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LINKVERSE CLOUD IMAGING WORKFLOW

Linkverse Cloud Imaging WorkflowTM, provides a secure and fast, regulatory compliant platform for biomedical data (images, videos and data) management, de-identification, submission, transmission, archiving and distribution from Clinical Sites to central archiving, reading panels and clinical trial team.

BIOMEDICAL DATA

Linkverse Cloud Imaging WorkflowTM is able to manage the following list of biomedical data:

• Magnetic Resonance
• Computerized Tomography
• SPECT, SPECT/CT
• PET, PET/CT
• Ultrasound Imaging/Video
• Endoscopy Imaging/Video
• Electrocardiography
• Radiography
• Mammography
• X-Ray Angiography
• Medical Photographs
• Whole Slide Microscopic Images

CLOUD IMAGING WORKFLOW MODULES

1.SUBMISSION MODULE

Linkverse Cloud Imaging WorkflowTM Submission module allows to interactively block and solve errors at the investigator site before data submission, thus reducing the number of queries related to imaging. It automatically will:

• Check that the imaging acquisition parameters are compliant with the study protocol by Checking for specific and dynamically customizable ranges
• Check for missing information, series, image orientation, etc.
• Filter useless contents and send only protocol related images
• Determine longitudinal checks between different visits to enforce time constraints required by the protocol
• Send real-time automatic alerts such as warnings or event notifications to people involved in the Clinical Study
• Do Artificial Intelligence checks on Biomedical Data with Linkverse PrimagaTM, such as motion artifacts detection, correct subject positioning detection, and more

2. DE-IDENTIFICATION

Linkverse Cloud Imaging WorkflowTM de-identification module will completely and automatically remove personal information, such as:

• Personal data contained in metadata embedded in Biomedical Data, such as the removal of DICOM tags
• Personal data contained in Biomedical Data, such as images or videos superimposed text on both DICOM and non-DICOM contents
• Personal data contained in Biomedical Data itself, such as faces in images or videos with automatic detection and masking using Linkverse PrimagaTM

3. TRANSMISSION

Linkverse Cloud Imaging WorkflowTM transmission module allows the delivery of biomedical data in an automated, fast, secure and safe way. The relevant features are:

• Far more efficient, cost-effective and less time-consuming than traditional methods
• Takes advantage of all the available transfer technologies (fiber optics, xDSL, 3G, 4G, WiFi, etc.)
• Reliable and resilient to internet network outages
• Can transfer very big data loads thanks to the embedded transfer automatic monitoring system that manages transfer in difficult conditions
• Zero-effort solution for users at clinical sites, since everything is managed automatically, enabling better protocol compliance
• All the transport progresses are tracked in Linkverse SnowflakeTM, the Linkverse Dashboard module
• Alerts and notifications by e-mail are configurable for every transport workflow step

4. ARCHIVING

Linkverse Cloud Imaging WorkflowTM Storage module provides central storage space for clinical trial images as-a-service, which includes the following features:

• Regulatory Compliant
  Provides a validated platform, compliant with regulatory requirements
• Secure
  The infrastructure is constantly maintained and upgraded
• Data Safety
  Storage space is constantly backed up with on-line, on-site, off-line and off-site policies
• Cost Effective
  There is no requirement of capital investments
• Unlimited Capacity
  Storage space is virtually unlimited
• Precise Budgeting
  Storage costs can be set up very precisely at the beginning of the clinical trial
• Multi-Study Capability
  As a part of Linkverse Cloud Imaging WorkflowTM, the Linkverse Storage Module can be used for any clinical trial that using this technology thereby creating a a common regulatory compliant storage solution
• Executive Dashboard for Study Management
  The Storage module is integrated with the Dashboard module, thus allowing to be browsed at any time and searched with many parameters
• Long Term Data Storage
  Retention policy is very flexible and can be modified at any time

5. DASHBOARD

Linkverse Cloud Imaging WorkflowTM Dashboard module is Linkverse SnowflakeTM, a key element in the architecture, providing a single point of access for any imaging and video needs, like reviewing, processing, tracking and much more.

