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

£4,440 to £44,000 a licence a year

• Education pricing available
• Free trial available

Service documents

• Pricing document

  PDF

• Service definition document

  PDF

• Terms and conditions

  PDF

• Modern Slavery statement

  PDF

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 martin.elenkov@bgosoftware.com. Tell them what format you need. It will help if you say what assistive technology you use.

Framework

G-Cloud 13

Service ID

887202644055919

Contact

Martin Elenkov
+359 894 481 089
martin.elenkov@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: Chrome
• 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
• User support accessibility: WCAG 2.1 AA or EN 301 549
• 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: Conforms to BS7858:2019
• Government security clearance: None

Asset protection

• Knowledge of data storage and processing locations: Yes
• Data storage and processing locations: European Economic Area (EEA)
• User control over data storage and processing locations: Yes
• 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: Yes
• Who accredited the ISO/IEC 27001: ALBERK QA TECHNIC CORP.
• ISO/IEC 27001 accreditation date: 06/03/2020
• What the ISO/IEC 27001 doesn’t cover: Everything is covered.
• ISO 28000:2007 certification: No
• CSA STAR certification: No
• PCI certification: No
• Cyber essentials: Yes
• Cyber essentials plus: Yes
• Other security certifications: Yes
• Any other security certifications: ISO 9001:2015

Security governance

• Named board-level person responsible for service security: Yes
• Security governance certified: Yes
• Security governance standards:
  • ISO/IEC 27001
  • Other
• Other security governance standards: ISO 9001; ISO/IEC 27001:2005
• 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

Social Value

• Covid-19 recovery:

  Covid-19 recovery

  Clinicubes is a system that digitalise the Clinical Research management, which is of an essential matter, when creating a vaccine or medicine against Covid 19.

Pricing

• Price: £4,440 to £44,000 a licence a year
• Discount for educational organisations: Yes
• Free trial available: Yes
• Description of free trial: Full system access for 10 working days.

Service documents

• Pricing document

  PDF

• Service definition document

  PDF

• Terms and conditions

  PDF

• Modern Slavery statement

  PDF

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 martin.elenkov@bgosoftware.com. Tell them what format you need. It will help if you say what assistive technology you use.