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RESEARCH GRID LTD

TrialEngine

TrialEngine is a smart clinical trial automation system (CTAS) that handles the administration, data, and reporting workflows during the trial and post-trial.

It leverages custom AI algorithms and process automation to complete tasks such as protocol development, study documents and data extraction in a matter of minutes.

Features

  • CTAS: Clinical trial automation system for centralised, hybrid research
  • eTMF: Smart eTMF and auto-document creation and quality control
  • EDC: Secure data capture, extraction, anonymisation, evaluation, and management
  • Finance: Trial costing and negotiations, including grant/SoECAT/AcoRD costing formats
  • Patient portal: Patient management (auto-anonymisation, individual/group/mass communication)
  • RG.plug: Bespoke integrations to centralise your workflow
  • Clinical.net: Collaborative networks to increase engagement, relationships, and manage stakeholders
  • RG.data: Advanced AI-powered data analytics
  • Training: Custom training management and automatic trainee and certification tracking
  • Anonymisation: Easy multi-level patient and communication anonymisation management

Benefits

  • Dramatically streamlines admin with a 90% increase in efficiency
  • Reduces administrative burden with a 30% decrease in cost
  • Patient-centric and accessible with DEI support for increased inclusivity
  • Suitable for all trial types, including hybrid/decentralised trials
  • Unified and intuitive platform
  • Fully customisable with interoperability and integration support
  • Robust support with onboarding, help, and account management
  • Centralised stakeholder management with streamlined communication
  • Intelligent reporting and trends

Pricing

£2,000 to £600,000 a unit

  • Education pricing available

Service documents

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 sales@rgrid.tech. Tell them what format you need. It will help if you say what assistive technology you use.

Framework

G-Cloud 14

Service ID

3 4 0 7 3 5 9 5 7 0 3 6 5 0 6

Contact

RESEARCH GRID LTD Business Team
Telephone: +44 20 3576 2539
Email: sales@rgrid.tech

Service scope

Software add-on or extension
Yes, but can also be used as a standalone service
What software services is the service an extension to
Some of our services can be integrated into our existing systems via our APIs.
Cloud deployment model
Public cloud
Service constraints
Our service is accessible through all major browsers including Internet Explorer, Google Chrome (Chrome, ChromeOS, ChromeBook), Apple Safari, Mozilla Firefox, Microsoft Edge, Opera, Brave, JAWS, and NVDA (screen readers), both for Windows and Mac users.
System requirements
  • Online-access via major browsers (Chrome/Firefox/Edge/Safari/Opera) or ADSL/3G/4G/5G on any device.
  • Offline-access to documents/files requires downloading them to your computer/laptop/mobile

User support

Email or online ticketing support
Email or online ticketing
Support response times
We aim to respond to tech support queries within 1 business day. There is no difference in response time at weekends. Once clients submit their query, they will be given a ticket/reference number which they can use to check the status of their query.
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
9 to 5 (UK time), Monday to Friday
Web chat support
No
Onsite support
Yes, at extra cost
Support levels
Support is provided in a two-tier system.

Included Support (included in the package price):
(1) Automatic onboarding and instructional prompts;
(2) Accessibility support;
(3) Comprehensive help with videos, screen images, and step-by-step guidance and automated search support to help the user automatically find the best answer to a question;
(4) Modular help support on each page;
(5) General ticketed support via email or virtual calling/meetings;
(6) General technical support tickets.

Additional Services Options (starting at £2.000 per service):
(A) Technical Setup Support;
(B) Data migration and integrations support;
(C) Staff onboarding and training;
(D) Dedicated technical account manager or cloud support engineer.
Support available to third parties
Yes

