By Allison Proffitt

October 19, 2023 | BARCELONA—Clinical Research News named the 2023 Best of Show Award winner at SCOPE Europe yesterday, honoring Anju Software’s TA Scan product and its expanded diversity dataset.

The Best of Show awards program at SCOPE Europe invited exhibitors to enter new products for review and community voting. Besides the winning entry, seven new product finalists were exhibited on the exhibit hall floor: Greenphire’s ClinCard and GreenSpace; IQVIA’s IRT Supply Automation Value Engine; Medidata’s Diversity Program; Medidata Detect; Science 37’s Metasite Rescue; Sony Network Communications Europe’s mSafety Digital Biomarker Solution; and Stitch’s Stitch v1.23.

The more than 500 attendees at the Summit for Clinical Ops Executives event were invited to vote after viewing the new products in person. The community chose Anju’s TA Scan diversity dataset as the winner.

“TA Scan is a clinical and medical intelligence business tool to make data-driven decisions, mostly in the space of clinical operations and medical affairs,” explained Elke Ydens, Associate Director of Business Solutions at Anju Software. “It can be used for site identification, feasibility assessment, enrollment projections, KOL or PI identification.”

The new feature in TA Scan that garnered recognition is diversity or demographic data from several European countries—UK, Spain, and France. These public datasets reflect census data available for each country. The UK includes population-level diversity data; Spain and France include public demographic data according to each country’s own privacy regulations. “For instance, in the UK we have 15 different ethnicities mapped out. You can really find not just ‘Asian’ but Asian subpopulations,” Ydens explained by way of example. “France and Spain don’t have that data available, but they do have age or whether [an individual is part of a] foreign or local population.”

The new diversity and demographic information is integrated with TA Scan’s existing site and principle investigator database, enabling Anju’s global user base to better select sites and set appropriate diversity criteria for sites they are already working with.

The diversity and demographic dataset will be updated as frequently as each country updates their population data, Ydens said, and the company is actively expanding the list of countries for which data are available. She declined to share specifics on which countries to expect next, but she did say new country data is being added now.

“The way we prioritize the countries is that those countries that have [a measurable] level of diversity, but secondly, the most used based on our client feedback, or what we expect to see in the market,” she said.

Finalist Field

New products eligible for the Best of Show competition must have been released or significantly advanced in the past year. The community was instructed to vote for the finalists they expected to measurably improve workflow or capacity, advancing research.

Anju Software's TA Scan v1.4.0
https://www.anjusoftware.com/ta-scan/ 

Equitable patient representation in clinical trials has been difficult to achieve. Data strategies ensuring the inclusion of diverse participants are becoming increasingly important. Nowadays, however, there is a lack of robust and reliable data on race, ethnicity, and socio-economic characteristics on a global scale. Meet TA Scan, a cloud-based clinical intelligence solution that aggregates and connects global clinical trial, presentation, publication, and many other data sources from the public domain into a single, intuitive database. Our accurate data allows users to make more informed decisions around their study designs, diversity strategy, feasibility, and site/investigator/KOL identification strategies. Despite limitations in global diversity data, there is still a broad range of high-quality data that can be consolidated, standardized, and visualized to support streamlined diversity and site identification strategies. Our teams manage complex data consolidation so users can extract global insights to drive clinical trial equity and inclusion. In the past year, TA Scan expanded its fully integrated demographic and diversity data to include population and patient data from the US and European countries. TA Scan’s data and built-in analytics allow users to easily streamline global site/investigator/KOL selection and diversity strategies, by assessing experience levels and intelligence around competitive drugs and clinical trials together with exposure to diverse populations. Data can be filtered and visualized within the TA Scan application, exported for analysis, or alternatively delivered via our API. Moreover, in our Data-as-a-Service offering, our experts can provide sponsors and CROs with the required insights to support their site/investigator/KOL identification and diversity strategies.

