FAST DATA SCIENCE LTD

Clinical Trial Risk Tool

The Clinical Trial Risk Tool analyses the text of your clinical trial protocol with AI to create an itemised per-subject budget.

Features

• Create clinical trial budget from protocol
• Clinical trial cost benchmarking
• Clinical trial risk assessment

Benefits

• Quickly create itemised clinical trial budgets
• Compare clinical trial costs
• De-risk clinical trials

• Education pricing available
• Free trial 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 thomas@fastdatascience.com. Tell them what format you need. It will help if you say what assistive technology you use.

Framework

G-Cloud 15

Service ID

961759064594172

Contact

Thomas Wood
07906331524
thomas@fastdatascience.com

About your service

• Service categories:

  Applications

  Production and operations

  Service industry and public sector operations

  • Healthcare
• Multi cloud support: Yes

Service scope

• Software add-on or extension: No
• Cloud deployment model:
  • Public cloud
  • Private cloud
  • Community cloud
  • Hybrid cloud
• Service constraints: None
• System requirements:
  • Internet access
  • Optional - cloud computing e.g. Azure, AWS

User support

• Email or online ticketing support: Yes
• Support response times: Same day, next working day if at weekends
• User can manage status and priority of support tickets: No
• Phone support: Yes
• Phone support availability: 9 to 5 (UK time), 7 days a week
• Web chat support: No
• Onsite support: Yes, at extra cost
• Support levels: Clients can use the Clinical Trial Risk Tool on our cloud or hosted on their own cloud account. Our hosted packages start at $80/month. If self-hosted, the cost depends on the cloud platform, and full support is provided to keep the software up to date and ensure close to 100% uptime.
• Support available to third parties: Yes

Onboarding and offboarding

• Getting started: User documentation including video tutorials are available, in addition in-person or remote training can be provided.
• Service documentation: Yes
• Documentation formats:
  • HTML
  • PDF
• End-of-contract data extraction: By request or data dump via the API
• End-of-contract process: At end of contract, all data can be dumped and the access to the service will end.
• Documentation accessibility standard: WCAG 2.2 A

Using the service

• Web browser interface: Yes
• Supported browsers:
  • Microsoft Edge
  • Firefox
  • Chrome
  • Safari
  • Opera
• Application to install: No
• Designed for use on mobile devices: No
• Service interface: No
• User support accessibility: None or don’t know
• API: Yes
• What users can and can't do using the API: Users can authenticate and upload document and retrieve budgets and cost estimates via the API.
• API documentation: Yes
• API documentation formats: Open API (also known as Swagger)
• API sandbox or test environment: Yes
• Customisation available: No

Scaling

• Independence of resources: Users can be granted a dedicated hosted API. Performance of the API is monitored and resources can be added if there is a load on the server.

Analytics

• Service usage metrics: No

Resellers

• Supplier type: Not a reseller

Staff security

• Staff security clearance: Other security clearance
• 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: Yes
• Datacentre security standards: Managed by a third party
• Penetration testing frequency: Never
• Protecting data at rest:
  • Physical access control, complying with another standard
  • Encryption of all physical media
• Data sanitisation process: No
• Equipment disposal approach: In-house destruction process

Data importing and exporting

• Data export approach: Users can go into the history view and export all uploaded files as an Excel.
• Data export formats:
  • CSV
  • Other
• Other data export formats: Excel
• Data import formats:
  • CSV
  • Other
• Other data import formats: Excel

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: Three nines (via Microsoft Azure VMs)
• Approach to resilience: We use Microsoft Azure Database for PostgreSQL which is designed for high resilience and business continuity using a combination of high availability (HA) features, backup and restore capabilities, and disaster recovery options.
• Outage reporting: Email alerts and API

Identity and authentication

• User authentication needed: Yes
• User authentication:
  • Multi-Factor Authentication (MFA)
  • Public key authentication (including by TLS client certificate)
  • Username or password
• Access restrictions in management interfaces and support channels: Password authentication
• Access restriction testing frequency: At least every 6 months
• Management access authentication:
  • Multi-Factor Authentication (MFA)
  • Public key authentication (including by TLS client certificate)

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: Between 6 months and 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: Between 6 months and 12 months
• How long system logs are stored for: Between 6 months and 12 months

