Infonetica Ltd

Clinical Trial Data Management System

ReDA is a Cloud-based Clinical Trial Management System (CTMS) used by research hospitals, research-intensive universities and government bodies.
Its scalable architecture allows for single-site, multi-site and multi-tenanted organisational set-ups. It is a Local Portfolio Management System (LPMS) and research data management platform for Local Clinical Research Networks (LCRNs).

Features

• Clinical study management
• Participant & Recruitment management
• Research site management
• Research governance
• Participant personally identifiable information data management (GDPR compliant)
• Standard Operating Procedures (SOPs) & Contracts store
• Sponsors & funder management
• Finance & cost management
• Usage audits
• Reporting

Benefits

• Overview of clinical study statuses and clinical trial portfolio
• Simplify project feasibility assessment & manage expression of interests (EOI)
• Minimise study set-up times
• Efficiently manage recruitment targets and study arms
• Monitor and manage governance requirements
• Efficiently manage participants, treatments and costs
• Provide data access based on permissions
• Report on study and portfolio performance
• Access platform through web interface

£10,000 to £45,000 a licence a year

• Education pricing available

Service documents

• Pricing document

  PDF

• Service definition document

  PDF

• Terms and conditions

  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 Russell.Pridmore@infonetica.net. Tell them what format you need. It will help if you say what assistive technology you use.

Framework

G-Cloud 14

Service ID

919689781507125

Contact

Russell Pridmore
0208 334 6900
Russell.Pridmore@infonetica.net

Service scope

• Software add-on or extension: No
• Cloud deployment model: Private cloud
• Service constraints: No.
• System requirements:
  • Internet
  • Web browser

User support

• Email or online ticketing support: Email or online ticketing
• Support response times: Tickets are classified into 4 groups depending on the nature of a ticket and the severity of the incident. The response rate is dependent on the severity. A table detailing response rates and escalation routes is included in the contract.
• 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: We provide training to system administrators to build forms and workflows as well as to manage and use the system. These training sessions are provided at the start of the service and subsequently additional days are available on a needs basis at a cost of £1,100 per day. The system is very intuitive such that historically users have not needed any training to use the system. In addition, we offer telephone, email and support via an Online Jira platform for any system related queries or issues. Clients would also have a single point of technical contact as further support.; In addition, we offer telephone, email and support via an Online Jira platform for any system related queries or issues. ; Clients would also have a single point of technical contact as further support.
• Support available to third parties: Yes

Onboarding and offboarding

• Getting started: We support the system administrators to set up the system for optimal use. We also provide onsite or web-based training for system administrators and key users to use the system based on their roles. For large multi-site / multi-tenanted organisations, we provide train-the-trainer sessions. We provide user documentation as well.
• Service documentation: Yes
• Documentation formats: Other
• Other documentation formats: Word Documents
• End-of-contract data extraction: All data can be extracted via the reporting, we also provide a standardised data extract service where we provide existing data in a standard excel format.
• End-of-contract process: An extract of customer data in our suggested format in the timescales provided in the contract is included in the price of the contract. Any change to format (where possible) and timescales incur an additional cost.

Using the service

• Web browser interface: Yes
• Supported browsers:
  • Microsoft Edge
  • Firefox
  • Chrome
• Application to install: No
• Designed for use on mobile devices: Yes
• Differences between the mobile and desktop service: None
• Service interface: No
• User support accessibility: WCAG 2.1 AA or EN 301 549
• API: Yes
• What users can and can't do using the API: Users can submit data via the API to make updates to the system by submitting a JSON request to ReDA.
• API documentation: Yes
• API documentation formats: Other
• API sandbox or test environment: Yes
• Customisation available: Yes
• Description of customisation: Users can change: Field Names, Field Visibility, Section Names, Section Visibility, drop-down values.; Users can add also additional fields and sections; ; Administrators are the only user type that can change how the core system operates/functions. E.g. Add additional fields or sections.; ; All users have the ability to change areas based on personal preference such as the search settings where a user can specify which fields they want to see by default

Scaling

• Independence of resources: All customers run in their own resource pool. While the system is capable of utilising excess resources if required, we can also clamp the resources to ensure a single customer does not impact other users.

