Cloud- Based Clinical Trial Management For Medical Imaging
Cimar is the secure and seamless solution for medical image upload, sharing, and de-identification for clinical trials. Used for over 700+ trials worldwide, the platform dramatically reduces time to implement and cuts costs by improving delivery speed and reducing submission errors. Instantly scale to sending sites while maintaining submission integrity.
- End-to-End Medical Imaging Clinical Trial Management Workflow
- End-to-End Research Management - Cloud-Based Ingestion, Analysis, Distribution
- Custom upload fields (e.g. IDTF)
- Validation rules & QC workflow
- KOL workflow and eCRF forms
- Downstream routing rules
- Tag and Pixel Anonymisation - Rules Based and/or AI Based
- Remote Access to Imaging - Zero-footprint, FDA approved viewer
- Simple to use, secure Web-Uploading technology
- New AI Stack - Horizontally Scalable AI Service
- Reduce Trial Set-Up Time - from weeks to days
- Huge reduction in cost for trial management
- Cut Costs, Increase Trial Efficiency & Drive Transparency for Sponsors
- Add new sending sites with just a few clicks
- Quickly customise to your specific trial needs
- Integrates with existing tools and existing workflows
- Scalable Cloud Archive - CD-Elimination, On-Site Archive Risk elimination
- Unify Imaging Data - Organise Imaging Data across all projects
- Provide roles-based access to collaborators
- AI Parnerships
£5.00 per unit
- Education pricing available
- Free trial available
- Pricing document
- Skills Framework for the Information Age rate card
- Service definition document
- Terms and conditions
Mr Howard Jenkinson
|Software add-on or extension||Yes, but can also be used as a standalone service|
|What software services is the service an extension to||
PACS - Seamlessly connects to any Vendor's PACS via gateway technology.
RIS - Cimar is fully compatible with all RIS and HL7 message exchanges.
ELECTRONIC HEALTH RECORD / PATIENT PORTAL - API embeddable imaging layer inside 3rd party applications.
|Cloud deployment model||
Service is provided on a 99.8% uptime.
Maintence windows are rarely required but are advised well in advance if ever needed.
|Email or online ticketing support||Email or online ticketing|
|Support response times||
Supplier Level 1 support hours of operation are 8am - 8pm (GMT), 7 Days per week.
Supplier Level 2 and 3 support hours of operation are Monday through Friday, 8 am to 8 pm (GMT) excluding national UK holidays.
After hours escalations to Level 2 and Level 3 support are available as needed.
|User can manage status and priority of support tickets||Yes|
|Online ticketing support accessibility||None or don’t know|
|Phone support availability||9 to 5 (UK time), Monday to Friday|
|Web chat support||No|
|Onsite support||Yes, at extra cost|
Cimar’s approach to support our client's administration of their cloud account.
First Level Support
1. Verifying entitlement to receive support.
2. Taking the initial call from the Subscriber, and tracking the problem until its resolution.
3. Assigning an initial severity level to the problem.
4. Checking list of known problems and workarounds.
5. Implementing resolution to known problems or assisting Subscriber with workaround where feasible.
6. Isolating, identifying, and reproducing unknown problems reported by Subscriber.
7. Researching a workaround or other solution to an unknown problem.
8. Escalating the issue to Second Level Support if unresolved at this level.
9. Advising Subscriber of status changes related to reported problems.
Second Level Support
1. Confirming the severity level of the problem.
2. Investigating and analysing the problem.
3. Providing resolution of problems with known corrections or workarounds.
4. Escalating an unknown problem to Third Level Support (Engineering).
5. Delivering hot fixes to Subscriber.
6. Providing assistance with more complex installation/configuration problems.
7. Advising Subscriber of status changes related to their reported problem.
|Support available to third parties||Yes|
Onboarding and offboarding
Cimar provides an extensive library of on-line user support material, and provide 'train-the-trainer' knowledge transfer as required. Additional training services can be provided upon request, including online web-event tutorials by arrangement.
Cimar also assists in providing custom support material for our clients that can be accessed by all users via our clients intranet, or login to Cimar's service.
|End-of-contract data extraction||
Data can be extracted or migrated at any time from Cimar via Cimar's Gateway - directly to any DICOM node or suitable receiving system.
Large volumes (TB) are best migrated by arrangement with Cimar, where a cost for such migration will be quoted, dependant on volumes and our clients requirement complexity. e.g. to physical drive/NAS/SAN, or if we are required to transcode data to specific syntaxes for import into other systems. Numerous variables can apply, and Cimar is always committed to making migration as painless as possible for our clients.
Since Cimar is entirely Vendor Neutral, we are able to export/migrate data we host - in formats our clients require - that match other DICOM 3.0 compliant systems.