Greenphire's ClinCard and GreenSpace
ClinCard: https://greenphire.com/participant-payments/
GreenSpace: https://greenphire.com/greenspace/

Greenphire was founded on the belief that clinical trial participants should never cite structural barriers as a reason for dropping out, nor should enabling access come at the expense of creating additional administrative work for site staff. The Greenphire patient convenience suite enables sponsors and CROs to deliver engagement solutions across their entire trial geographical footprint, which removes financial and logistical burdens and increases patient access. In 2023, Greenphire dramatically expanded its patient-centric services to include: Financial Reimbursement: Greenphire completely revamped our participant payment capabilities, introducing lower costs and regionally-preferred payment modalities along with participant choice. Our ClinCard solution now covers 75 local bank rails; funding currencies in GBP, Euro, CAD and US Dollars; and provides cards, direct deposit, regionally-preferred eWallets, and email-to-Money. Mobile Access: Greenphire launched GreenSpace, a digital patient experience available on the web and via an app for trial participants and their caregivers. The app offers the ability to check balances and coordinate travel as well as powerful engagement tools including surveys, multi-media insights and ePRO/consent. The platform is available in 29 languages, and puts control in the hand of the patient. Travel Concierge: Greenphire has offered localized travel support (ground, air, lodging, visas, etc.) but now it has been expanded to offer coverage in 47 countries, including in-country support in Belgium, France, Germany, Italy, Poland, Spain, Sweden, the UK and with new markets including Japan, Portugal and Ukraine. In fact, 73% of our travel volume occurs outside of the US.

IQVIA's IRT Supply Automation Value Engine
https://www.iqvia.com/solutions/technologies/orchestrated-clinical-trials/patient-engagement-suite/interactive-response-technology

By utilizing real-time data, the creation of SAVE greatly enhances IQVIA’s current IRT platform, driving simple, automated configuration of intelligent supply chain optimization – reducing risk, waste, cost and effort. By implementing SAVE, clinical trial sponsors can achieve substantial savings, up to $20,000 per month, on investigational product (IP) and shipping costs. SAVE also minimizes the risk of errors, improves efficiency, and frees up valuable resources for clinical teams.

Medidata's Diversity Program
https://www.medidata.com/en/solutions/diversity-in-clinical-trials/ 

The Medidata Diversity Program comprises a suite of innovative and industry-leading solutions. These include Medidata AI Intelligent Trials, myMedidata Registries, the Medidata Patient Insights Program, and Medidata’s partnership with Circuit Clinical – a national network of sites focused on diverse patient populations with localized investigators, trained on Medidata decentralized clinical trial technology. Each of these solutions has been thoughtfully selected and bundled together to empower sponsors and CROs to weave diversity into every aspect of their trial strategy. Through the patient insights program, sponsors and CROs can co-create the most patient-friendly and inclusive protocol with insights from diverse patient advocates. Leveraging the vast repository of industry-wide, site-level data, Medidata Intelligent Trials enables sponsors and CROs to identify sites that perform well operationally and have historically been successful in enrolling diverse patients. Meanwhile, Circuit Clinical’s site network opens doors for sponsros and CROs to tap into a comprehensive site network, making it easier for underrepresented groups to participate in clinical trials. Lastly, myMedidata Registries foster continuous patient engagement pre-trial and post-trial to address the disparity in clinical trial access and awareness. From the inception of trial design, through site selection, decentralization, and patient engagement, the Medidata Diversity Program offers a suite of tools that aims to cultivate diversity and ensure more equitable clinical trials.

Metadata's Detect
https://www.medidata.com/en/clinical-trial-products/clinical-operations/rbqm/centralized-statistical-monitoring/

Medidata Detect is a modular, interconnected, single sign-on, and cloud-based clinical software for data quality and risk monitoring. Detect aggregates and analyzes data from many sources to provide a unified picture of the risk inventory, patient journey, site performance, and overall trial health. Many different types of clinical data can be automatically integrated in one place, including sensors, eCOA, central lab data, EDC, and safety data, to drive unified, configurable workflows for multiple operational users. Detect activities include initial and ongoing risk planning and assessment, planned risk monitoring via KRIs, QTLs and targeted analyses, anomaly detection via ML-driven checks, automated data cleaning using preset data listings and bulk query management, and safety reviews with narrative patient profiles. Trends, insights, and risks are surfaced in intuitive visuals and dashboards that are fully integrated with an issue management interface. Detect analyses are powered by machine learning, AI, and intelligent process automation to significantly improve clinical research efficiency. In 2023 Medidata Detect released several significant upgrades to its functionality including: -AI data reconciliation which improves data quality by enabling complex data reconciliation and anomaly detection powered by AI that increases efficiency and detects potential issues earlier. -Clean Patient Tracker allowing data managers to track patient cleaning status in real-time dashboards greatly reducing time and effort of data cleaning -Libraries & Templates enabling easy access to saved, reproducible KRI and Listing templates significantly reducing time to analysis.

