October 24, 2024 | The results are in: there are nine new product finalists in the 2024 SCOPE Europe Best of Show awards that will be on display next week in Barcelona. Starting at the opening reception, the SCOPE Europe 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 Europe exhibitors, and exhibiting companies entered their products for consideration in advance of the event. Twelve 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 Best of Show Award once the conference has begun. Please note, selection is not based on level of sponsorship or exhibit participation. Products must have been newly released or improved since October 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 Tuesday, October 29 at 10:53am and close at 11am on Wednesday, October 30. 

Winners will be announced live at the event on the exhibit hall floor on Wednesday, October 30, at 12:30pm and during the Wednesday afternoon plenary session.  

The new products are listed below in alphabetical order by company name. The product descriptions below were submitted by the entering companies.  

2024 Finalists include Anju Software (TA Scan v1.7.8.3), Care Access (Future of Medicine), Citeline (Citeline SmartSolutions), CluePoints (Site Profile & Oversight Tool-SPOT), Cyntegrity (MyRBQM Portal, V8), Exostar (Clinical Trial Access Manager), Greenphire (Patient Support -Travel + Logistics // Concierge), Inetsys S.L (ShareCRF RBM), Medidata, Dassault Systèmes. (Clinical Data Studio), myTomorrows (myTomorrows Platform, Version 1.3), and Validated Cloud (Life Science Community Cloud for Regulated Systems).   

Here are the full entries:  

Anju Software  
TA Scan v1.7.8.3 | Booth 40 
https://www.anjusoftware.com/ta-scan-data-science/ 

Brief Description of Problem Addressed by Product:  
Poor recruitment to clinical trials is a long-standing and global problem. Nearly 80% of clinical trials fail to meet their enrollment timelines, 11% of selected sites never enroll a single patient, and 48% of all sites under perform, meaning that they do not deliver the number of patients they expect. Additionally, sponsors’ original timelines for Phase 2 – 3 studies usually end up doubling to meet the required enrollment target.  To drive predictability in enrollment and study timelines, sponsors rely on their study feasibility teams. Faulty enrollment forecasts, however, cause sponsors to embark on trials with a false sense of what they can accomplish in a certain time frame. Any deviation from the forecast and delays in study timelines has a significant negative effect on study costs.  Teams need to understand the competitive landscape for the target patient subpopulation, identify the optimal mix of countries, sites and investigators for a specific study, and set realistic timeline scan help match reality with expectation to avoid unnecessary delays and amendments throughout the clinical trial. To minimize the risk during strategic planning and clinical trial execution, and maximize the accuracy of enrollment forecasts, a team’s expertise and experience with past clinical trials is crucial, and historical public data provides critical insights on trial benchmarks and the continuously evolving competitive landscape. The dispersed nature of data and the need to combine internal and external insights, adds significant complexity to the process and hinders the generation of meaningful and especially accurate insights. 

Brief Product Description & Technical Specifications: 
TA Scan is a cloud-based clinical and commercial business intelligence tool that aggregates and connects a broad range of global clinically relevant data sources. Clinical trials, presentations, publications, and many other data sources from the public domain are semantically linked into a single intuitive database. Our high-quality data and built-in advanced analytics provide 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 management strategies.  In the past year, TA Scan expanded its core feature for clinical operations teams. TA Scan’s new Trial Feasibility Flex simplifies the highly complex process of clinical trial feasibility, thereby adding strategic and operational value. While keeping TA Scan’s high-quality data and powerful functionalities, the Trial Feasibility Flex allows more customizable manual inputs, enabling highly precise enrollment projections tailored to the users’ trial design. Through the simulation, users can assess the impact of a wide range of variables – such as country selection, preferred site lists, country-level patient distribution, regulatory delay, anticipated recruitment rate, and other trial parameters – on clinical outcomes. On top of predictive enrollment scenarios, country-level trial timings, and competitive insights, Trial Feasibility Flex provides feedback on sponsors’ preferred site list, by assessing specific trial criteria and sites’ capacity in the current competitive landscape. Moreover, it provides alternative sites with capacity to recruit. The insights generated help match reality with expectation and generate the actionable insights needed to optimize country and site selection, supporting confident and efficient trial planning. 

Brief Description of Innovative Technology: 
TA Scan technology collects and aggregates disparate and unstandardized sources at scale. Our patented TrialCloud technology allows us to semantically link all data types, which supports the extraction of hidden insights. The built-in Trial Feasibility Flex (TFF) module uses a tailored Monte Carlo simulation. Using these algorithms, the simulation strives towards an output that is as stable as possible with the lowest possible variability in terms of enrollment curves. The simulation tool adheres to the manual input parameters defined by the user to generate precise enrollment projections tailored to the user’s trial design and strategy. Anju and TA Scan maintain their commitment to provide continuous improvement and innovation to ensure global insights can be extracted to make clinical trial planning and execution more efficient. 

