BGO SOFTWARE

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

G-Cloud 10

626750162701429

BGO SOFTWARE

Ivan Lekushev

359888606559

ivan@bgosoftware.com

Service scope

Service scope
Software add-on or extension No
Cloud deployment model Private 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

User support
Email or online ticketing support Email or online ticketing
Support response times Depends on the SLA agreement, from 15 minutes up to an hour
User can manage status and priority of support tickets Yes
Online ticketing support accessibility None or don’t know
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), 7 days a week
Web chat support accessibility standard None or don’t know
How the web chat support is accessible It is accessible viа the web site: www.clinicubes.com
Web chat accessibility testing We are using this web chat system for a few other website of ours and it works very well in real scenarios.
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

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

Using the service
Web browser interface Yes
Supported browsers
  • Internet Explorer 10
  • Internet Explorer 11
  • Microsoft Edge
  • Firefox
  • Chrome
  • Safari 9+
  • Opera
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.
Accessibility standards None or don’t know
Description of accessibility The system is a web based software as a service (SaaS). It is hosted in the cloud and accessed via SSL protected URL using a web browser. The service is adapted to users with special needs it has relatively large buttons and fonts which can be adjusted additionally, complies with the browser zooming capabilities and has responsive design which adapts to different screen sizes.
Accessibility testing The system works well with screen reader plugins (voice to text).
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

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

Analytics

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

Resellers
Supplier type Not a reseller

Staff security

Staff security
Staff security clearance Staff screening not performed
Government security clearance None

Asset protection

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 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-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

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

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 Username or password

Audit information for users

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

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

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

Operational security

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

Secure development
Approach to secure software development best practice Supplier-defined process

Public sector networks

Public sector networks
Connection to public sector networks No

Pricing

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.

Documents

Documents
Pricing document View uploaded document
Service definition document View uploaded document
Terms and conditions document View uploaded document
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