Depending on the workflow Cimar has been used for, we agree with our clients what data migration needs should be accommodated.
In some workflow scenarios, Cimar holds only copy images, and their retention may not be required. In other workflows, we are the core archive - in which case all images will most likely require migration to another system.
Users continue to use Cimar as normal throughout the termination period, whilst planning and execution of the transitional process between systems of their choice occurs.
Using the service
|Web browser interface||Yes|
|Application to install||No|
|Designed for use on mobile devices||Yes|
|Differences between the mobile and desktop service||The Cimar cloud solution and mobile apps (IOS, Android) run on smart mobile devices (phone and tablet) with suitably constrained diagnostic functionality.|
|Accessibility standards||None or don’t know|
|Description of accessibility||Viewing studies, sharing studies, downloading studies, workflow management, security, roles and permissions and full administration of the platform is accessed via the zero-footprint Cimar user interface. All Cimar's services are also accessible via 3rd party applications via API, including Electronic Health Records, Radiology Information Systems and any other applicable applications|
|Accessibility testing||N/A - No direct testing with assistive technology has been completed by Cimar. Where and how our cloud is integrated in an assistive environment, depends on the development scope and implementation remit of those apps and programmers that elect to embed our cloud. Native access to our cloud is entirely through browsers, and the functionally in these (assistive functions, configuration and settings), are features of the browsers themselves, rather than Cimar's PACS UI.|
|What users can and can't do using the API||
Cimar provides a complete RESTful API, featuring all functionality as embeddable components. This ranges from a raft of image harvesting, manipulation, transcoding and viewing functionality, to web diagnostic reporting, VR support, and RESTful cloud archiving and recall.
All API integration is via JSON and web-hooks. Integration can either via synchronised encrypted hyperlink exchange, or as native JSON calls between platforms. we support AD and SSO via Ping identity services.
Embedded imaging functionality can be achieved in as little as a few hours, or complete integration at a granular level typically takes a few weeks coding.
Cimar can also be embedded using simple hyperlinks to Cimar hosted image harvesting and dynamic viewing services - including a complete, customisable Second Opinion Portal. All User Interface presentation can be customised and honed to match applications into which Cimar is embedded.
|API documentation formats||
|API sandbox or test environment||Yes|
|Description of customisation||
Cimar's Service interface can be extensively customised.
The User Interface can be adapted to include custom terminology, other languages, CSS colour schemes, white-labelled branding and URL access.
Unlimited custom fields can be added, and if required, auto-mapped to DICOM tags.
Smart rule-logic can be customised to accommodate IF/ELSE logic within workflows and such rules can be content-aware using Cimar’s Machine Learning features to automate and transcode study, PHI or custom field content.
The platform is designed to enable clients to design and create their own bespoke workflows, to the extent that user roles, functionality permissions, rules based logic and automated tasks can all be configured to match existing or new operational practices as required.
|Independence of resources||
Our host platform is hosted with UK Cloud and is built on a dynamically expandable architecture where load balancing manages system performance and on-demand resource availability. Storage is elastically expandable, as is application and Database layer infrastructure running as a virtual environment.
Object or Block storage architectures are available as required.
|Service usage metrics||Yes|
|Metrics types||Dashboard usage graphs are available as permissable role functionality. Detailed study reports can be downloaded including custom field content and study metrics. Audit trails at study and user activity levels can be viewed where role profiles permit, and similarly exported as structured data reports.|
|Supplier type||Reseller providing extra features and support|
|Organisation whose services are being resold||Ambra Health inc.|
|Staff security clearance||Other security clearance|
|Government security clearance||Up to Security Clearance (SC)|
|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||Complies with a recognised standard (for example CSA CCM version 3.0)|
|Penetration testing frequency||At least once a year|
|Penetration testing approach||‘IT Health Check’ performed by a CHECK service provider|
|Protecting data at rest||
|Data sanitisation process||Yes|
|Data sanitisation type||
|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||
Data can be exported any time via Cimar's Gateway - directly to any DICOM or VNA node or suitable receiving system.
Large volumes (TB) are best migrated by arrangement with Cimar, where a cost for migration will be quoted, dependant on volumes and requirement complexity. e.g. to physical drive/NAS/SAN, or if we are required to transcode data to specific syntaxes for import into other systems. We can script to match/de-dupe/morph studies during export enabling easy synchronisation between our platforms connected to our Service.
Numerous variables can apply, and Cimar is committed to making migration a painless excercise for our clients.
|Data export formats||
|Other data export formats||
|Data import formats||Other|
|Other data import formats||
|Data protection between buyer and supplier networks||
|Data protection within supplier network||
|Other protection within supplier network||
We provide patented Split/Merge protection for all data within our network. Images at rest are stored without any identifyable PHI, which is held separately in an encrypted database. United Image and PHI data only occurs in system memory, either at the time of reciept or request. In addition all data carried to and from our service is either over N3 exlusively, or over HTTPS (256 bit AES or DES encrypted).
