SQN Health EDC
SQN Health EDC is an Electronic Data Capture system, used to collect data in clinical trials. The EDC deploys electronic Case Report Form's in both text and graphical form to collect the data and reports back through data visualisations in real time.
Features
- Rapid set up via validated, CDISC based eCRF modules
- Intuitive user interface
- Real-time data visualisation dashboards
- Multi language support
- Image/ video integration and graphical review
- Sophisticated, yet simple eCRFs
- Protocol amendments incorporated without system down-time
- Email and SMS alert capability based on study events
Benefits
- Entry via PC or Tablet
- Fully validated and audited by UK MHRA
- Integrated data collection, SDV, query, data management, investigator sign off
- Multi language support
- A Protected hosting facility part of the national infrastructure
- Database backups are taken every 15 minutes
Pricing
£70,000 to £350,000 an instance
Service documents
Request an accessible format
If you use assistive technology (such as a screen reader) and need versions of these documents in a more accessible format,
email the supplier at karen.grover@synequanon.com.
Tell them what format you need. It will help if you say what assistive technology you use.
Framework
G-Cloud 11
Service ID
6 9 9 7 5 9 0 7 8 8 5 4 7 0 6
Contact
SQN Clinical
Karen Grover
Telephone: 01379644449
Email: karen.grover@synequanon.com
Service scope
- Software add-on or extension
- Yes, but can also be used as a standalone service
- What software services is the service an extension to
- SQN Health EDC is part of the SQN Health umbrella which includes an electronic patient reported outcomes (ePRO) application and Medical coding suite.
- Cloud deployment model
- Private cloud
- Service constraints
- None
- System requirements
- None
User support
- Email or online ticketing support
- Email or online ticketing
- Support response times
- 1 Working Day
- User can manage status and priority of support tickets
- No
- Phone support
- Yes
- Phone support availability
- 24 hours, 7 days a week
- Web chat support
- Web chat
- Web chat support availability
- 24 hours, 7 days a week
- Web chat support accessibility standard
- None or don’t know
- How the web chat support is accessible
- Through the application utilising the users chosen text input device
- Web chat accessibility testing
- None
- Onsite support
- Yes, at extra cost
- Support levels
-
First line support is provided via web chat, email and telephone 24/7/365. Second line support is then issued by internal programming team via email or site support if required. Site support is costed accordingly.
Third line support is then escalated to the Senior project manager of the clinical study where this is dealt with based on business impact. - Support available to third parties
- Yes
Onboarding and offboarding
- Getting started
- Users are issued with interactive training and certification using a link provided by SQN.
- Service documentation
- Yes
- Documentation formats
-
- HTML
- End-of-contract data extraction
- Study data is extracted by either the SQN team who then packages and returns to the client and relevant clinical sites. Clients can also export data via the application using the 'data download' functionality. This can be extracted in a range of different formats.
- End-of-contract process
- All study generated documentation is returned to the client and subsequent study sites. The software login is then decommissioned which restricts access to the system.
Using the service
- Web browser interface
- Yes
- Supported browsers
-
- Internet Explorer 7
- Internet Explorer 8
- Internet Explorer 9
- Internet Explorer 10
- Internet Explorer 11
- Microsoft Edge
- Firefox
- Chrome
- Safari 9+
- Opera
- Application to install
- No
- Designed for use on mobile devices
- No
- Service interface
- No
- API
- No
- Customisation available
- Yes
- Description of customisation
- Customisations can be made through specifications defined within the clinical trials protocol. Customisations are then facilitated by members of the SQN team.
Scaling
- Independence of resources
- SLA's in place with the hosting service to ensure capacity. Real-time 24/7 monitoring.
Analytics
- Service usage metrics
- Yes
- Metrics types
- A list of site and users for a clinical trial is managed by SQN. These records are maintained using a Site User Access Tracker. This tracker collects site name, site number, User name, user role, user email. A live study audit trail then monitors the user's usage across the system. This can then be exported as a report upon request.
- Reporting types
- Reports on request
Resellers
- Supplier type
- Not a reseller
Staff security
- Staff security clearance
- Staff screening not performed
- Government security clearance
- None
Asset protection
- Knowledge of data storage and processing locations
- Yes
- Data storage and processing locations
- United Kingdom
- User control over data storage and processing locations
- No
- Datacentre security standards
- Managed by a third party
- Penetration testing frequency
- At least once a year
- Penetration testing approach
- Another external penetration testing organisation
- Protecting data at rest
-
- Physical access control, complying with another standard
- Encryption of all physical media
- Data sanitisation process
- Yes
- Data sanitisation type
- Deleted data can’t be directly accessed
- Equipment disposal approach
- A third-party destruction service
Data importing and exporting
- Data export approach
- Users can export the data through the software application. Additionally, the data is displayed within the system using data visualisations. these data visualisations can be saved as reports in a variety of formats or reviewed on the dashboard itself.
