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Best of Show Finalists Named for SCOPE 2024

By Allison Proffitt

February 7, 2024 | Dozens of companies are showcasing new products at next week’s Summit for Clinical Ops Executives, and 37 have been named finalists in the Best of Show People’s Choice Awards. The SCOPE community is invited to identify exceptional innovation in technologies used by life science professionals, voting on the most impactful new products of the year.

The awards competition is open to all SCOPE exhibitors, and exhibiting companies entered their products for consideration in advance of the event. Thirty-seven new products have been chosen as finalists. They will be recognized at the event and attendees are encouraged to explore the novel technologies and solutions firsthand in the exhibit hall and vote for the People’s Choice Award once the conference has begun. Please note, selection is not based on level of sponsorship or exhibit participation.

Finalists were chosen from all of the entries into the SCOPE Best of Show People’s Choice Awards by the Clinical Research News editorial team. Products must have been newly released or significantly improved since February 2023, and they must be available for purchase at the event.

Winners will be chosen by the SCOPE community voting during the event. Voting links will be available at finalists’ booths and throughout the event. Voting will open when the exhibit hall opens on Monday, Feb 12, at 9:35am Eastern and will close on Tuesday, February 13, at 1pm. 

Winners will be announced live at the event on the exhibit hall floor on Tuesday, February 13, at 2:00pm. 

The new products are listed below in alphabetical order by company name. The product descriptions below were submitted by the entering companies. Finalists include new products from 1nHealth, ActiGraph, Anju Software, Blue Spark Technologies, Citeline, ConcertAI, Cyntegrity, Exostar, Flatiron, Greenphire, H1, IQVIA, Medidata, Milliman IntelliScript, MMG, MyData-TRUST, Myonex, myTomorrows, N-Power Medicine, OncoLens, OneMedNet, Phesi, PicnicHealth, Precision Digital Health, ProofPilot, QuartzBio, RealTime Software Solutions, Revvity Signals, Saama, ScienceMedia, Strategikon Pharma, StudyKik, SunshineMD, Synterex, Truveta Language Model, Veeva Systems, and Yonalink.

 

1nHealth | 1nData | Booth 423

1nData is a full-service patient recruitment platform, designed by patient recruitment experts with sites and study teams in mind. The 2024 release features a site performance dashboard for sponsors and optional patient self-scheduling for sites. 1nData puts the power in the study teams’ hands by giving real-time access to recruitment dashboards. Model the time to full enrollment, drill down to solve issues at specific sites, gain insight into where drop-off occurs to keep trials on pace.

 

ActiGraph | ActiGraph LEAP | Booth 729

ActiGraph LEAP’s sensor suite passively captures continuous, raw data within a participant’s natural environment. The wearable collects over 25 digital health measures, encompassing vital signs (heart rate and variability, oxygen saturation, blood pressure, and skin temperature) alongside activity, sleep, and gait and balance measures. At the heart of ActiGraph LEAP’s innovation lies its six integrated sensors: accelerometer, multi-wave PPG, skin temperature sensor, barometer, gyroscope, and microphone. This unique combination enables traditional measures and paves the way for groundbreaking assessments of nuanced participant behaviors and conditions. This advanced wearable is designed to adapt to the complexities of modern research, allowing customization to meet specific data collection requirements for each study. The device’s sensor suite facilitates in-depth insights for more comprehensive data and offers the potential to develop novel digital endpoints. Including conventional and unconventional measures, such as capturing participant scratching in dermatitis trials or coughing frequency in COPD trials, further underscores its versatility and utility in various research settings. To optimize data quality while minimizing participant burden, ActiGraph LEAP boasts automated remote data uploads via mobile app or home data hub and an impressive battery life of 30 days, ensuring a seamless and participant-friendly experience. ActiGraph benefits from advanced algorithms developed in collaboration with CSEM, the Swiss technology innovation center, leveraging their experience in transferring new technology from research to applications in industry. The ActiGraph data science team collaborated with CSEM to develop a library of algorithms tailored to ActiGraph LEAP data, ensuring the highest precision and reliability in data analysis.

 

Anju Software | TA Scan Data as a Service for CROs | Booth 912

TA Scan is a cloud-based clinical and commercial business intelligence tool that aggregates and connects global clinical trial data, presentation data, publication data, and many other data sources from the public domain into a single intuitive database. Our data represents an accurate, comprehensive view of global R&D activity, allowing users to make more informed decisions around their study designs, feasibility, site identification, investigator/KOL identification, and streamlined diversity and site identification strategies, and management strategies. Our clinical business intelligence tool was created in 2009, in close collaboration with sponsors and CROs, to address specific pain points and challenges. In the past year, TA Scan’s offering was expanded to a tailored solution: Data as a Service. With this, TA Scan addresses the changing needs and challenges faced by CROs. Anju’s TA Scan team serves as an extension of our customer’s team, giving the CRO time to focus on strategic insights. In TA Scan’s Data as a Service offering, our team of experts provides CROs with the insights they need to drive credibility in their RFP responses with data-driven approaches. Our experts also increase the quality of the output, including enrollment projections, identification of sites with expertise with a specific subpopulation and capacity, KOL insights, and much more. Our Data as a Service solution is a perfect fit for the tight RFP turnaround timelines, provides operational support including contingency planning, and other strategic data insights needed.