Cimar is also accessible as an Internet service, but only as an HTTPS protected connection. this can be through N3's internet Gateway or externally - e.g. by patients.
Availability and resilience
Service Level (System Level Uptime) is determined as a percentage of time in a month that the system is available and functioning properly as defined below. Cimar will provide the uptimes listed in the chart below. Recurring maintenance windows, scheduled downtime, and emergency updates are excluded from the system level uptime percentage calculation. Additionally, any downtime caused by the Subscriber environment is not considered downtime for any component of the Cimar application. (i.e. Subscriber internet connection is down, power outage at Subscriber site, etc.)
System Component/Function Service Level (System Uptime): Application Suite 99.9 % Gateway 98%
Regular maintenance windows are agreed as needed with our clients.
|Approach to resilience||Available on request. This would be co-provided with UK Cloud.|
|Outage reporting||All of these can be configured if required.|
Identity and authentication
|User authentication needed||Yes|
|Access restrictions in management interfaces and support channels||Customers have the option to raise a support request via telephone or email. Cimar authenticates the enquirer's identity by validating known phone numbers and asking them for specific characters within their pre-agreed memorable word where applicable to client protocols. Application administrative access is only available to those users, that our clients permit. this is only application-level admin, and no deeper system access is possible. Such access is used to configure the client's own account settings, which is entirely separate from all system and infrastructural configuration settings.|
|Access restriction testing frequency||At least once a year|
|Management access authentication||
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||User-defined|
|Access to supplier activity audit information||Users have access to real-time audit information|
|How long supplier audit data is stored for||User-defined|
|How long system logs are stored for||User-defined|
Standards and certifications
|ISO/IEC 27001 certification||Yes|
|Who accredited the ISO/IEC 27001||QMS - 303492019|
|ISO/IEC 27001 accreditation date||05/04/2019|
|What the ISO/IEC 27001 doesn’t cover||Aspects of our standard operating procedures that are not included or integral to our ISO27001 IMS|
|ISO 28000:2007 certification||No|
|CSA STAR certification||No|
|Other security certifications||Yes|
|Any other security certifications||
|Named board-level person responsible for service security||Yes|
|Security governance certified||Yes|
|Security governance standards||ISO/IEC 27001|
|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||Cimar uses the Github System for configuration management of source code. All application change development is managed on a siloed principle, before deployment to a complete UAT environment with full roll-back capability. A full assessment is comprised of tests for all known web application vulnerabilities using both automated and manual tools based on the OWASP test principles. Once a new releases resilience and performance is validated, security and stress tested, deployment to live cloud is implemented.|
|Vulnerability management type||Supplier-defined controls|
|Vulnerability management approach||Cimar has a documented vulnerability management policy and process with Ambra Health, which have been implemented, maintained and assessed in accordance with the guidance from ITIL v.3. Where technically possible, real-time updates and status reports are identified and sourced from credible sources. For other systems and software, assigned Ambra personnel have responsibility for regularly reviewing technical forums and specialist groups to promptly identify and evaluate any emerging patches or updates which require technical attention or preventative action.|
|Protective monitoring type||Supplier-defined controls|
|Protective monitoring approach||In accordance with best practice from the National Cyber Security Centre, and Cyber Essentials, Cimar thoroughly protects its applications and systems at the hypervisor level and below. Our approach to protective monitoring includes realtime checks on malicious threats, Portscan attacks, evidence of unauthorised access to privileged accounts and anomalous occurrences that are not related to specific applications on the host, suspicious activities at a boundary, network connections and the status of backups, amongst others. All alerts are immediately notified to us for prompt investigation.|
|Incident management type||Supplier-defined controls|
|Incident management approach||Incident Management is managed through our own/Ambra policies which conform to the requirements of 21CFRPart11 and as detailed in our ISO9001 procedures. Our Incident and security monitoring policies define the chronological processes and remedial activities in the event of a detected threat that requires action above our systems automated threshold of control. Such action is reported through a predefined command/responsibility structure, and all such reports are recorded.|
|Approach to secure software development best practice||Conforms to a recognised standard, but self-assessed|
Public sector networks
|Connection to public sector networks||Yes|
|Price||£5.00 per unit|
|Discount for educational organisations||Yes|
|Free trial available||Yes|
|Description of free trial||
Full access to a trial account including all available functionality.
By negotiation, inter-system (PACS, RIS, EMR) Gateway communications can be provided.
Trials are limited to PoC principles for our clients