workspace to download, read and annotate files
-
Configurable text to reflect specific study protocol
Kephala Share | User's View
User’s (Clinical Site):
-
Can only access the ‘Upload file’ screen
-
Can only see study details they have been assigned to
-
Tracking available on relevant training material uploaded - Time viewed and % viewed
-
Configurable screens to reflect specific study protocol
Kephala Share Support
We offer a comprehensive support package for both the administrators and the users of Kephala Share:
-
24/7 Technical support for all of our users
-
Provision of country-specific toll-free support numbers on request
-
Study Admin training days on set up
-
Upload of specific training documents to the Training Portal of the user profile