Onboarding and offboarding

Getting started
We have a comprehensive onboarding infrastructure to help new users familiarise themselves with our service detailed below. Alongside this onboarding, our Account manager will guide new users to help them familiarise themselves with our service and how to navigate it. We also provide user onsite onboarding training - per request at an additional charge. Comprehensive onboarding includes: (1) Onboarding training is an extensive meeting, workshop, or training session(s) that support clients with our services based on their needs. (2) Guided online training are automated step-by-step navigation guides, how to use every TrialEngine feature. (3) User documentation includes screenshots and videos of our service explaining how to use each specific section and tool. We include a Help menu in the main menu and a help button on every page to ensure help is easily found, questions are searchable, and answers are detailed effectively. (4) A dedicated account manager
Service documentation
Yes
Documentation formats
  • HTML
  • PDF
  • Other
Other documentation formats
  • .MOV
  • .JPG
End-of-contract data extraction
In the event that a client ends their contract, TrialEngine will retain all project data for a period of six months from the last date of the subscription or contract, whichever applies. The client then has these six months to make a final download to extract their data individually or as a whole in a ZIP file from our system. TrialEngine will provide access to download all project data and associated metadata for all projects stored on TrialEngine. It is the responsibility of the Sponsor and Research team to ensure that documents are retained for the duration of the retention period according to the relevant regulations dependent on study type and location. TrialEngine bears no responsibility for data being retained beyond 6 months after a client leaves.
End-of-contract process
When a payment is coming up, we send our clients an email, reminding them. They can cancel subscription or contract on their Account Settings page and we will give them a deadline for the end of their service. In the event that a client leaves TrialEngine, we will retain all project data for a period of six months from the last date of the subscription or contract, whichever is relevant. We send reminders sent to the client so they are aware of the deadline to download their data from our system.

While we are holding it for six months, clients have the option to extract the data from our system. Their data is hard deleted after 6 months. TrialEnginewill provide access to download all project data and associated metadata for all projects stored on TrialEngine.

It is the responsibility of the Sponsor and Research team to ensure that documents are retained for the duration of the retention period according to the relevant regulations dependent on study type and location. TrialEngine bears no responsibility for data being retained beyond six months after a client leaves TrialEngine.

Using the service

Web browser interface
Yes
Supported browsers
  • Internet Explorer 11
  • Microsoft Edge
  • Firefox
  • Chrome
  • Safari
  • Opera
Application to install
No
Designed for use on mobile devices
Yes
Differences between the mobile and desktop service
The mobile and desktop service both offer the same service and include the same features. The interface on the mobile version is altered to fit the smaller screen so no information is omitted while being easy to navigate for our clients.
Service interface
Yes
User support accessibility
WCAG 2.1 AA or EN 301 549
Description of service interface
We have a service interface that is customisable for each user depending on what they need. It can be used to display all information relevant to each user with menus to help them easily navigate our system.

Depending on if the user is accessing our service from a phone or laptop/PC, the interface will look different as it adapts to the screen so it is always suitably scaled for how users are viewing it. We have a range of accessibility standards that the users can access.
Accessibility standards
WCAG 2.1 AA or EN 301 549
Accessibility testing
(1) Epilepsy Safe Profile: this profile enables people with epilepsy to safely use the website by eliminating the risk of seizures resulting from flashing or blinking animations and risky colour combinations;

(2) ADHD Friendly Profile: this profile significantly reduces distractions and noise to help people with ADHD, and Neurodevelopmental disorders browse, read, and focus on the essential elements more easily;

(3) Keyboard Navigation Profile (Motor-Impaired): this profile enables motor-impaired persons to operate the website using the keyboard Tab, Shift+Tab, and the Enter keys. Users can also use shortcuts such as “M” (menus), “H” (headings), “F” (forms), “B” (buttons), and “G” (graphics) to jump to specific elements.

(4) We also support screen-readers and keyboard navigation optimisation.
API
Yes
What users can and can't do using the API
Public APIs can be used to integrate our Community Network Search Service, Quick Extract Data Processing Service, and Text Processing Service.

Community Network Service:
Find and connect with new communities and build more diverse participation and relationship building. The API expects the user to search by a condition, location, symptoms, demographics, size, group type and provides the applicable information

Quick Extract Data Processing:
Digitise paper questionnaires by using the API to instantly extract data from surveys to reduce the time burdens of data entry. Digitise questions and answers, and control accuracy with our built-in error detection locators. The accuracy detector will pick up any errors, flag them, and display their location in the survey, assessment, or questionnaire. The API expects users to provide pre-filled surveys and extracts structured survey information.