Analytics

• Service usage metrics: Yes
• Metrics types: Studies, sites, users and storage
• Reporting types: Reports on request

Resellers

• Supplier type: Not a reseller

Staff security

• Staff security clearance: Other security clearance
• Government security clearance: Up to Baseline Personnel Security Standard (BPSS)

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: ‘IT Health Check’ performed by a Tigerscheme qualified provider or a CREST-approved service provider
• Protecting data at rest:
  • Physical access control, complying with another standard
  • Encryption of all physical media
  • Scale, obfuscating techniques, or data storage sharding
• Data sanitisation process: Yes
• Data sanitisation type: Explicit overwriting of storage before reallocation
• Equipment disposal approach: A third-party destruction service

Data importing and exporting

• Data export approach: User data is exported mainly via reporting - data can be exported in various sections via the grids that are used to display the data.
• Data export formats:
  • CSV
  • Other
• Other data export formats:
  • Microsoft word document format
  • PDF
  • XML
  • XLSX
• Data import formats: CSV

Data-in-transit protection

• Data protection between buyer and supplier networks: TLS (version 1.2 or above)
• Data protection within supplier network: TLS (version 1.2 or above)

Availability and resilience

• Guaranteed availability: Service level agreement (SLA) for availability is included as part of the contract terms and conditions, which also includes details of refunds if guaranteed levels of availability are not met.
• Approach to resilience: All servers are virtualised and clustered. It is designed to be self healing so a working server will always take over from a failed server. We maintain a second facility that keeps a realtime copy of the Data and ensures the whole service is resilient from any hardware failure right through to entire data centre failure. Hourly backups with 90 day retention ensure partial data can be restored from a partial corruption or error.
• Outage reporting: A customer dashboard displays overall SLA levels for the past 12 months.

Identity and authentication

• User authentication needed: Yes
• User authentication: Username or password
• Access restrictions in management interfaces and support channels: We have tightly controlled privileged account access. Support require permission from clients to access their account through the management interface of the site. ; ; Support have no direct access to backend systems and data. Direct management of internal systems controlling the data is tightly controlled by 2 senior employees.
• Access restriction testing frequency: At least every 6 months
• Management access authentication:
  • Identity federation with existing provider (for example Google Apps)
  • 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: Between 6 months and 12 months

Standards and certifications

• ISO/IEC 27001 certification: No
• 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:
  • CyberEssentials Plus Certification
  • DataCentres are ISO27001
  • We are PCI DSS compliant through self assessment.

Security governance

• Named board-level person responsible for service security: Yes
• Security governance certified: Yes
• Security governance standards: Other
• Other security governance standards: CyberEssentials Plus accreditation.
• Information security policies and processes: We have a full ISMS set of policies and processes covering all aspects of our Security and operations. This can be provided on request.

Operational security

• Configuration and change management standard: Supplier-defined controls
• Configuration and change management approach: We maintain a fully secured source control and change management system. All changes are peer reviewed before committing. Deployment of change is only possible from a committed change. We work on lots of small changes rather than significant bulk updates. If we make a substantial change to the solution security, this would trigger a fresh penetration test.
• Vulnerability management type: Supplier-defined controls
• Vulnerability management approach: Aside from regular penetration testing, we operate enterprise grade Malware and intrusion detection. This analyses our logs and services looking for vulnerabilities that match criteria supplied from common threat notification services. These services include IBM, Cylance & Alienvault OTX reports.; ; Patch management systems are in place to ensure critical updates are immediately deployed with Bi-Weekly patch reviews of non critical updates.
• Protective monitoring type: Supplier-defined controls
• Protective monitoring approach: Both our Malware detection and Security Management systems detect threat activities from application behaviour or logged events. If a potential compromise is detected, both are capable of tracing back the source of the compromise which helps identify what that compromise had access up to it's prevention or termination.; ; Potential compromises are investigated as a top priority and we have a full Incident response process to ensure we respond internally and notify users of any breach within the the ICO guidelines.
• Incident management type: Supplier-defined controls
• Incident management approach: We have a full incident management process detailing incident grading and response times. This can be provided on request.

Secure development

• Approach to secure software development best practice: Supplier-defined process

Public sector networks

• Connection to public sector networks: No

Social Value

• Social Value:

  Social Value

  • Fighting climate change
  • Equal opportunity

  Fighting climate change

  As a cloud-based service, our Clinical Trials Management system (ReDA CTMS) offers reduced electricity consumption, higher utilisation rates across the cloud infrasrtucture and reduced reliance on infrastructure than any on-premise application

  Equal opportunity

  We are an equal opportunities employer with a diverse global team. We have active equal opportunities policies for topics such as anti-discrimination, our equitable recruitment and selection process, and flexible working. One of our Core Values, which we use as a selection criteria for recruit, assess performance against, and demonstrate consistently, is 'Respect' which we define as including 'treating others as equals'.

Pricing

• Price: £10,000 to £45,000 a licence a year
• Discount for educational organisations: Yes
• Free trial available: No

Service documents

• Pricing document

  PDF

• Service definition document

  PDF

• Terms and conditions

  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 Russell.Pridmore@infonetica.net. Tell them what format you need. It will help if you say what assistive technology you use.