 

Blue Spark Technologies, Inc. | VitalTraq | Booth 122

Blue Spark Technologies’ VitalTraq is the first-of-its-kind multi-sensor remote patient monitoring platform, that integrates one of the most groundbreaking contactless vital sign measurement sensors to date, Remote Photoplethysmography (rPPG). Using a simple 30 to 60-second selfie scan, patients, clinicians, and researchers can collect digital measurements, including Heart Rate, Heart Rate Variability, Blood Pressure, Respiratory Rate in a single contactless patient experience. VitalTraq also provides seamless support for additional sensors such as Blue Spark’s FDA cleared TempTraq continuous core body temperature monitoring patch. The VitalTraq platform consists of the VitalTraq patient application that is compatible with both Apple and Android mobile devices, VitalTraq connect HIPAA compliant cloud platform and the VitalTraq Clinician web application for real-time monitoring. The VitalTraq patient application allows for the collection of core body temperature via the Bluetooth TempTraq patch, as well rPPG vital sign measurements using the front facing selfie camera on any standard smartphone or tablet. The VitalTraq Clinician web application allows for the configuration and real-time collection and monitoring of patient/subject data. Blue Spark’s TempTraq system has been clinically proven to detect fevers significantly earlier than the standard of care and has been adopted by leading healthcare providers and pharmaceutical companies globally.

 

Citeline | Global Patient Insights V1.1 | Booth 706

Citeline’s Global Patient Insights is the next step in transforming the landscape of clinical studies. This innovative platform represents the convergence of Sitetrove’s unparalleled site and investigator data combined with datasets from US medical claims, social determinants of health, EHR data from beyond the shores of the US, global diversity insights, and census data. Harnessing cutting-edge technologies and a proprietary algorithm, Global Patient Insights meticulously cleanses, de-duplicates, and harmonizes data from a myriad of sources into a cohesive, standardized format. This process provides unmatched consistency and interoperability, allowing an overview of how data flows seamlessly across diverse systems. Even in V1, the platform brings this rich data to life through dynamic charts and visualizations crafted with usability in mind. Feasibility and site selection teams are now equipped to swiftly pinpoint optimal locations for trials, gaining insights into the geographical distribution of seasoned investigators and sites, the breadth of potential patient populations, and how these elements align with demographic and census data. This not only streamlines the site selection process but also empowers teams with the knowledge to make informed, strategic decisions. Citeline is proud to introduce Global Patient Insights, where planning meets precision.

 

ConcertAI | ConcertAI’s Digital Trial Solution (DTS) EHR-to-EDC – Version 5.1 | Booth 422

ConcertAI’s Digital Trial Solution (DTS) EHR-to-EDC is a Gen-AI and NLP powered, sponsor-designated Software-as-a-Service solution that automates data collection for specific studies and the consented patients enrolled in those studies. The solution increases the effectiveness of, and lowers the burden on, site research staff with 100% auto-population of individual study subject data into the electronic Case Report Forms (eCRFs) by using GenAI based information extraction, Natural Language Processing (NLP) and clinically validated mapping of data from a research site’s EMR. Study data for individual subjects are progressively collected in EHR-to-EDC as site research staff update the study subject’s EMR or other clinical records. Auto-population further reduces the number of laborious data queries by minimizing data transcription errors. Site study staff can review, validate and submit the information directly to the EDC system from within the EHR-to-EDC solution, increasing their efficiency and overall accuracy of trial data entry. ConcertAI’s Digital Trial Solution (DTS) solution is provider-setting agnostic and can be deployed within academic, regional healthcare, and community providers; it has been optimized for any preferred electronic medical record environment. DTS automation supports foundational research capabilities at sites with little research infrastructure and operating efficiencies at research-capable sites enabling research portfolio expansion.

Cyntegrity | MyRBQM Portal, V7.12.0 | Booth 306

Our MyRBQM Portal is a comprehensive risk management system for clinical trials, now enhanced with the “ask-AI” feature. This new addition leverages artificial intelligence to analyze various data points from a clinical trial and provide targeted risk mitigation recommendations. The system offers a unique visual representation of potential risks through a risk flower graph, making it easy to identify areas that require attention. The system connects study data, enabling the calculation of key risk indicators for regular monitoring of study and site-subject data through dashboards and reporting. The new “ask-AI” feature augments risk assessment in clinical trials, making the process more efficient and accurate.