Text-Processing Service:
Auto-digitise your documents for easy management, version control and compliance. Automatically extract text and the structure of your documents to streamline compliant updates and version control. The API requires users to provide a protocol document and returns a structured text.
API documentation
Yes
API documentation formats
  • HTML
  • PDF
API sandbox or test environment
Yes
Customisation available
Yes
Description of customisation
Clients can customise TrialEngine’s system or tools. The system can be customised by branding, workflows, and integrations. TrialEngine tools can be customised with their client templates, data, or work.
Customisation of system:
(1)Clients can upload their own branding
(2)Clients can purchase the specific tools/features/modules required and use these in TrialEngine or their own systems.
(3)Clients can buy additional tools to scale their work without disruptions.
(4)The system auto-scales for clients needs irrespective of users numbers on their account

Customisation of features:
(1)Clients can upload their own document templates or pre-existing data for the information to be extracted, displayed, and customised in the system
(2)Reports can be customised to the format that best suits the client. This means, the visible display of data can be switched between chart types (e.g. pie charts, bar charts, etc.)
(3)Clients can upload their own training and monitor trainees and certifications
(4)Clients can upload and manage their own contacts and access points for users
(5)Clients can customise the reports they receive, for example, they can change a chart types, text, and how each is arranged on surveys, dashboards, and reports.

Scaling

Independence of resources
Our platform is auto-scalable. There are no restrictions around number of users that can simultaneously use the system. Data migration and document upload can be easily done directly by users to avoid creation of onboarding bottlenecks. We have implemented the functionality of running our software on multi-thread mode (multiple instances to cater simultaneous requests at the exact same millisecond). Our system can handle 4 resource heavy functionalities triggered at the exact same millisecond. This limit will increase with the increase in number of users on our system as this is software scaling implementation from code-end and EC2 Instance end.

Analytics

Service usage metrics
Yes
Metrics types
Current numbers and limits in regard to:
Users;
Collaborators;
Contacts (Participants/Patients);
Communication Groups;
Projects;
Community Groups/Relationships;
Trial statistics;
Bespoke statistics and reports (user-specific);
Patient survey data;
Open queries;
File sorting;
Comments tracking;
Meta-data;
Data usage;
Insights data;
Research data;
Access management data;

All metrics are visible in real-time for users in a dashboard or customisable set-up. Data usage is available via Subscription Settings. Access management is available in Account Settings. Other data is available in reports.
Reporting types
  • API access
  • Real-time dashboards
  • Regular reports
  • Reports on request

Resellers

Supplier type
Not a reseller

Staff security

Staff security clearance
Conforms to BS7858:2019
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
Complies with a recognised standard (for example CSA CCM version 3.0)
Penetration testing frequency
Less than 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 CSA CCM v3.0
  • 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
Deleted data can’t be directly accessed
Equipment disposal approach
Complying with a recognised standard, for example CSA CCM v.30, CAS (Sanitisation) or ISO/IEC 27001

Data importing and exporting

Data export approach
Users can export selective data for their account as a ZIP file or individual files any time they want. Users can also request an export of all data associated with their account at once from our support team.
Data export formats
  • CSV
  • Other
Other data export formats
PDF
Data import formats
  • CSV
  • Other
Other data import formats
  • PDF
  • JPEG
  • DOCX
  • PNG

Data-in-transit protection

Data protection between buyer and supplier networks
  • IPsec or TLS VPN gateway
  • Legacy SSL and TLS (under version 1.2)
Data protection within supplier network
Legacy SSL and TLS (under version 1.2)

Availability and resilience

Guaranteed availability
System availability: 99.5% monthly uptime excluding scheduled maintenance or unavailability due to a force majeure event. The service credit for each month for this is 0.275% of the base fee.