Security governance

• Named board-level person responsible for service security: Yes
• Security governance certified: No
• Security governance approach: Our governance framework is focused on GDPR and we meet all GDPR requirements. All data uploaded to our services can be deleted permanently by the users. We practise pro-active risk management, and clear ownership is assigned for specific datasets and security processes. Our privacy policy is available: https://fastdatascience.com/privacy-policy/
• Information security policies and processes: The Data Protection Officer is the Director, Thomas Wood. We publish clear privacy policies detailing what data is collected, why (lawful basis), how long it is kept (retention), and how it is disposed of. This acts as a documented standard that employees must follow.; We report directly to regulators (ICO) if a breach occurs and bear the legal burden for policy compliance.
• Software Security Code of Practice: Yes

Operational security

• Configuration and change management standard: Supplier-defined controls
• Configuration and change management approach: We use Git as a Version Control System: All source code, infrastructure code (IaC), and configuration files (settings, secrets references, environment variables) are stored and tracked in the system.; ; Infrastructure as Code (IaC): Microsoft Azure Resource Manager is used to define cloud resources (servers, databases, network rules) using code.
• Vulnerability management type: Undisclosed
• Vulnerability management approach: We use application security testing, automated dependency scanning, and automated monitoring of cloud configurations.
• Protective monitoring type: Undisclosed
• Protective monitoring approach: We identify compromises by monitoring Indicators of Compromise (IOCs) like anomalous user logins, unusual data downloads, or security misconfigurations using SIEM (Security Information and Event Management) tools.; When an IOC is found, we respond by following a structured Incident Response Plan. Response involves immediate containment (isolating the affected system), eradication, and recovery. We aim for containment within hours to minimise client data loss or exposure, followed by mandatory regulatory reporting (UK GDPR).
• Incident management type: Undisclosed
• Incident management approach: Internal pre-defined processes are kept for data breaches.; ; User Reporting: Users and clients report issues via established support channels or a dedicated email address for data protection contacts (as per GDPR).; ; Incident Reports (Regulatory): Fast Data Science is obligated to report personal data breaches to the ICO within 72 hours if a risk to individuals is likely.; ; Incident Reports (Internal/Client): A formal Post-Incident Review (blameless post-mortem) is completed internally and shared as an executive summary with affected clients.
• Post-quantum cryptography secure: No

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

• Discount for educational organisations: Yes
• Free trial available: Yes
• Description of free trial: Included: trial risk assessment, budgeting; Excluded: trial budget export
• Link to free trial: https://clinicaltrialrisk.org/

Discount percentage by annual call-off contract value (excluding VAT)

• Less than £250,000: 10%
• Between £250,000 and £500,000: 10%
• Between £500,001 and £1,000,000: 10%
• Between £1,000,001 and £2,500,000: 10%
• Between £2,500,001 and £5,000,000: 10%
• Over £5,000,001: 10%

Non-mandatory Standards and certifications

• ISO/IEC 27001 certification: No
• ISO 28000:2022 certification: No
• ISO 9001 certification: No
• Quality management systems (QMS): Yes
• CSA STAR certification: No
• PCI certification: No
• Cyber essentials: No
• Cyber Essentials Alternative: None of the criteria
• Cyber essentials plus: No
• Cyber Essentials Alternative: None of the criteria
• Other security certifications: No

Social value

• Section B - Commitment for Future: Delivery:

  • Mission: Kick start economic growth. To secure the highest sustained growth in the G7 - with good jobs and productivity growth in every part of the country making everyone, not just a few, better off.

    Policy Outcome 1: Fair work: That offers fair wages and good working conditions. Help people get a job, stay in work, and progress in their careers, with good employment opportunities across the country. Notes: Where there is a large proportion of labour costs in the contract, commercial teams should consider MAC in Outcome 1 as a priority

