BGO SOFTWARE OOD

Clinicubes CTMS

Clinicubes CTMS is a centralized software (clinical trial management system), which offers a number of benefits to companies in the clinical research industry in the form of integrated solutions for every single aspect and phase of clinical studies. Our product makes processes behind various planning, performing and reporting tasks easier.

Features

  • Overview and management of clinical trials
  • Study events and activities management
  • Study contracts, budgeting, invoices, payments and financial forecasting
  • Site management and regulatory process tracking
  • Subjects database and study enrollment tracking
  • Physicians, health service institutions and study performance datadatabase
  • Project documents collection and tracking
  • Dynamic dashboards with key metrics
  • Alerts and reporting. Calendar scheduling features
  • Workflows. Milestone tracking. Tasks management.

Benefits

  • Overview clinical trials objectives, timetables, phases
  • Manage study events and activities
  • Track key information related to protocol requirements, monitoring frequency
  • Prepare study contracts, carry out financial forecasting, quickly do budgeting
  • Facilitates site identification and recruitment
  • Enables research professionals to monitor sites and regulatory processes
  • Aggregate, systematize and reorganize physicians and healthcare service institutions database
  • Collect, evaluate, analyze data from multiple studies and different locations
  • Communicate study performance data and operational reports trough interactive dashboards
  • Provide reporting options of how the trial is being carried

Pricing

£4440 to £44000 per licence per year

  • Education pricing available
  • Free trial available

Service documents

Framework

G-Cloud 11

Service ID

9 0 3 5 5 3 1 0 3 6 5 3 4 5 2

Contact

BGO SOFTWARE OOD

Ivan Lekushev

359888606559

ivan@bgosoftware.com

Service scope

Software add-on or extension
No
Cloud deployment model
  • Public cloud
  • Private cloud
  • Community cloud
  • Hybrid cloud
Service constraints
No, it doesn't.
System requirements
  • Microsoft Windows Server OS
  • Microsoft .NET Framework 4.5 or newer
  • Microsoft SQL Server 2012 or newer
  • Hardware: 2 CPU cores, 8GB RAM

User support

Email or online ticketing support
Email or online ticketing
Support response times
The SLA for urgent tickets is less than 1 hour during working days. We also offer phone support out of work hours and weekends at extra cost.
User can manage status and priority of support tickets
Yes
Online ticketing support accessibility
WCAG 2.1 AA or EN 301 549
Phone support
Yes
Phone support availability
24 hours, 7 days a week
Web chat support
Web chat
Web chat support availability
9 to 5 (UK time), Monday to Friday
Web chat support accessibility standard
WCAG 2.1 AA or EN 301 549
Web chat accessibility testing
Screen reader testing and also screen magnification software.
Onsite support
Yes, at extra cost
Support levels
We provide 2 levels of support:

Standard:
Includes 24/7 tickets, working hours phone support, 20 hours per year free development and customization support for building reports and customizing the software.

Gold:
Dedicated account manager, dedicated cloud support engineer, 24/7 tickets, working hours phone support, 40 hours per year free development and customization support for building reports and customizing the software. 1 day reaction to start building customized reports and data extracts.
Support available to third parties
Yes

Onboarding and offboarding

Getting started
We provide online training and manuals. We can also provide onsite training.
Service documentation
Yes
Documentation formats
  • HTML
  • PDF
End-of-contract data extraction
Users would receive the data in a common format - Excel, CSV etc. The data can be provided as SQL server backup file as well.
End-of-contract process
Usually there is an exit plan strategy negotiated and provided at the beginning of the contract. That can vary depending on the customer needs. All the data belongs to the customer so the minimum is that the data is provided as a SQL Server backup file with a protocol of receipt at the end of the contract.

Using the service

Web browser interface
Yes
Supported browsers
  • Internet Explorer 9
  • Internet Explorer 10
  • 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
The system layout is auto-adapted for smaller screens when a mobile device is detected. Some of the features are not accessible when using mobile phones. All features are available for tablets - 7" and above.
Service interface
Yes
Description of service interface
There is a web based admin console which allows the users to modify and maintain certain aspects of the platform.
Accessibility standards
WCAG 2.1 AA or EN 301 549
Accessibility testing
Screen magnification tools and screen readers.
API
Yes
What users can and can't do using the API
The service has an API which offers the full capabilities for storing and fetching data. All types of records can be manipulated using it.
API documentation
Yes
API documentation formats
  • HTML
  • PDF
API sandbox or test environment
Yes
Customisation available
Yes
Description of customisation
Clinicubes is a customizable clinical trial management system, based on a "vanilla" type of software. The latter can be specifically tailored to the needs of the buyer. Possible changes that could be made include: reporting, activities, dashboard settings and etc. Users can customize procedures, activities and costs. By contacting us and with our support, users can chose which feature in the system they want to be changed.

