SQN Clinical

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

£70000 to £350000 per instance

Service documents

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

01379644449

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
  • PDF
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
  • PDF
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
£70000 to £350000 per instance
Discount for educational organisations
No
Free trial available
No

Service documents

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