Exostar | Exostar Clinical Trial Access Management (SAM V6.2) | Booth 712

Exostar is pleased to introduced Clinical Trial Access Management (CTAM), a real time administrative insight dashboard feature to enhance Exostar Secure Access Manager (SAM). CTAM enables Sponsor Study Managers (CRA, SSU Manager, Local Study Team Rep) to fully manage application access for their assigned study scope. CTAM introduces a standardized application access management process tailored for all your studies. By centralizing your access management portal, we bring efficiency to extreme levels, streamlining the access request process. • Automated Dashboards provide insightful metrics, offering a comprehensive view of access readiness and utilization trends. • Manage Access requests within one integrated workflow with all stakeholders. • Real-Time Intelligence – spot and resolve access bottlenecks in real-time; benchmark site performance and spot trends for process improvement. • Search and Select User Identities with SAM to dramatically shorten your user invitation cycle. Integrate LMS data to streamline training status tracking.

 

Flatiron | Flatiron Clinical Pipe | Booth 428

Flatiron Clinical Pipe, an EHR-to-EDC connector, revolutionizes study data transfer by seamlessly capturing and transferring up to 100% of EHR data into the study database. The latest release now enables the capture and transfer of three distinct types of structured and unstructured data: Routinely Captured Structured Data: Existing, discrete data fields in the EHR, including things such as labs, vitals, and medications. Trial-Specific Structured Data: Discrete data fields that Flatiron implements at the point-of-care for provider data entry during a patient visit. Examples include adverse events, tumor assessment, medical history, surgical history and concomitant medications. Unstructured Data: Data that lacks the structural organization required for off-the-shelf analysis and is instead processed by Flatiron’s abstraction team. This could include anything not able to be captured in the first two data types, such as physical exam attributes, smoking status, and cancer history. Flatiron Clinical Pipe eliminates duplicate data entry between the EHR and EDC, improving site workflows, lowering data monitoring costs, and enabling sponsors to hit study milestones faster. The impact of our technology is evidenced by successful deployment in over 85 community oncology clinics and academic medical centers, marking a 4X growth from 2022 to 2024.

 

Greenphire | GreenSpace | Booth 606

In April 2023, Greenphire launched GreenSpace, a digital platform designed to offer global trial participants a uniform experience. The GreenSpace app serves as a central hub that seamlessly connects users with trial personnel, fostering interaction, informedness, and a user-friendly experience. Moreover, the broadened payment mechanism caters to individuals with or without bank accounts, offering them the flexibility to choose their preferred payment methods – be it reloadable debit cards, virtual cards, bank transfers, or other options. In addition, trial participants need not stress about transportation to and from the trial location, as Greenphire’s tool enables Site Coordinators to quickly and easily arrange car rides for their participants and caregivers. Overall, Greenphire’s goal is to eliminate barriers that stand in the way of participating in a trial – increasing access, especially amongst underserved populations.

 

H1 | GenosAI for Trial Landscape 2.0 | Booth 923

GenosAI is developed on top of the GPT3.5/GPT4 language model, with a secure vector database in AWS cloud. GenosAI’s ChatGPT-like experience uses natural language processing (NLP) technology to translate complex data questions into comprehensive responses that expedite and scale business decisions. Users can pose complex queries and receive high-confidence, actionable responses in seconds, pulling from over 505,000 trials, 25 million publications, 10 million healthcare providers (including diversity data), 240 million patients, and 11 billion global claims. The answers provided by GenosAI Lite and Pro are solely based on H1 data. – GenosAI Lite provides text responses, only based on H1 database information. – GenosAI Pro will be able to visualize data responses and custom exports formatted as PDF files, powerpoint and excel exports. The export templates are developed and designed by the H1 team and the content included can be customized based on specific client expectations. GenosAI Enterprise will also query from client-internal datasets. For GenosAI Enterprise, the client data will be processed and stored in a secured separate vector database, away from the rest of the H1 information. Answers to user questions will then be compiled from both the H1 vector database, as well as the secured client data vector database. – GenosAI Enterprise will allow users to get query responses and actionable deliverables based on a combination of H1 data and client-provided data, such as CTMS data, feasibility questionnaires,…

 

IQVIA Technologies | Supply Automation Value Engine (SAVE) | Booth 806

By utilizing real-time data, the integration of Supply Automation Value Engine (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. For each clinical site, SAVE analyzes the number of patients in each required category, including screened and in run-in. Also, SAVE considers site and associated depots related values like depot stocks, site stocks, central pharmacy stocks, cohorts and more. All of these are settings and can be adjusted (used or not used) to determine the most relevant supply scenarios for the study in which SAVE is implemented. Following all the above capabilities, SAVE is able to identify a matching scenario in the anticipated list of scenarios configured in the model. If there is a match, then the site group strategy of the site will be updated with a new one as per configuration.

 

Medidata | Medidata Diversity Program | Booth 801

Medidata developed the Medidata Diversity Program as the industry’s most comprehensive solution that will enable greater diversity in clinical trials. The program takes a multifaceted approach that leverages data-driven site selection, pre- and post-trial patient engagement tools, insights from patient advocates, and the most patient-accessible site network trained on Medidata’s DCT technologies to support diversity before, during, and after your trial. Addressing diversity challenges within the increasingly complex clinical trial landscape is a critical step toward achieving true clinical trial success. With the Medidata Diversity Program, biopharmaceutical companies can integrate a comprehensive range of industry-leading solutions to create an innovative, patient-centric approach that meets the needs of their specific diversity and clinical trial needs.

