Datatrial Ltd

Nucleus

Nucleus provides a cost effective hub for clinical information (documents, communication, and technologies) to enhance collaboration and decision making. Built for the compliant clinical research environment, it can be deployed simply to enable more efficient access to information and other third party technology

Features

  • Compliant Document Repository
  • Collaboration and workflows
  • Permission management and audit trail enabled
  • Multi program management
  • Instant messaging
  • Single sign on and application management
  • Two factor authentication

Benefits

  • All documents and data in a compliant environment
  • Information/people can be grouped to improve ease of access
  • Enhanced security can be enabled to protect sensitive data
  • Access the latest version of documents (inbuilt document version control)
  • Improved communication via instant messaging and document sharing
  • Access multiple applications with or without single sign on
  • Initiate/manage workflows for document reviews or tasks

Pricing

£25 a person a month

  • Education pricing available
  • Free trial available

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 julie.wright@datatrial.com. Tell them what format you need. It will help if you say what assistive technology you use.

Framework

G-Cloud 12

Service ID

4 7 4 5 0 8 4 1 2 1 8 7 8 2 0

Contact

Datatrial Ltd Julie Wright
Telephone: 0191 2128200
Email: julie.wright@datatrial.com

Service scope

Software add-on or extension
No
Cloud deployment model
Private cloud
Service constraints
None
System requirements
  • Internet Explorer 11
  • Microsoft edge
  • Firefox v58 or later
  • Chrome v64 or later
  • Safari v11

User support

Email or online ticketing support
Email or online ticketing
Support response times
Response Times: Business Critical Failures one (1) Business Hour by a support consultant. System Defect with Workaround two (2) Business Hours. Minor Error acknowledgement of receipt of the support request within three (3) business hours. Support desk availability 9am to 5pm (Uk Time) Mon-Fri (ex Bank Holidays) by direct telephone, Email support and Online logging of issues.
User can manage status and priority of support tickets
No
Phone support
Yes
Phone support availability
9 to 5 (UK time), Monday to Friday
Web chat support
No
Onsite support
Yes, at extra cost
Support levels
Datatrial Help Desk Services encompass: Telephone support Email support Online logging of issues with tracking
We offer the following response and resolution times:

Priority 1: Business Critical Failures: An error in, or failure of, the Products/Services that: a) materially impacts the operations of the Customer’s business or reliability of its service or product; b) prevents necessary work from being done; or c) disables major functions of the Products from being performed – response within 1 (one) business hour, resolve within one (1) Business Day

Priority 2: System Defect with Workaround: a) a critical error in the Products for which a work-around exists; or b) a non-critical error in the Products that affects the operations of the Customer’s business or marketability of its service or product – response within 2 (two) business hours, resolve within two (2) Business Days

Priority 3: Minor Error: an isolated or minor error in the Products that: a) does not significantly affect Products functionality; may disable only certain non-essential functions; or c) does not materially impact the Customer’s business performance.
Support available to third parties
No

Onboarding and offboarding

Getting started
To support customers use the service we offer a training programme which can tailored for the customer’s needs and can be delivered onsite, here at Datatrial, at customer site or via webex

Training documentation is provided and can be tailored to reflect the customers unique set-up.

A telephone support service is available free of charge to those who have attended the training programme.
Service documentation
Yes
Documentation formats
  • HTML
  • PDF
End-of-contract data extraction
Data can be extracted by the customer themselves.
End-of-contract process
Included within the price of the contract will be the decommissioning of all services.

Using the service

Web browser interface
Yes
Supported browsers
  • Internet Explorer 11
  • Microsoft Edge
  • Firefox
  • Chrome
  • Safari 9+
Application to install
No
Designed for use on mobile devices
Yes
Differences between the mobile and desktop service
All interfaces within the application are accessible on tablet and mobile devices. There is no functionality difference between mobile and desktop clients.
Service interface
No
API
Yes
What users can and can't do using the API
An OAuth 2.0 compliant API is available to allow third party application login and registration into the Nucleus framework.

Customers can add their own application URLs to provide fast access to systems outside of the Nucleus framework.

Set-up and access to the API's can be arranged by Datatrial Support
API documentation
Yes
API documentation formats
Other
API sandbox or test environment
Yes
Customisation available
Yes
Description of customisation
On Request

Scaling

Independence of resources
Datatrial guarantee that our hosted Nucleus service will be available 99.95% of the time, backed by Microsoft Azure Service Level Agreements.