• Allows tracking of all Linkverse Cloud Imaging WorkflowTM activities
• Allows reviewing of images and videos on-demand and online
• Collects all processing or reviewing results
• Graphically presents all relevant data to provide maximum control of key data metrics
• Allows Quality Checks on images, videos and metadata
• Restricts access to data based on the provisioned security policy, defined for single to group of users
• Can includes pluggable images, videos and data viewers for a variety of imaging reviewing needs

6. "EDC" AND "CTMS" INTEGRATIONS

Linkverse Cloud Imaging WorkflowTM EDC/CTMS Integration feature provides bi-directional integration with both EDC and CTMS Systems:

• DICOM and non-DICOM metadata can be used to create relationships with EDC/CTMS data, this allows to build integrated workflows with data acquisition and submission and further processing, e.g. smart and quicker selection of subjects and visits
• DICOM and non-DICOM metadata are submitted together with images and can be batch loaded in real-time to EDC/CTMS to complete visit information
• The Dashboard Module can receive real-time information from EDC/CTMS and can show integrated information to complete images with clinical study data

Integration with EDC/CTMS allows:

• Reduction of site errors and queries
• Increased study compliance
• Lower data entry costs
• Automatically check the reconciliation of images submissions with clinical study events and subjects

Linkverse provides products to acquire Biomedical Data specifically designed for Clinical Studies:

1. Black-Box

Linkverse Black-BoxTM is a book-sized device to be placed at a Clinical Site that takes care of automatically transferring Biomedical Data.

Biomedical Data is provided to the Linkverse Black-BoxTM in the following ways:

• DICOM or standard images and videos, through the local network
• DICOM or standard images and videos, through external memories (USB flash, CD/DVDs)
• DICOM or standard images and videos, through external encrypted memories (FIPS 140-2 compliant)
• Study-specific Biomedical Data, with custom integrations

By providing Biomedical Data to Linkverse Black-BoxTM, Linkverse Cloud Imaging Workflow TM is activated.

Transmission can be accomplished using a broad range of connection options: 3G/4G mobile connections, WiFi, LAN, etc.

2. Face Atlas

Linkverse Face AtlasTM is a device for capturing face photographs of study subjects.

• Small Footprint Device
  Linkverse Face AtlasTM main device is a cart with a footprint of 20x20 inch and comes with 2 wheels to be moved around easily. It can be easily placed against a wall when not used and can be quickly positioned in front of the patient when needed.
• Interactive Interface
  Face Atlas comes with a bundled Tablet with a pre-installed App to control the acquisition, review, export and transmission processes interactively. The whole process is crystal clear step-by-step procedure that makes the workflow as easy as a finger tap. The Tablet is wirelessly connected to the cart.
• Integrated Modular Light Sources
  Face Atlas integrates several lighting modules allowing to capture in a single step up to 4 simultaneous pictures of the patient under different lighting conditions.
• Integrated Storage with Cloud Extension
  Face Atlas comes with an internal storage memory that can archive up to 1000 patient visits. Data can be encrypted and synchronized with a dedicated Cloud Storage area that virtually extends the storage space to infinite.
• Integrated Customizable Workflow
  Face Atlas makes the operator following a specific acquisition workflow to get information about the patient visit which then will be bundled with the data. The data to be collected, as well as the procedure to follow is fully customizable and allows to strongly reduce input errors and to maximise the acquisition process speed.
• User Selectable Internet Connection
  Face Atlas can be connected to the Internet using the Tablet. The provided tablet comes with 3G/4G connections as well as WiFi support and can be setup by the user on the local Internet link availablity.
• Connectable to Linkverse PrimagaTM
  Face Atlas can be connected to Primaga, the advanced image post-processing platform by Linkverse. This unlocks all the processing power and features of Primaga on the acquired contents.
• Connectable to Linkverse Cloud Imaging WorkflowTM
  Face Atlas can be connected to Linkverse Cloud Imaging Workflow™ for fast and secure image data routing in Clinical Trials. Moreover, users can take advantage of the centralized Snowflake dashboard that enables remote review of the acquired data. Cloud Imaging Worklows brings also the possibility to perform EDC systems integrations.
• Easy to use
  Face Atlas is very easy to use. To start using it Linkverse provides a full-featured on-site training or online interactive or non-interactive webinars.
• Security
  All data handling is performed with the highest security levels.
• Compliance
  Data Privacy HIPAA, Directive 95/46/EC, GCP, FDA 21 CFR Part 11, Eudralex Vol 4 Annex 11, FIPS 140-2, EN 60601-1 (can be in the patient range).

3. Video Replicator

Linkverse Video Replicator is a device dedicated to Clinical Studies that is able to record Endoscopy Video procedures in High Definition without any loss of quality, together with study specific annotations to allow remote review for central reading or quality assessments.

• Accepts a wide range of video signals
  Accepts any Standard Definition (SD) or High Definition (HD) signal: SDI, HD-SDI, 3G-SDI, HDMI, DVI, analog
• Lossless compression
  It is able to compress videos without any loss (original signal up to 4K 10 bit 4:2:2)
• State-of-the-art conventional compression
  Optionally, it is able to compress videos with lossy compression (H.264, H.265, etc.)
• Study-specific labelling
  It allows to perform study-specificy labelling, e.g. mark procedures timepoints, assign procedure labels, calculate timing between timepoints. It allows study-specific overlay to be displayed during Endoscopy procedure
• Data export
  Exports videos on external Solid State Disks (e.g. FIPS 140-2 encrypted disks). Videos can be submitted remotely using Linkverse Black-Box
• Compliance
  Data Privacy HIPAA, Directive 95/46/EC, GCP, FDA 21 CFR Part 11, Eudralex Vol 4 Annex 11, FIPS 140-2, EN 60601-1 (can be in the patient range).