Customer response times: We respond to every customer service request within 1 working day of receipt. The service credit for each month for this is 0.275% of the base fee.
Approach to resilience
Our multiple servers are connected is such a way that if one fails there is a copy stored on another server. They are robust and fully scalable for excessive amounts of data
In addition, small account modifications, are stored on our databases and backed up for 35 days to protect against accidental errors or deletions. Copies of data from a user’s account is stored for 6 months if an account is deleted.
We run cybersecurity penetration testing of our systems regularly. We stress test our systems regularly and generate reports for maintenance and operations. We run comprehensive quality assurance testing on all new features / code prior to making these available to customers and users.
Further details regarding the implementation, can be made available on request.
AWS Regions provide multiple physically separated and isolated Availability Zones, which are connected with low-latency, high-throughput, and highly redundant networking. Availability Zones are more highly available, fault tolerant, and scalable than traditional single or multiple data centre infrastructures. Since we are using AWS DynamoDB, we have implemented Point-in-time recovery (PITR), which provides continuous backups of your DynamoDB data for 35 days to help you protect against accidental write or deletes.
Outage reporting
We have a dashboard that is customisable for each client. If we experience any outages we update this dashboard for all customers informing them of the outage and if possible giving them a approximate timescale for when the problem will be resolved. We understand that not everyone will be using the service at the time of the outage so we will send emails to each client.

Identity and authentication

User authentication needed
Yes
User authentication
Username or password
Access restrictions in management interfaces and support channels
(Internal):
There are two levels of secure and managed access: the backend (tech staff, management interface) and the front-end (business staff, support channels): On the back-end, each tech team staff has their own AWS Identity and Access Management (IAM) user, with limited access that is trackable. On the front-end some staff have restricted IAM for subscriptions, and authentication and validation process of new clients.

(External/Clients):
No user has access to the management interfaces of the product as the software uses the restricted IAM user credentials.

Users can manage access levels of their own staff, collaborators, or participants within their accounts.
Access restriction testing frequency
At least every 6 months
Management access authentication
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

Standards and certifications

ISO/IEC 27001 certification
Yes
Who accredited the ISO/IEC 27001
Approachable Certification, UCAS Management Systems
ISO/IEC 27001 accreditation date
21 February 2023
What the ISO/IEC 27001 doesn’t cover
All company activities are covered by the ISO/IEC 27001.
ISO 28000:2007 certification
No
CSA STAR certification
Yes
CSA STAR accreditation date
19/05/2022
CSA STAR certification level
Level 1: CSA STAR Self-Assessment
What the CSA STAR doesn’t cover
Not applicable
PCI certification
No
Cyber essentials
Yes
Cyber essentials plus
No
Other security certifications
Yes
Any other security certifications
  • OWASP security tested
  • Registered with ICO

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
We are Cyber Essentials Certified, OWASP security tested, externally cybersecurity pentested, and CSA Star Level 1 compliant. We use the NHS Data Security and protection toolkit and are compliant in UK DPA, GDPR, HIPAA, MHRA and FDA.
Information security policies and processes
We adhere to GDPR standards and are compliant with the UK Data Protection Act 2018. We are HIPPA and MHRA compliant. The Company has roles and responsibilities to deliver, maintain and improve its integrated management system to conform to the requirements of the ISO 27001 standards and are CSA Star level 1. We monitor security audit logs to detect activity outside of typical or expected patterns. We then follow a defined process to review and take appropriate and timely actions on detected anomalies. Our reporting structure is outlined within the Quality, Environment & Occupational Health & Safety Management System Manual (Integrated Management System (IMS) Manual). TrialEngine security policies and protocols are described within the Information Security Management System SOP.

Operational security

Configuration and change management standard
Conforms to a recognised standard, for example CSA CCM v3.0 or SSAE-16 / ISAE 3402
Configuration and change management approach
The clinical and security components of our services are tracked through their software development lifecycle, rigorously documented, signed-off, and externally audited for computer systems validation and cybersecurity. System changes are assessed for potential security impact, audited then penetration tested externally.
Vulnerability management type
Conforms to a recognised standard, for example CSA CCM v3.0 or SSAE-16 / ISAE 3402
Vulnerability management approach
We assess potential threats through a risk registry and mitigation plan, adherence to OWASP standards, and carrying out regular external audits and security penetration testing. We respond on the same-day, ad-hoc and as needed.