    • New or retained jobs on the contract workforce in the relevant area that meet the criteria set out in MAC 1b, 1c and 1d
    • Providing opportunities for, and measuring and monitoring of, staff workforce conditions over time, including employee engagement, involvement in decision-making and satisfaction and adapting to any changes in the results, with clear processes for acting on issues identified
    • Plans to engage the contract workforce in deciding the most important workplace issues to address
    • Ensuring new workers are informed of their right to join a trade union
    • Monitoring of employee engagement rates (by protected characteristic) and, where necessary, the development of actions to ensure all voices are heard across the diversity of the workforce
    • Employment contracts that reflect actual hours worked; steps taken to ensure employees understand their contracts and have the ability to review and adjust them if actual hours regularly exceed contracted hours
    • Activities that support an environment where staff are educated about, and feel empowered to, address their physical wellbeing
    • Activities that support an environment where staff are educated about and feel empowered to report and address bullying and harassment
    • Activities to cascade good practice on fair working conditions throughout the supply chain
    • Offer a pay and leave entitlement to all eligible staff who become kinship carers, ideally equivalent to statutory adoption pay and leave
    • Payment of more than the National Minimum Wage or National Living Wage (as appropriate) to the contract workforce
    • Monitoring and reporting of gender and ethnicity pay gaps and plans to address them where necessary
    • Entitlement to sick pay for the contract workforce, with provision in place for any staff who do not meet the earnings threshold for statutory sick pay, payment of sick pay from day one of absence and payment of staff on the contract workforce who are off sick a replacement income of 100% of their usual earnings for as long as possible
    • Understanding of in-work progression issues affecting the market, industry or sector relevant to the contract, and in the supplier’s own organisation and those of its key sub-contractors
    • Measures to support in-work progression to help people in the contract workforce, to move into higher paid work by developing new skills relevant to the contract
    • Support for the contract workforce by providing career advice, and providing opportunities for staff working on the contract with in-work progression career development into known skills shortages or high growth areas
    • Support for educational attainment relevant to the contract, including training schemes that address skills gaps and result in recognised qualifications
    • Understanding of the modern slavery risks and issues affecting the market, industry, sector or country (of origin or of source) relevant to the contract, and the workforce in the supplier’s own organisation and those of its key subcontractors
    • Measures to identify, mitigate and manage modern slavery risks relating to the contract and how these will be implemented
    • Outline policies and practices to be applied to or put in place for the contract to mitigate and manage modern slavery risks, including: Pre-employment checks, recruitment practices. Workplace conditions, safeguarding plans and processes in place and regular monitoring with relevant groups considered, which may include sampling
    • How these flow down the supply chain and are monitored Illustrative examples include reporting, site visits, audits, etc.
    • How to ensure business decisions re: price/cost, short lead times, payment timescales do not create modern slavery risks in the supply chain
    • How the supplier will work with NGOs, trade unions or other businesses to address modern slavery risk
    • Means of influencing staff, suppliers, customers, communities and/or any other appropriate stakeholders with respect to modern slavery risks relating to the contract

  • Mission: Kick start economic growth. To secure the highest sustained growth in the G7 - with good jobs and productivity growth in every part of the country making everyone, not just a few, better off.

    Policy Outcome 2: Skills for growth: Supporting growth sectors and addressing skills gaps.

    • Understanding of employment and relevant skills issues, and of the education and training issues relating to the contract. Illustrative examples: demographics, skills shortages, new opportunities in high growth sectors, geographic/local community and skills/employment challenges
    • Support for educational attainment relevant to the contract, including training schemes that address skills gaps and result in recognised qualifications
    • Activities to support relevant sector related skills growth and sustainability in the contract workforce. Illustrative examples: careers talks, curriculum support, literacy support, safety talks and volunteering

  • Mission: Kick start economic growth. To secure the highest sustained growth in the G7 - with good jobs and productivity growth in every part of the country making everyone, not just a few, better off.

    Policy Outcome 3: Resilient, innovative and flexible supply chains: Support economic growth through enabling resilient businesses, opportunities for small businesses and voluntary, community and social enterprises