 

Milliman IntelliScript | Irix Prescription Data, Irix Medical Data, and Irix Rules Engine | Booth 103

Pre-screen clinical trial participants at a glance. The Irix Rules Engine instantly interprets Prescription Data and Medical Data to drastically improve the time-intensive and costly recruitment process. With basic patient information and a HIPAA consent authorization, the Irix Rules Engine clinically interprets and returns up to seven years of structured prescription histories and medical claims for nearly any individual. Now there’s no need to sift through error-prone participant questionnaires and interview notes for trial recruitment. Instead, the custom-programmed, fully automated Irix Rules Engine spots each trial’s inclusion and exclusion criteria in a wealth of data—so recruiters and sponsors can find the most qualified participants among a sea of candidates in just seconds. · Personally identifiable prescription histories and medical claims data delivered instantly – Via intuitive, simple-to-use web-based user interface, or Via client API · Irix Rules Engine automatically highlights trial eligibility · Easy to install (requires little to no IT lift) This secure and fully operationalized technology revolutionized life and health insurance underwriting over two decades ago and is in use with nearly all major carriers. Now, with innovative adjustments and upgrades, it’s being introduced and is poised to disrupt clinical trials recruitment. Nothing else like it is available in the clinical trials industry.

 

MMG | ‘Me.’ for Achieving Diverse Representation in Clinical Trials | Booth 821

‘Me.’ is a method powered by over 20 years of community-focused outreach to deliver clinical trial recruitment that overcomes the most critical enrollment barriers and achieves appropriate representation. For MMG, diversity and representation is not a statistical goal, it is how we have understood patient recruitment for decades. Service offerings by ‘Me.’ range include patient-centric tools & services, community engagement teams, and site engagement resources.

 

MyData-TRUST | MyData-TRUST | Booth 631

MyData-TRUST supported more than 600 key players in the global life sciences sector, involved in research and development of innovative therapies. We provide data protection compliance for all matured data protection legislations around the world. We provide a one-stop-solution to handle multiple challenges of our customers, who are running the trails in different cities or continents. Each service is applicable to the following regulations: EU GDPR, UK GDPR, Swiss FADP, US regultions, Australian APP, Canadian PIPEDA, Thai PDPA, Turkish KVKK and Brazilian LGPD. MyData-TRUST offers tailored solutions, including: • Training: Whether on-site or through our e-learning platform (with the option of LMS integration), we equip organizations with the knowledge needed for compliance. • Data Protection Officer as a Service: From one-off support to comprehensive DPO role management, we adapt to organization’s specific requirements. • DPR (Data Protection Representative): Leveraging our strategic presence in key countries (EU, CH, UK, TH, TR), we ensure compliance with local regulations. • Audit & Risk Analysis and Inspection Readiness: Our services help organizations navigating audits seamlessly, ensuring readiness for inspections. • Legal Data Protection Support: Our team of experts provides legal guidance tailored to the intricacies of data protection laws. • Cybersecurity and IT Support: We offer comprehensive support to fortify your organization’s cybersecurity infrastructure. MyData-TRUST stands as a beacon of support, allowing life sciences organizations to focus on pioneering advancements in life sciences while we expertly handle the intricacies of data protection as your trusted one-stop shop services provider.

 

Myonex | CTRx | Booth 1221

Myonex specifically has developed a global GxP compliant portal. For the United States, clinical sites are able to download activated CTRx pharmacy cards for patients. The CTRx Pharmacy Cards only cover medications required in the study. The Clinical Operations teams at the Sponsor can see all of the CTRx Network claim data without PII but with subject numbers so they can understand costs being accrued and see real time dispensing data. Globally, the portal can also enable clinical trial sites to be able to request products from depots and pharmacies.

 

myTomorrows | TrialSearch AI by myTomorrows | Booth 1220

myTomorrows’ TrialSearch AI is a physician-focused, pre-screening clinical trial search tool. By leveraging AI technology, it allows physicians to identify potentially eligible clinical trials or expanded access programs (EAPs) for their patients, within minutes. TrialSearch AI helps physicians by providing quicker insights into available pre-approval options. By cross-referencing a patient’s medical summary with multiple clinical trial eligibility criteria sourced from public registries, the tool presents the physician with a list of potentially available clinical trials, and where appropriate, EAPs. It will then prompt the physician to do manual checks and ask them to confirm whether a pre-approval option is suitable for the patient. In doing so, the tool saves precious time for physicians and keeps critical clinical trials from getting lost in the depths of non standardized databases. The physician can still make an informed decision based on the transparent and personalized results provided to them by TrialSearch AI, and is then able to use the myTomorrows end-to-end platform to directly make patient referrals to relevant trials and EAPs. In doing so, TrialSearch AI aims to transform the search for clinical trials for patients with unmet medical needs; all whilst keeping physicians firmly at the centre of the process. “Our team of researchers and developers designed TrialSearch AI to bring greater speed, transparency, and accuracy to the complex, time-consuming task of manually searching for clinical trials,” said Michel van Harten, MD, CEO at myTomorrows.