Science 37's Metasite Rescue
https://www.science37.com/virtualsite

At Science 37, our mission is to accelerate clinical research by enabling universal trial access for patients and providers, anywhere. We pioneered the virtual site (the Science 37 Metasite) and continue leading the industry, enabling faster, more inclusive, patient-friendly trials. Science 37 launched the Metasite Rescue as an accelerated virtual site that can be deployed in under 12 weeks for slow enrolling studies, delivering the recruiting power of ~20 sites in a single virtual clinical trial model. With in-house medical and operational experts who oversee trials, Science 37 leverages a unified set of proprietary technology, people, and processes to generate greater consistency and high-quality data, facilitating the end-to-end trial. A mobile healthcare team and/or community-based clinics can also be integrated where vitals or other services are involved. Medical professionals travel to a patient’s home to perform services, while community-based clinics support study procedures such as diagnostic imaging, which cannot be performed in a patient’s home.

Sony Network Communications Europe's mSafety Digital Biomarker Solution
https://www.sonynetworkcom.com/msafety

With the mSafety Digital Biomarker Solution from Sony, any researcher can begin collecting, managing and exporting health data for their remote trials. The off-the-shelf solution includes dedicated wearables, a web interface for control over trial devices, a cellular connectivity service, access control management and APIs for solution integration.

1. Data measurement:

• Collects raw or augmented data from wrist-worn wearable sensors.
• Real-time data transfer to the cloud via LTE-M technology.
• Optimized for uninterrupted data collection with minimal user interaction.

2. Data access and management for researchers:

• Web console with dashboards for data access, visualization, and interaction.
• Supports large-scale data exports via REST API integration.
• Configurable for clinical trials including large-scale projects multi-clinic projects.

3. Adherence monitoring:

• Measure participant adherence through continuous sensor data and device state tracking.
• Detect when trial protocols are not followed and take action, e.g. send reminders to the participants.
• Unbiased participant information display (time, battery, network status).

4. Remote device management:

• Firmware Over-The-Air (FOTA) updates for effortless, remote updates.
• Remotely assign and configure applications, sensors, frequency and range for maximum flexibility.

5. Device application:

• Designed for ease of use and performance.
• Requires minimal user input, primarily charging. (Does NOT require any accounts, logins, settings, etc.)

6. Sensor settings:

• Integrated state-of-the-art device sensors, including photoplethysmogram (PPG), 3-axis accelerometer, and 3-axis gyroscope.
• Accelerometer range: ±2g to ±16g; Gyroscope range: ±125deg/s to ±2000deg/s. Both Inertial Measurement Unit (IMU) sensors can individually be set to frequencies from 16Hz up to 128Hz. Frequencies between 16Hz and 32Hz included in standard subscription.

Stitch v1.23
https://www.stitchhealth.co

Stitch is the in-study engagement and feedback platform for research sponsors. Stitch offers applications for patients, sites and sponsors. For patients Stitch is designed with patients to improve their experience of clinical trials and reduce the burden of participation - The app is a website that patients can visit on their computer, tablet or smartphone - It provides information about the trial, including visit details and appointment reminders - It gives patients the opportunity to provide feedback on their trial experience For sites Stitch saves sites time by automating existing processes and workflows - Visit windows, defined by the protocol, are shown to site staff when they are scheduling visits. - Contextual reminders are sent to patients before every visit to support protocol compliance - Participants can confirm their attendance, which reduces missed visits and helps busy site staff manage their time For Sponsors - Study team users can see experience data from their trial participants, in real time. - Visibility into which research sites give participants the best experiences - Understand the patient journey and identify where their experience can be improved Use learnings from each study to inform and optimise future study design This data is used to optimise trial design, engage patients, improve protocol compliance, and ultimately to speed up studies.