    • Understanding of the types of businesses in the market and the level of participation by new businesses, entrepreneurs, start-ups, SMEs, VCSEs and mutuals
    • Activities to identify opportunities to open up sub-contracts under the prime contract to a diverse range of businesses, including new businesses, entrepreneurs, start-ups, SMEs, VCSEs and mutuals
    • Plans for engaging a diverse range of businesses in engagement activities prior to appointing subcontractors (including activities prior to award of the main contract and during the contract term)
    • Activities that demonstrate a collaborative way to work with a diverse range of businesses as part of the supply chain
    • Advertising of supply chain opportunities openly and to ensure they are accessible to a diverse range of businesses, including advertising all subcontracting opportunities on Contracts Finder
    • Ensuring accessibility to contracting and subcontracting opportunities for disabled business owners and employees
    • Structuring of the supply chain selection process to ensure fairness (e.g. anti-corruption) and encourages participation by a diverse range of businesses, including with regard to new businesses, entrepreneurs, start-ups, SMEs, VCSEs and mutual
    • Understanding of local demographics, needs and opportunities for the co-design of the goods, services and works to be delivered under the contract
    • Methods for engaging with different parts of the community (including the education system and charities representing the community) and how communities come together to inform decisions, strategy and projects to leave a positive legacy for future generations
    • Measures to involve local stakeholders and/or users in design (e.g. in the design of services, systems, products or buildings)
    • Plans for positive actions with community groups.
    • Measures for making facilities used in the delivery of the contract available for community groups, education or training
    • Measures to engage users and communities and build relationships to increase community integration build trust and influence how the contract is delivered
    • Plans to respond flexibly and adapt approaches to community engagement and initiatives

  • Mission: Break down barriers to opportunity: By reforming our childcare and education systems, to make sure there is no class ceiling on the ambitions of young people in Britain

    Policy Outcome 6: Employment and training: For those who face barriers to employment

    • Understanding of employment and skills issues, and of the skills and employment shortages of high growth sectors relating to the contract
    • Creation of employment opportunities particularly for those who face barriers to employment, such as prison leavers, care leavers and/or who are located in deprived areas, and for people in industries with known skills shortages or in high growth sectors
    • Delivery of training schemes and programmes to address any identified skills gaps and under-representation in the workforce for the contract (e.g. prison leavers, care leavers, kinship carers, disabled people)
    • Understanding of the issues affecting the representation of disabled people in the workforce in the market, industry or sector relevant to the contract, and in the supplier’s own organisation and those of its key sub-contractors
    • Collection of the views and expertise of disabled people and their representative organisations on successfully supporting disabled employees or applicants
    • Inclusive and accessible recruitment practices, and retention-focused activities, including those provided in the Guide for line managers on recruiting, managing and developing people with a disability or health condition
    • Introducing transparency to pay and reward processes
    • Offering a range of quality opportunities with routes of progression if appropriate, e.g. T Level industry placements, students supported into higher level apprenticeships.
    • Working conditions which promote an inclusive working environment and promote retention and progression
    • Understanding of the issues affecting inequality in employment, skills and pay in the market, industry or sector relevant to the contract, and in the supplier’s own organisation and those of its key sub-contractors. Measures to tackle inequality in employment, skills and pay in the contract workforce
    • Inclusive and accessible development practices, including guidance for line managers on recruiting, managing and developing people with a disability or health condition

  • Mission: Break down barriers to opportunity: By reforming our childcare and education systems, to make sure there is no class ceiling on the ambitions of young people in Britain

    Policy Outcome 7: Creating a pipeline of opportunities: For the contract workforce, reducing barriers to entry for under-represented groups.

    • Understanding of the issues affecting the development of new skills by target cohort
    • Understanding of the underlying factors affecting improvements to reduce barriers to entry and training schemes for the target cohort(s) related to the contract workforce
    • Other measures to offer development opportunities for the target cohort(s) in the contract workforce
    • Understanding of issues relating to entering the contract workforce
    • Creation of outreach activities to create a pipeline of employees for the future contract delivery
    • Content of the outreach activity is designed to suit the target cohort

  • Mission: Build an NHS fit for the future: That is there when people need it; with fewer lives lost to the biggest killers; in a fairer Britain, where everyone lives well for longer.

    Policy Outcome 8: Increasing productivity through physical and mental wellbeing: In the supply chain and communities in the relevant area.

    • Understanding of issues relating to health and wellbeing, including physical and mental health, in the contract workforce
    • Understanding barriers to access to health and social care services or employment opportunities e.g. digital inclusion
    • Inclusive and accessible recruitment practices, development practices and retention policies that support-focused activities including those provided in the Guide for line managers on recruiting, managing and developing which support people with a disability or health condition

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 thomas@fastdatascience.com. Tell them what format you need. It will help if you say what assistive technology you use.