Analytics

Service usage metrics
Yes
Metrics types
Using tools such as web analytics and other data sources Datatrial’s Customer Success team monitors and measures service performance and usage to recommend where improvements to the service can be made .

These recommendations are reviewed with our customers to determine options for continued improvement.
Reporting types
Regular reports

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
Supplier-defined controls
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 CSA CCM v3.0
  • Physical access control, complying with SSAE-16 / ISAE 3402
  • Other
Other data at rest protection approach
All client data is encrypted at rest and in transit.
Data sanitisation process
No
Equipment disposal approach
A third-party destruction service

Data importing and exporting

Data export approach
Data is exported by the customer themselves
Data export formats
Other
Other data export formats
Data is exported in the same format as uploaded
Data import formats
Other
Other data import formats
No bulk data import (other than files in folders) available.

Data-in-transit protection

Data protection between buyer and supplier networks
Other
Other protection between networks
All client data is encrypted at rest and in transit.
Data protection within supplier network
Other
Other protection within supplier network
Physical access control, complying with CSA CCM v3.0
Physical access control, complying with SSAE-16 / ISAE 3402

Availability and resilience

Guaranteed availability
Datatrial guarantee that our hosted Nucleus service will be available 99.95% of the time, backed by Microsoft Azure
Service Level Agreements.
We acknowledge that if the service levels fall below the quality we commit to then penalties will be incurred to
compensate clients and drive service improvement.
Financial penalties and service credits and their calculation will be agreed as part of the call-off agreement with the
specific customer together with the terms and conditions and KPIs for the service.
Approach to resilience
Available on request
Outage reporting
Email alerts

Identity and authentication

User authentication needed
Yes
User authentication
  • 2-factor authentication
  • Other
Other user authentication
Email / password combination
Access restrictions in management interfaces and support channels
Available via permission settings and down to file level
Access restriction testing frequency
Never
Management access authentication
Other
Description of management access authentication
Limited access via Azure Management Portal

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
User-defined
Access to supplier activity audit information
Users have access to real-time audit information
How long supplier audit data is stored for
User-defined
How long system logs are stored for
User-defined

Standards and certifications

ISO/IEC 27001 certification
No
ISO 28000:2007 certification
No
CSA STAR certification
No
PCI certification
No
Other security certifications
Yes
Any other security certifications
21CFR Part 11 Compliant

Security governance

Named board-level person responsible for service security
Yes
Security governance certified
No
Security governance approach
Datatrial operate with a comprehensive Quality Management System.
Information security policies and processes
It is the policy of Datatrial Limited to ensure that Information will be protected from a loss of:
Confidentiality: so that information is accessible only to authorised individuals.
Integrity: safeguarding the accuracy and completeness of information and processing methods.
Availability: that authorised users have access to relevant information when required.
The Quality Manager reviews and makes recommendations on the Standard Operating Procedures relating to
Information Technology, Backup and Logical Access and Security.
Regulatory, legislative and contractual requirements are incorporated into the Information Technology processes and procedures

Operational security

Configuration and change management standard
Supplier-defined controls
Configuration and change management approach
Change management processes are employed to evaluate, control and minimise risks and costs, and to maintain the
standards and quality criteria planned during project delivery
Extensive documentation of the service is maintained to ensure knowledge sharing and continuity of service.
Datatrial employs a self-documenting approach to writing code and supplements this, where appropriate, with technical
and user guides.
We do this in order to ensure that skills and knowledge are transferred to Datatrial’s development, deployment and
support staff to enable them to efficiently deliver ongoing support and maintenance services, in accordance with agreed SLAs.
Vulnerability management type
Supplier-defined controls
Vulnerability management approach
Vulnerability management is handled by the Microsoft, who host the SaaS Web Application and Database Service.
Protective monitoring type
Supplier-defined controls
Protective monitoring approach
We use 3rd party 'always-on' site monitoring services to detect any potential issues with service. We respond within 1hr
to urgent issues.
Incident management type
Supplier-defined controls
Incident management approach
Datatrial has a pre-defined process for managing common incident events.
All suspected security events are reported to the Head of Software Development by email, telephone or in person.
The Head of Software Development will log the incident and notify the service owner and Datatrial support team.
The Head of Software Development will provide incident reports in line with incident communication strategy

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
£25 a person a month
Discount for educational organisations
Yes
Free trial available
Yes
Description of free trial
A free trial service is available for a period of three months to evaluate the service. Up to five user accounts are available to support the free trial evaluation.

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 julie.wright@datatrial.com. Tell them what format you need. It will help if you say what assistive technology you use.