SMART IMAGING FOR ACCELERATED CLINICAL TRIALS

[email protected] | www.perspectum.com | US: (+1) 857 321 8675 | UK: (+44) 1865 655325

MKT100 - 2.0


MKT100 - 2.0

• Quality checks• Archival• Central image processing • Report generation• Quick turnaround time

• Customized imaging review charter, eCRF and site manuals

• Communication plans with CRO and sponsor

• Data portal set-up & configuration

• Protocol design or review in partnership with sponsor

• Access to key sites and medical expertise

• Rapid activation of imaging centres, covering metric standardisation

• On-site set-up for MR tech & CRA training on all metrics

• Data portal set-up & configuration

• Data reconciliation• Query resolution• Write up of imaging

methodology and results in Clinical Study Report

• Imaging Data Archival

• SAP consultation & development

• Generation of TLFs• Data reports for interim

reviews & Clinical Study Report

STUDY START-UP STUDY PROCESS & DOCUMENT DEVELOPMENT

IMAGE ANALYSIS & REVIEW

• Site oversight and management• Project management support

throughout the study including imaging oversight visits

• Monthly reports and subject tracking

• Data quality reviews and monthly analytics on site performance

• Secure data collection and storage

• Data clean-up, quality control and reconciliation

• Integration, tracking, and communication of trial information

STUDY CLOSE-OUT

A TURN-KEY IMAGING SOLUTION FOR YOUR CLINICAL STUDY

BIOSTATISTICS

IMAGING STUDY MANAGEMENT

DATA MANAGEMENT


MKT100 - 2.0


MKT100 - 2.0

300+sites worldwideEquipped with our multiparametric MRI technology, LiverMultiScan

60,000+scans delivered

100,000individuals’ imaging data will be managedas part of the UK Biobank – the world’s largest, multi-site imaging study acquired over 5 years.

$140M+ grant fundingPerspectum, together with our collaborators, have won over $140M in grant funding for clinical studies in liver disease.

30+ clinical trials

as an imaging provider

WHAT WE OFFER:OUR EXPERIENCE

ACCELERATING YOUR CLINICAL TRIALWITH OUR LEADING IMAGING SERVICES

We focus on solutions for the identification and monitoring of liver disease — including metabolic, autoimmune and cholestatic — cancer, diabetes, irritable bowel disorder delivered via software as a service (SaaS).

We combine our quantitative, non-invasive image analysis service, operational excellence, therapeutic expertise and innovative technology to enable the delivery of superior clinical data for improved decision-making and accelerated drug development.

Patient-friendly, cost-effective screening tools are critical for sponsors that want to quickly enroll, enrich, and monitor their clinical trials at every phase.

Our non-invasive imaging biomarkers can effectively stratify patient populations, maximizing the enrollment of patients most likely to benefit from treatment and reducing the time and cost of recruitment.

They can also provide quantitative metrics, which are suitable for early efficacy detection and long term monitoring of treatment effects during interventional trials.

The metrics are standardized across MRI machines, enabling multi-site studies with repeatable and reproducible results.

We provide end-to-end data management, and our extensive experience in clinical trials means we can overcome operational issues and bottlenecks that you may experience.

De-risk your trial design

Reduce timeline to approval

Non-invasive patient stratification

Speed up enrollment & reduce drop-out

Early efficacy and safety indication

Lowerscreen fail rate

Enhanced trialenrichment

Long-termpatient monitoring


MKT100 - 2.0


MKT100 - 2.0

INTEGRATED SOLUTIONS OUR QUANTITATIVE ANALYSIS SERVICES

Data is processed and reviewed by our imaging and clinical

specialists

Report sent to physician via secure

interface

1

2

34

5

RAPID ANALYSIS

Quick non-contrast, hardware agnostic MR

abdominal scan

Data sent to our Amazon hosted Cloud

servicePhysician uses report

to assess patient liver health

Sponsor has visibility of study and blinded

results from controlled service

We receive raw images acquired by our trained imaging centers and post-process them using proprietary artificial intelligence and machine learning algorithms to produce quantified metrics of liver and metabolic health. All images are checked for quality and those that do not pass are sent to our in-house MR Applications and MR Physics teams for rectification. Every report generated by our Core Lab undergoes a review process prior to return.

The Perspectum Portal integrates the core lab data management across our vendors into Perspectum’s central imaging service, providing a single platform for access to data and results.

Our central imaging Quantitative Analysis Service is ISO:27001-compliant.

High-quality image acquisition, interpretation, and integration is crucial for the success of a clinical trial. Perspectum delivers a comprehensive range of integrated services, tailored to fit study requirements. Accelerate your clinical trial with our leading medical imaging services.

INTEGRATED SOLUTIONSOUR MEDICAL IMAGING SERVICES

An unparalleled service for clinical studies in liver disease — including metabolic, autoimmune and cholestatic — cancer, diabetes and IBD.

Heart• LV Function• RV Function• LV Mass• LV Wall Thickness• Diastolic Function

Aorta• Distensibility• Diameter• Wall Thickness • Pulse Wave Velocity

Colon• Endoscopy• Digital Pathology• MR Enterography

Body Composition• Visceral Adipose Tissue

(VAT)• Subcutaneous Adipose

Tissue (SAT)• Lean Muscle Mass• Muscle Fat Infiltration (MFI)

Liver Fat • Fibroinflammation• Iron Load• Volume• Liver Stiffness• Biliary System Metrics

Spleen• Fibrosis• Volume• Portal Hypertension

Pancreas• Fibrosis• Pancreatic Fat• Volume

Kidneys• Fibrosis• Diffusion • Blood Oxygenation• Volume• Cortex Metrics• Medulla Metrics

MKT100 - 2.0


MKT100 - 2.0

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No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system or translated into any language or com language, in any form or media without the prior written permission of Perspectum Ltd.

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