N-Power Medicine | N-Power Point-of-Care Platform | Booth 1137

N-Power Medicine is building a network of oncology practices whose data infrastructure and workflow are optimized for clinical trial participation and data insights generation for therapeutic development. The novel platform, which includes a patient Registry (Kaleido), technology, staff and AI, is applied across all patients in the routine care setting, which unlocks bandwidth for site staff and equips investigators and research coordinators with the data needed to identify eligible patients at the right moment. Biopharma partners, in turn, can harness the network to enroll patients into studies faster, answer research questions, and equip themselves with the data required for robust decision-making. Offering for oncology practices that partner with N-Power: -Experienced staff who draft the medical note, introducing standardization and freeing up time for physicians and staff for patient care and clinical research -A protocol defining what data to collect when and the provision of staff who abstract and track down missing data -Insights from the NPM data platform for practice management and clinical research Offering for biopharma companies: -A network of clinical trial sites, supported by a data platform and infrastructure, participating more efficiently in clinical trials through streamlined trial qualification and startup, accurate and rapid identification of patients and staffing support for clinical trial implementation to ensure high-quality data -Comprehensive insights on trial eligibility and enrollment that support protocol amendments and future protocol design -Cohorts of patients within the Registry, with the option to collect novel data, to answer research questions and provide external benchmarking data for development decision-making.

 

OncoLens | Clinical Trials PatientID Version 1 | Booth 935

OncoLens is an oncology-focused treatment planning platform used regularly by more than 200 Cancer Centers in the U.S. This broad network, combined with AI/NLP technology which identifies appropriate patients creates a premier patient identification and enrollment tool. Once an eligible patient is identified, the provider team is alerted within the planning platform—a unique feature!

 

OneMedNet | OMNI 24-01 | Booth 228

OMNI is Proprietary Technology that organizes patient data making it searchable by any criteria and prepares patient data for its secondary use. OMNI 24-01 enhanced its feature set by identifying and removing PHI from images of all modalities including dual-energy x-ray absorptiometry(DEXA), which contain larger amounts of PHI than most other DICOM modalities due to these studies presenting multiple combinations of pictures of anatomy and rasterized text. Note, the burnt-in PHI is typically found in both the pictures and the charts which are fully digitized and integrated into each study. OMNI identifies and removes this PHI with high accuracy and high speed.

 

Phesi | Trial Accelerator Patient Access Score V1 | Booth 1021

Phesi, a global provider of patient-centric data analytics, has enhanced its AI-driven Trial Accelerator platform with the addition of a new Patient Access Score, enabling clinical trial sponsors to identify the most effective investigator sites, improve enrollment and reduce cycle times. Trial Accelerator puts the patient at the heart of clinical development. Leveraging global data from more than 100 million patients and 500,000 clinical studies, a detailed picture of the patient can be built. This is called a Digital Patient Profile. From this, Phesi’s Patient Access Score is derived – a unique performance measure for selecting the best performing investigator sites and for eliminating non-enrolling sites and unnecessary protocol amendments. Trial Accelerator and its Patient Access Score delivers precision, insight and certainty to clinical trial planning and execution. It offers detailed insights into an investigator’s potential patient outreach, their historical experience with clinical trials, and their likelihood to access the patient population defined in the protocol. It does so by focusing on investigators from Trial Accelerator who contributed patients to the specific Digital Patient Profile used in construction. The greater the number of patient cohorts associated with a specific investigator in a Digital Patient Profile, the more likely the investigator site can recruit patients in accordance with the protocol design. Patient Access Score is applicable across all indications. It is particularly valuable for rare diseases where patient numbers are limited and for non-rare conditions with complexities such as comorbidities or that have a wide range of patient characteristics.

 

PicnicHealth | PicnicHealth Study Portal | Booth 1132

PicnicHealth’s new Study Portal is a tailored dashboard that provides real-time insights on study status and progression. Using a simple and clear interface, life science companies can see all data for their virtual study, including adverse events, protocol deviations, patient screen fails, patient diversity, and more. The portal also leverages artificial intelligence and machine learning to read through patient records to find indications that patients meet eligibility criteria and have adhered to study tasks, ensuring patients are appropriately qualified into a study and verifying that patients are completing necessary telehealth visits and surveys.

 

Precision Digital Health | SUMMA1.1 | Booth 1036

SUMMA Mobile is our new APP developed to (1) extract CGM/BGM sensor data securely and easily in near-real-time using Bluetooth and, (2) address compliance and safety, and (3) improve data quality and Participant experience by incorporating Intelligent Automation Technology to enable dynamic workflows and event-driven tasks based on study participant data and protocol design. To address compliance and safety SUMMA provides dynamic workflows and event driven tasks driven by study participant data and protocol design. For example, in study designs utilizing CGM and/or self-monitoring of blood glucose (SMBG) clinical endpoints, hyper/hypoglycemic safety surveillance checks can automatically be generated and send alerts or instructions directly to the study participant. Downstream, the associated data from these real-time alerts and events are available to study teams for medical review and their impact on targeted clinical endpoints.