Scaling

Independence of resources
We could provide separate database or separation in the same database using unique identifiers

Analytics

Service usage metrics
Yes
Metrics types
Clinicubes CTMS can: overview clinical trials objectives, timetables, phases, etc.; manage study events, activities and milestone tracking; track key information related to adherence to protocol requirements, monitoring frequency, collection of care report forms (CRFs) and more; prepare study contracts, carry out financial forecasting, quickly do budgeting, send and receive invoices, ensure billing complaints, track study costs, set up secure payments and keep them in check; track subject enrollment and subjects database; aggregate, systematize and reorganize physicians and healthcare service institutions database; analyze data from multiple studies and different locations on a single report
Reporting types
Real-time dashboards

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
Other locations
User control over data storage and processing locations
No
Datacentre security standards
Supplier-defined controls
Penetration testing frequency
At least every 6 months
Penetration testing approach
Another external penetration testing organisation
Protecting data at rest
Physical access control, complying with another standard
Data sanitisation process
Yes
Data sanitisation type
  • Explicit overwriting of storage before reallocation
  • Deleted data can’t be directly accessed
Equipment disposal approach
A third-party destruction service

Data importing and exporting

Data export approach
All the tables displayed by the system have an export option. In addition custom (tailored) data exports are provided as an additional service.
Data export formats
  • CSV
  • Other
Other data export formats
  • PDF
  • CSV
  • RTF
Data import formats
CSV

Data-in-transit protection

Data protection between buyer and supplier networks
  • Private network or public sector network
  • TLS (version 1.2 or above)
  • IPsec or TLS VPN gateway
Data protection within supplier network
  • TLS (version 1.2 or above)
  • IPsec or TLS VPN gateway

Availability and resilience

Guaranteed availability
The guaranteed availability according to our SLA is 99.95%
If there is less availability the customer is compensated by deducting the proportional amounts from the monthly bill.
Approach to resilience
Our service runs on VMWare high availability clusters. Each node has two identical physical servers for redundancy. There is a SAN storage network with high availability power supply and RAID 10 arrays. At least two alternative network routes are used per node.
Outage reporting
Email alerts and support tickets.

Identity and authentication

User authentication needed
Yes
User authentication
Username or password
Access restrictions in management interfaces and support channels
User management, user roles and admin
Access restriction testing frequency
At least every 6 months
Management access authentication
  • 2-factor authentication
  • Public key authentication (including by TLS client certificate)
  • Identity federation with existing provider (for example Google Apps)
  • Limited access network (for example PSN)
  • Dedicated link (for example VPN)
  • Username or password

Audit information for users

Access to user activity audit information
Users contact the support team to get 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
Yes
Any other security certifications
ISO 27001 pending

Security governance

Named board-level person responsible for service security
Yes
Security governance certified
Yes
Security governance standards
Other
Other security governance standards
IEC 27001 pending
Information security policies and processes
IEC 27001 and GDPR.

Operational security

Configuration and change management standard
Supplier-defined controls
Configuration and change management approach
We follow ITIL practices.
Vulnerability management type
Supplier-defined controls
Vulnerability management approach
Security patches are deployed in 2-3 hours after detection.
There is quarterly security scan done by third party.
Protective monitoring type
Supplier-defined controls
Protective monitoring approach
We schedule quarterly security scans and use the reports by our security assessment provider. High-impact patches are applied immediately.
Incident management type
Supplier-defined controls
Incident management approach
The incidents are stored in our internal system - JIRA. They are escalated to the relevant team - network engineering, hardware or software development (R&D).

Secure development

Approach to secure software development best practice
Supplier-defined process

Public sector networks

Connection to public sector networks
No

Pricing

Price
£4440 to £44000 per licence per year
Discount for educational organisations
Yes
Free trial available
Yes
Description of free trial
Full system access for 10 working days.

Service documents

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