- Data export formats
-
- CSV
- Other
- Other data export formats
-
- XML
- SAS
- Data import formats
-
- CSV
- Other
- Other data import formats
-
- XML
- Any data type with appropriate data transfer specifications
- Image and video upload in the common formats
- Medical imaging formats
Data-in-transit protection
- Data protection between buyer and supplier networks
-
- Private network or public sector network
- IPsec or TLS VPN gateway
- Data protection within supplier network
-
- TLS (version 1.2 or above)
- IPsec or TLS VPN gateway
- Legacy SSL and TLS (under version 1.2)
Availability and resilience
- Guaranteed availability
- We have SLAs in place with our hosting provider Piksel to ensure a minimum service level of 99.0%. However, the target service level is 99.95%. Any downtime is considered as a high priority and target response times to fix the issue is determined at <30 minutes.
- Approach to resilience
- Information is as per our SLA's and available on request.
- Outage reporting
- Service outages are monitored 24/7 by our hosting provider as set out with our SLAs agreement. This is also monitored 24/7 by our in house IT support team with email alerts in place for the escalation procedure.
Identity and authentication
- User authentication needed
- Yes
- User authentication
-
- Username or password
- Other
- Other user authentication
-
Multi level, one additional piece of information required with rules around the password.
Further, users are required to re-authenticate at intervals. - Access restrictions in management interfaces and support channels
- Username and password and one other controlled.
- Access restriction testing frequency
- Less than once a year
- Management access authentication
-
- Dedicated link (for example VPN)
- Username or password
Audit information for users
- Access to user activity audit information
- Users have access to real-time audit information
- How long user audit data is stored for
- At least 12 months
- Access to supplier activity audit information
- Users contact the support team to get audit information
- How long supplier audit data is stored for
- At least 12 months
- How long system logs are stored for
- At least 12 months
Standards and certifications
- ISO/IEC 27001 certification
- No
- ISO 28000:2007 certification
- No
- CSA STAR certification
- No
- PCI certification
- No
- Other security certifications
- No
Security governance
- Named board-level person responsible for service security
- Yes
- Security governance certified
- No
- Security governance approach
- SQN manages security through a quality management system. This dictates that SQN must follow processes as per standard SOPs and policies.
- Information security policies and processes
- Internal quality management system and internal QA department.
Operational security
- Configuration and change management standard
- Supplier-defined controls
- Configuration and change management approach
-
Configuration of the system will be performed every two years. A periodic assessment of the system takes place to ensure the system still complies with the initial validation. All assessments and reviews are documented as per SOPs.
A change control request is made and forwarded to evaluates whether the change control is appropriate. An Impact, change and risk will be made to allow the change control board to have all the information to make a decision. The change control board will review and authorise the implementation of change. Changes are implemented and controlled against the computer systems validation SOPs. - Vulnerability management type
- Supplier-defined controls
- Vulnerability management approach
- Managed by our host partner as part of the SLA's. SQN receive notification via email about patches which are going to be applied and this is confirmed by SQN. Security patches are tested and then applied automatically.
- Protective monitoring type
- Supplier-defined controls
- Protective monitoring approach
- Managed by our host partner as part of the SLA's. SQN receive a notification via email about any incidents which occur.
- Incident management type
- Supplier-defined controls
- Incident management approach
- Incidents are managed by both our hosting partner Piksel and SQN via an escalation process and facilitated as part of our SLAs agreement. A ticket system will be provided via our hosting partner. If the incident cannot be resolved this is then escalated to the SQN team as a second line of support. A governance process is then in a place where escalation occurs up within the organisation. The process is documented and an incident report is produced one mitigated and archived.
Secure development
- Approach to secure software development best practice
- Conforms to a recognised standard, but self-assessed
Public sector networks
- Connection to public sector networks
- No
Pricing
- Price
- £70,000 to £350,000 an instance
- Discount for educational organisations
- No
- Free trial available
- No
Service documents
Request an accessible format
If you use assistive technology (such as a screen reader) and need versions of these documents in a more accessible format,
email the supplier at karen.grover@synequanon.com.
Tell them what format you need. It will help if you say what assistive technology you use.