We get information about potential threats from internal controls and risk registers monitoring, market research and benchmarking, market standards, and Regular External Security Penetration Testing.
Protective monitoring type
Conforms to a recognised standard, for example CSA CCM v3.0 or SSAE-16 / ISAE 3402
Protective monitoring approach
TrialEngine plans, implements, evaluates, and controls the processes needed to meet the requirements and provisions of the products and services which are provided. The company continuously evaluates processes, procedures and technical measures for the reporting of anomalies and failures of the monitoring system and provide immediate notification to the accountable party. These processes are externally audited. Potential compromises are documented and logged as they arise and/or are reported/communicated. They are then forwarded to relevant team members, evaluated and resolved as soon as possible. Same-day correspondence and any technical patches or improvements are carried out as soon as possible.
Incident management type
Conforms to a recognised standard, for example, CSA CCM v3.0 or ISO/IEC 27035:2011 or SSAE-16 / ISAE 3402
Incident management approach
At TrialEngine all nonconformities must be recorded, managed and resolved according to the appropriate SOP. Nonconformities are also reviewed to help eliminate future re-occurrences of that nonconformity.

In the event of a nonconformity identified where there is not an appropriate SOP available, a mitigation plan and SOP will be put into place immediately.

Customers can report incidents directly via email, within the technology system via the Help tab, Technical Support tab, and Feedback button.

The customer/user is notified that the support ticket has been resolved.

Secure development

Approach to secure software development best practice
Independent review of processes (for example CESG CPA Build Standard, ISO/IEC 27034, ISO/IEC 27001 or CSA CCM v3.0)

Public sector networks

Connection to public sector networks
No

Social Value

Social Value

Social Value

  • Fighting climate change
  • Covid-19 recovery
  • Tackling economic inequality
  • Equal opportunity
  • Wellbeing

Fighting climate change

Fighting climate change is a top priority for us and we ensure we always adhere to the Environment Act 2021 and to ISO 14001. We provide staff with training which encourages behavioural environmentalism within the workplace. Further information regarding this can be found within our Corporate Social Responsibility Policy. The efforts we take as a company include reducing single use plastics around the workplace and putting in place environmental management strategies that are then disseminated too staff through the employee handbooks.

In order to monitor our environmental efforts, we set and review KPIs regularly, for example, We are committed to reducing our CO2 emissions and aim to decrease to at least 15.57 tCO2e by 2027 in line with our Carbon Resuction plan.. We will also employ the DMAIC (Define, Measure, Analyse, Improve, Control) method to monitor and improve our sustainable processes when needed throughout this project.

We significantly reduce our carbon footprint by:
We work virtually which reduced the use of personal cars too travel into the office
99% of our customer meetings are done virtually to reduce travel for both our employees and our customers
We use 99% electronic copies of all items and we support customers to streamline all of their administration and engagement/ communication activities with our software which reduces the paper used by both us and our customers.
80% reduction in equipment costs, utilise agile software approaches rather than hardware.

Covid-19 recovery

We believe COVID-19 recovery and resilience to possible future events required a reimagining of the workplace talent and how we conduct our business to help us leverage the skills our staff possess while addressing demand for critical skills in digital roles.

We aim to reduce the barriers to entry that candidates face when attempting to enter the industry. We plan to do this using psychometric testing. Using psychometric testing allows us to identify people who may have been otherwise overlooked.

We are committed to maintaining a clean and safe working environment to help minimise transmission of COVID-19. We do this by:
Implementing and adhering to social distancing measures;
Encouraging employees to stay at home and get a COVID-19 test if they are feeling well of displaying symptoms;
Introducing working from home for employees that are required to self isolate but are still able to work;
If an employee has a client facing role, we give them the autonomy to decide whether they would prefer to conduct their meetings in person or virtually via Zoom or Microsoft teams.