 

ProofPilot | Site CoPilot | Booth 1223

Site CoPilot is a responsive web application, accessible by any internet enabled device. The suite of products is rounded out by SiteExplore and Site Comms. SiteExplore empowers site staff with quick access to a comprehensive digital repository of study-related content, including protocols, manuals, training content and visit overviews. With SiteExplore manually thumbing through disparate documents is a thing of the past. SiteComms enables research staff to initiate real-time chat to Medical Monitors, CRA’s and relevant study team members for urgent medical queries. SiteComms maintains compliance and expedites decision making of mission critical challenges by circumventing crowded email channels. All products are GXP, HIPAA and GDPR compliant and can connect with any 3rd party technologies.

 

QuartzBio, part of Precision for Medicine | QuartzBio virtual Sample Inventory Management (QuartzBio vSIM) v9.0.4 | Booth 300

virtual Sample Inventory Management (vSIM) | Sample Intelligence for the Entire Precision Medicine Lifecycle is a SaaS product, powered by QuartzBio’s Biomarker Intelligence Platform, engineered by subject matter experts. Digitally monitor the status of samples on trial or create a virtual biorepository to have a 360° look around your entire biospecimen landscape. At the click of a mouse, gain intelligence into sample location, status, consent, discrepancies, vendor performance metrics, and availability of samples for testing. Get these answers and more in minutes, across sites, labs, and repositories. Intelligence Made Accessible through Human-centric Design: vSIM, with this release featuring a reimagined user interface, enables cross-functional teams in biospecimen/ biomarker/ clinical operations, translational research, and executive leadership to gain insights rapidly without requiring data expertise. Combining Data Management and Business Intelligence: Built on QuartzBio’s Biomarker Intelligence Platform, vSIM is a fully compliant (FAIR principles, 21 CFR Part 11, GxP, GDPR, HRGRAC) product, consisting of data management and business intelligence tooling. These tools enable quality data as the foundation for insight generation and seamless information consumption through purpose-built analytics and reporting. With this leading-edge product, teams can: Track samples across their lifecycle with dynamic reports comparing actual and expected sample status Proactively monitor sample stability and consent expiration with automated notifications (NEW in v9) Quickly and accurately identify samples to ship for testing using intuitive Sample Ship List generator (NEW in v9) Report portfolio-level metrics and vendor and site performance across programs, including closed and active studies, to inform planning (NEW in v9)

 

RealTime Software Solutions | ENGAGE! | Booth 407

As part of the February 2024 release for RealTime Software Solutions, ENGAGE! is now available in all territories. RealTime’s ‘ENGAGE!’ product suite includes MyStudyManager, the first site-based participant portal that can be used across all clinical research studies to engage with participants in remote settings. ENGAGE! supports decentralized trials and increases the diversity of trial participants. Additionally, for an enhanced experience, the portal integrates eCONSENT, to allow for remote consenting. Technical Specifications

• Unlimited participant linking to the MyStudyManagerTM Portal • eCONSENT review and signing • Visit schedules • Virtual visits • Study tasks and notifications Site contact information Stipend balances • eSOURCE forms (ePRO/eCOA) • Document management • Visit satisfaction surveying and reporting • Part 11 and HIPAA/GDPR compliant • Mobile App or desktop browser portal

 

Revvity Signals | Signals Clinical 2.0 | Booth 236

Signals Clinical is a SaaS clinical data science platform designed with the explicit purpose of ‘enabling faster decision making’ by streamlining clinical workflows and increasing efficiencies across the lifecycle of clinical data management and analysis. These objectives are achieved by centralizing data management of clinical trial data, standardizing the data using custom data models, and making the data readily accessible for real-time advanced analytics (powered by Spotfire) to address clinical use cases such as safety and efficacy analysis and trial progress. Furthermore, Signals Clinical’s modern and scalable architecture allows for rapid searching across large datasets to facilitate cohort creation for cross-study analysis to further aid evidence-based data discovery. Designed with end-users in mind, the user-friendly applications and self-service access to clinical data aims to remove the inefficiencies from the process of data access and analytics. The newest release of Signals Clinical v 2.0 further expands on the foundational capabilities of the platform to enable clinical study teams to leverage ‘integrated collaboration’ during their clinical data review process to review, query and track the status of their line listings and seamlessly collaborate with other stakeholders via real-time data sharing and commenting on specific data points. This new capability ensures that all stakeholders are on the same page and working towards the same goals, thereby, further enhancing overall team efficiency and enabling faster decision making.