Linkverse Biomedical Data Analysis platform is Linkverse PrimagaTM.

• Software as-a-Service analytics platform founded on machine learning
  Allows the delivery of Artificial Intelligence results instantly.
• Quantitative instead of Qualitative Analysis
  Makes comparable results, improves data meaning, allows data post-analysis and data mining.
• Artificial Intelligence
  Apply machine intelligence and learning algorithms to constantly improve, refine and deliver complex analytics and predictions.
• Data Capture Protocols
  Providing the expertise to maximize data collection and minimize data loss.
• Data Preparation
  Spatial transformation, color space transformation, data co-registration, data normalization.
• Automatic Image Segmentation
  Allows to reduce inter and intra rater variability, provides proven outcomes, provides cross quality check, and dramatically reduces the time-to-result.
• Image Features Detection
  Automatic detection of customizable image features, with multi-parameter cluster analysis.
• Image Quality Check
  Automatic and semi-automatic Quality Check, to detect image compliance to Clinical Study protocol, assess image quality grading, thus helping to have a consistent dataset.
• Results Feedback
  Batch loaded on EDC/CTMS, delivered securely by email or Linkverse SnowflakeTM.
• Compliance
  Data Privacy HIPAA, Directive 95/46/EC, GCP, FDA 21 CFR Part 11, Eudralex Vol 4 Annex 11

In years, Linkverse has greatly helped its customers in their critical processes that required specific deep knowledge in Information Technology applied to Medical Practice and Clinical Research.

Today Linkverse offers consulting services that make the difference especially when facing challenges regarding the management of Biomedical Data – such as images, videos and data – their integration with other products and their analysis.

Linkverse expertise allows to properly handle problems and opportunities, making the right decisions at the right time, turning them into success stories.

OUR SKILLS

Linkverse is provides its products and services to a broad range of companies in the Clinical Research field, for different applications and needs, as described below.

1. Biotech and Pharmaceutical companies

As Clinical Study Sponsors, Biotech and Pharmaceutical companies can get out the most from Linkverse technologies, to improve project governance, reduce time-to-market and take data quality to the next level. Moreover, Artificial Intelligence tools and Clinical Study specific applications can enable to achieve unprecedented results for their core business.

2. Contract Research Organizations

Linkverse platforms have been designed to be used across different projects to become an enabling technology for CROs across all its business. The governance and data quality improvement are definitely a game changer for CRO services to sponsors and could represent the distinguishing factor among the competitors.

3. Core Labs

Customers will definitely select Core Labs having the unique core competencies they are looking for. On the other hand Core Labs should face the challenges of collecting data from Clinical Sites, thus spending so much effort in non-core tasks. Linkverse platforms are designed to simplify data workflow to make Core Lab concentrating on its unique capabilities while providing a complete solution to the market.

4. EDC and CTMS companies

EDC/CTMS are defining the shape of the clinical data collection in Clinical Studies as technology is continuously changing. Linkverse platforms are offering a unique opportunity for such companies to provide convergent services that create a consolidated workflow of clinical data together with biomedical data. Such integrated platforms allow offering the most advanced, rich and complete solutions on the market.

Linkverse has a deep knowledge in the following therapeutic areas:

1. Oncology

Linkverse has a very strong product line to support Clinical Studies in Oncology for processing MRI, CT, PET and SPECT data for both data collection, analysis and workflow. See Cloud Imaging WorkflowTM and Biomedical Data Analysis.

2. Neurology

Linkverse has a very solid and experienced knowledge in Neurology, with a special focus on Dementia such as Alzheimer Disease (AD) and Parkinson Disease (PD), Multiple Sclerosis (MS) and much more. See Cloud Imaging WorkflowTM and Biomedical Data Analysis.

3. Gastroenterology

Linkverse has several solutions for acquiring and analyzing endoscopy videos in Clinical Studies, with a special focus on colo-rectal cancer (CRC) and inflammatory bowel disease (IBD). See Cloud Imaging WorkflowTM, Endoscopy Lossless Video Recorder and Biomedical Data Analysis.

4. Dermatology

Linkverse has developed a deep knowledge in supporting dermatology Clinical Studies, with a special focus on photography related capture and analysis. See Cloud Imaging WorkflowTM, Face Atlas and Biomedical Data Analysis.