To maintain our performance and safety, we carry out regular reviews to ensure our businesses is running effectively. These reviews are carried out against changing COVID-19 restrictions and shifting client demand and behaviours. These reviews cover:
Lessons learnt during the COVID-19 pandemic;
Shifting market conditions;
Shifting operational behaviours.

Tackling economic inequality

To help tackle economic inequality we provide jobs for a range of different skill sets. We provide staff with the relevant training to be successful in this role if they did not have it previously. This helps people get into employment as we are removing barriers to entry for them by training internally. We look at hiring people not previously in work or education to help reduce the unemployment rate.

We ensure our employees' contracts all fulfill the criteria to be classed as “good work” which means we provide our employees with:
Fair pay;
Progression;
Autonomy;
This helps us create a skilled workforce who can progress in their chosen career. We are committed to hiring locally and from the local area.
We are committed to offering apprenticeships and aim to continue this and offer more through the coming years. Alongside apprenticeships, we offer internships for people looking to work for our company. These can vary in length and can result in employment at the end. If we do not employ the intern full-time following the conclusion of their internship, they will still have learned valuable skills from us that they can use to further their career and we will provide references to future employers. We pay above the National Minimum Wage to demonstrate to our staff that we value their contribution to our business.

Equal opportunity

We are an equal-opportunity employer. Our Equality and Diversity policy ensures that our hiring process is fair and open to everyone. This ensures we have a diverse workforce where no one is favored or discriminated against because of their culture, religion, ethnicity or background. We have a zero-tolerance for discrimination. We have clear procedures in place to report discrimination if it is witnessed.

Equal opportunities are measured during out recruitment stage as we have the information regarding the percentage of men/women applying for our roles as well as how many people from different backgrounds. This allows us to set hiring objectives to ensure we remain diverse and that our opportunities are available for everyone who is qualified for the role. Our interview process is based on a scoring system which allows us to be objective when making our hiring decisions. Members of staff who interview are provided anonymised information to prevent from any initial prejudice/bias. This has led to us having a diverse and TrialEngine workforce. Staff are also provided with equality training. We provide unsuccessful candidates with reasons for rejection.

60% of our workforce are women and there is no gender pay gap as we ensure is paid for the role they carry out regardless of background.

We offer flexible working to staff if they are finding it difficult to get to the office for any reason, e.g., due to a disability. We would allow them to work from home when needed and would meet with them to see what we could do to ensure they are comfortable at work.

Wellbeing

The wellbeing of our staff is of utmost importance to us. We ensure all staff know where they can go if they are struggling at work or having difficulties at home. We have a wellbeing lead who staff can approach to talk to about any issues they may be having. We ensure we always adhere to the 6 standards for Mental Health at work commitment. These are: Prioritising Mental health in the workplace by developing a programme of activity; Ensuring organisational culture promote wellbeing; Having an open culture around mental health; Increasing organisational capability and confidence; Providing mental health tools and support; Increase transparency through internal and external reporting. Ensuring we are always following these standards is important to us so to do this we: Ensure our staff always adhere to the positive culture of the workplace and know where to go when they need to talk; Regular meetings with staff to discuss their wellbeing any anything the company could do to support them; Recent employees have more frequent check ins to catch up with them and check in on their wellbeing. We have mental wellness training, application, and services available for staff: Providing free, confidential professional mental health therapy session as a one-off or in a course of 6-sessions for staff who have noticed a decline in their wellbeing; Applications where staff can ask a therapist any question confidentially and report how they are feeling. This helps them track how their wellbeing is changing which helps them see when it may be beneficial for them to use the counselling services available to them; Wellbeing time off – We offer free company days off each quarter that don’t count toward annual leave; Wellness training for managing work-life balance to avoid burnout; Flexible work weeks periodically.

Pricing

Price
£2,000 to £600,000 a unit
Discount for educational organisations
Yes
Free trial available
No

Service documents

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 sales@rgrid.tech. Tell them what format you need. It will help if you say what assistive technology you use.