 

Saama | Saama platform | Booth 132

Saama announced groundbreaking features within its AI-driven platform: ● Interactive Review Listings (IRL): Data managers, medical monitors, and vendors can now work together in a single environment to complete comprehensive data reviews. Study teams can access and review the data they need without waiting for programmers. Users can create custom listings using GenAI and track all queries in a single location. Users can also collaborate with teams by assigning tasks, raising and inspecting queries, and managing vendors all in one place. ● Data Quality (DQ) Co-Pilot: Is a first-of-its-kind GenAI feature embedded within Smart Data Quality (SDQ) that eliminates the need to manually program, test, and deploy data quality checks. Data managers can describe their desired DQ check, and DQ Co-Pilot will generate accurate code and test data in seconds. ● Chat for Patient Insights: This GenAI innovation allows medical monitors to ask questions of their data in natural languages and receive the data they need in seconds. Medical monitors can quickly create custom listings without programmers or coding knowledge, saving weeks on data analysis. ● Data Hub: Users can now apply different data standards by study, manage blinded datasets, as well as leverage Saama’s AI-driven data mapping feature for faster data standardization. ● Operational Insights: An all-new interface allows executives and portfolio managers to quickly drill-down from high-level dashboards to study-level data on a single screen. The intuitive interface allows users to easily identify KPIs of interest and brings together data from multiple source systems in a single view.

 

ScienceMedia | SMi Trial 4.0 | Booth 1207

Experience a transformative shift in clinical trial protocol training and compliance with SMi Trial. SMi Trial is a user-friendly, integrable cloud-based mobile platform with customized content. We power biopharmaceutical and medical device companies and Contract Research Organizations (CROs) to embrace the science of learning to: alleviate screening failures; reduce participant drop-outs, especially diverse and/or naïve volunteers; and minimize risk to data quality, notably in decentralized trials. Now in its 4th iteration, SMi Trial released new updates in February 2024 that improved usage function around site engagement and compliance. Upgrades include improved analytics and mobile user experience via new automated training completion functionality and the addition of aggregate reporting. Additionally the architecture of SMi Trial’s platform has been strengthened to refresh certain elements of each page for faster loading times and a more seamless user experience. Due to customer feedback, we have expanded our product line to include patient educational materials tailored for diverse populations to further improve patient retention. This release marks a full change to 4.0, requiring substantial validation and testing as well as documentation to withstand client vendor audits.

 

Strategikon Pharma | Clinical Maestro 4.1 | Booth 200

The Clinical Maestro SaaS solution is uniquely designed to empower professionals engaged in outsourcing, budget development, contracting, vendor category and performance management. Clinical Maestro addresses longstanding challenges by modernizing clinical business operation transactions. Features within the Clinical Maestro 4.1 release, include: • Automated generation of contracting documents, like Statements of Work, eliminating cut-and-paste processes and errors. Configurable templates leverage proposal data to create customized documents efficiently. • VISION – the first solution to support vendor quality management, performance, oversight, and risk minimization. Uniting disparate data sources into a single source of truth to strengthen oversight, enhance efficiency, and facilitate informed vendor management, VISION offers complete visibility into studies, departments, functions, and contracts. Streamlining manual tasks like trackers and surveys, VISION reduces data entry efforts by over 90% and its alert functionality reduces risk by 95%, notifying stakeholders of contract expiration, low performance, and re-qualification requirements. Dashboards provide access to vendor portfolio metrics for reporting and data-driven decisions. • AI-enabled Bid Grid Mapping technology delivers over 90% reduction in effort and eliminates over 99% of mapping errors, for significant cost savings for both Sponsors and Service Providers. • Fixed-rate budgeting and sourcing capability. Once agreed by both parties, it activates fixed cost/effort templates that are enforced during future bids with the Provider. • Enhanced milestone payment functionality, enabling Sponsors to negotiate and track cash flow during outsourcing activities and associate which cost accounts are affected by the payment. • Expanded benchmarking capabilities, including data for ePRO/eCOA, IRT, IRB-IBC Management, and other additional services while maintaining exceptional accuracy.

 

StudyKik | CarePackage | Booth 1007

Launched in late 2023, CarePackage emerges as a global end-to-end platform crafted to navigate the intricacies of the clinical trial lifecycle, blending empathetic technology with human-centered design. Distinguished by its unwavering commitment to enhancing the human experience, CarePackage stands our as a platform that renders the journey more accessible, transparent, and user-friendly for patients, research sites, and sponsors alike. CarePackage goes beyond functionality; it is a comprehensive solution that elevates and supports every facet of the clinical trial journey. Featuring new technologies that facilitate swift and diverse patient enrollment, streamlined consent processes, and engaging custom study applications featuring eCOA/ePRO for successful participant retention and data collection. Additionally, it incorporates a global patient reimbursement system and seamlessly integrates in-depth trial analytics – all within a unified platform for a truly connected journey. Adhering to the highest standards of compliance, CarePackage meets stringent requirements of multiple frameworks and certifications, including GDPR and HIPAA. In doing so, CarePackage goes beyond being just a solution; it is a holistic, user-centric, and compliant transformation that redefines the clinical trial technology landscape, setting new standards for excellence, accessibility, and transparency.

 

SunshineMD | Investigator Performance Tool, v2.0 | Booth 636

The Sunshine Investigator Tool draws upon data from Open Payments, ClinicalTrials.gov and SunshineMD proprietary classification and modeling systems to construct a user accessible database of virtually every active US clinical investigator since the end of 2013. For these 75,903 investigators in Open Payments, the SunshineMD database contains critical information, including: – Almost every study each investigator has worked on. – Each investigator’s enrollment performance compared to every other US investigator on a given clinical trial. – Investigator specific summary enrollment and start-up performance scores across all the studies on which that investigator has worked compared to any subset of investigators in the US investigator population, e.g., by specialty. – Investigator contact information. For virtually every pharmaceutical industry study the following information is also available in the SunshineMD Investigator Tool: – The names and contact information of every US investigator who worked on that specific study – How well each of the investigators working on that study enrolled compared to all the other investigators on that specific study. – Study design details and key dates.

 

Synterex, Inc. | AgileWriter 1.0 | Booth 329

A key innovation from Synterex, AgileWriter is a first-in-class AI tool for composing patient-facing documents. AgileWriter can trim up to 50% of time from the standard manual process of producing and managing documents, recapturing lost time and expense and aiding in getting therapies to patients sooner by simplifying complex processes and streamlining document generation. AgileWriter starts by efficiently ingesting clinical trial source documents in various formats. This capability allows for the seamless integration of diverse materials, setting the stage for accurate and comprehensive document generation. The tool uses advanced AI models to identify and extract pertinent information from ingested documents. This process ensures that essential data components are accurately retrieved for use in creating new documents, reducing the chances of human error and enhancing the reliability of the final documents. AgileWriter cross-verifies the extracted data using a biochemistry-oriented knowledge base, adding depth and context. The data is then translated into coherent, easily understandable text using LLM. This step is vital in converting technical data into a format accessible to a broader audience, including patients and non-specialist stakeholders. The final phase involves using the processed information to produce the destination documents, such as informed consent forms (ICFs), which adhere to regulatory and ethical standards. This process not only ensures compliance but also significantly reduces the time required for document preparation. The implementation of AI tools in clinical document generation by Synterex is a testament to the company’s commitment to innovation in the face of economic and healthcare challenges. By reducing the time it takes for a drug to reach the market, these tools not only minimize potential revenue losses for pharmaceutical companies but also accelerate the delivery of critical healthcare solutions to patients in need.

 

Truveta | Truveta Language Model (TLM) | Booth 333

TLM is a large-language, multi-modal AI model for transforming EHR data into billions of clean and accurate data points for research on patient outcomes for any drug, disease, or device. TLM is trained on data from Truveta’s health system members, currently representing more than 100 million patient journeys, including 8.4 billion diagnoses, 4.1 billion encounters, and 4 billion medication orders. Using this data, Truveta’s clinical expert annotation team labels thousands of raw clinical terms, including misspellings and abbreviations, to train and evaluate TLM with a focus on clinical accuracy. This annotation process is complex and nuanced, with all terms being assessed by multiple experts. In the event of disagreement, those experts discuss and reach alignment. Clinical experts label concepts, build consensus, and review low-confidence TLM results using a custom tool designed to improve clinical accuracy of Truveta Data over time continuously. After running TLM, each concept receives a statistical confidence score. Low-confidence results are reviewed to create additional training data for the model. TLM is currently achieving high accuracy on diagnoses, medications, lab results, lab values, clinical observations, and more. TLM’s accuracy improves over time with ongoing training but already today outperforms state-of-the-art approaches, including GPT-4, LogMap, AML, BERTMap, and the latest ontology matching frameworks from the Ontology Alignment Evaluation Initiative.

 

Veeva Systems | Veeva Launch Pad | Booth 713

Veeva Launch Pad offers a simple way for sites to organize and access sponsor technology at no cost to sites or sponsors. The application makes it easy for clinical researchers to create and share study profiles containing links to all the relevant sponsor technology systems and help desk contacts used for a clinical trial. Launch Pad works with all sponsor technology systems. For sponsors that use Veeva clinical applications during a trial, VeevaID provides single sign-on capabilities through Veeva Launch Pad. When a sponsor uses Veeva technology and enables VeevaID, investigator sites can access applications, like Vault EDC and Veeva RTSM, with one click. No additional username or password is required. Veeva Launch Pad is brand new, launched in November 2023.

 

Yonalink | Yonalink CONNECT V 5 | Booth 733

Yonalink CONNECT is an innovative solution that fosters interoperability by using AI-driven data mapping to establish a seamless flow of data between electronic health records and EDCs (or other data repositories). This cloud-based offering facilitates a more comprehensive and standardized approach to data collection, management, and transfer, and can be implemented in clinical trials of all phases, sizes, and therapeutic areas, without the need for time-consuming on-premises integration. Yonalink CONNECT can gather data from any EHR or DHT across the globe and automatically convert the data into the appropriate format and placement in the EDC. Yonalink CONNECT also provides unrivaled scalability as the system learns the desired data transfer and conversion patterns and implements them into future data requests. This allows for the addition of infinite data points without increasing staff burden, transfer time, human errors, or SDV time.