Care Access  
Future of Medicine | Booth 17 
https://careaccess.com/research-sponsors/community-health-screening 

Brief Description of Problem Addressed by Product:  
The limited capacity of the traditional clinical research model has not kept up with the rapid pace of discoveries from medical science, thereby leaving too many potential cures and treatments untested and unusable for people who might need them. As a result, people who could benefit from these potentially life-saving therapeutics are left waiting. Challenges in study enrollment are the most commonly cited reason for this bottleneck in clinical research. 

Brief Product Description & Technical Specifications: 
Future of Medicine by Care Access is a grassroots community health screening program that significantly accelerates enrollment of research studies while providing valuable health insights, education, and services to individuals and whole communities. Our study-agnostic health screenings (pre-screenings) create a participant community that is more aware of their health status and educated about the importance of clinical research and its potential impact for future generations. In the last year, over 100,000 people have been screened in the program—individuals who have shared their medical history, completed a blood draw, given informed consent, and expressed interest in participating in research. Future of Medicine health screenings include biomarker testing for risk factors where high-priority research is happening, such as cardiometabolic diseases, Alzheimer’s, infectious diseases, and more. By screening participants for specific eligibility criteria, the program significantly reduces screen failures. Our pre-screenings can start many months before a study is activated, allowing sites to begin randomizing participants on day one of the study versus months later through more traditional practices. By decoupling screening and enrollment, Future of Medicine enables ongoing recruitment across entire portfolios, independent of individual study timelines. 

Brief Description of Innovative Technology: 
The key innovation of Future of Medicine is making pre-screenings accessible to everyone, including previously unreached populations. This is rooted in our novel blend of operations, logistics, and mobile research infrastructure. Future of Medicine brings health screenings to nearly any type of community setting, including clinics, houses of worship, senior living communities, recreation centers, local businesses, college campuses, and fairs. Health screenings are made available in urban, suburban, rural, and even remote locations with very limited infrastructure—all while adhering to rigid protocols with a robust quality assurance system that ensures quality participant care, clear operational compliance and sound research data. This flexibility is made possible by an innovative trial delivery model that centrally orchestrates research sites, mobile clinics, pop-up clinics, in-clinic staff, remote staff, traveling staff, and distribution hubs. Clinical workflows and data management are streamlined with purpose-built software called Care Console. The application is designed to simplify workflows, assure data integrity, and facilitate high-quality referrals. The program integrates Care Access’s operational innovations, robust infrastructure, regulatory expertise, and grassroots community partnerships to make participating in research an opportunity for every community. 

Citeline
Citeline SmartSolutions | Booth 14
https://www.citeline.com/en/smartsolutions

Brief Description of Problem Addressed by Product:

Protocol amendments are a significant financial burden, often caused by avoidable issues such as overly restrictive language, failure to consider the patient population — including diverse groups— insufficient input from operational teams, and errors made during protocol iterations. Medical teams need access to high-quality data from past trials to design protocols that minimize these operational errors and limit amendments. On the operational side, teams must thoroughly review protocols to assess the feasibility of conducting the study, taking into account factors such as patient population, site capabilities, and logistical requirements. Selecting the right investigators who are best suited to your protocol is another critical challenge. Investigators need to have the appropriate expertise, access to the relevant patient population, and a track record of success to ensure the study can be executed smoothly. Misalignment in this area can lead to recruitment delays and protocol amendments, further increasing costs. As protocols grow increasingly complex, the number of amendments rises, leading to costly delays. Each day of delay can result in approximately $500,000 in unrealized or lost prescription drug sales and $40,000 in direct clinical trial costs, making it imperative to develop better protocols that reduce the risk of amendments.

Brief Product Description & Technical Specifications:

Clinical study teams can optimize clinical trial planning and site selection with Citeline’s AI-enabled SmartSolutions. From primary endpoints to inclusion/exclusion criteria and selecting protocol-matched investigators, Citeline SmartSolutions provide medical, clinical operations, and feasibility teams with a competitive advantage by reducing protocol amendments, meeting enrollment goals, and delivering trials on time. Protocol SmartDesign uses advanced machine learning and large language models, powered by Citeline’s Trialtrove and Sitetrove solutions. By combining industry-leading data with real-world performance insights, Protocol SmartDesign enables life sciences teams to build more predictable trials and accelerate development timelines. Researchers can rely on trial, site, investigator, diversity, and real-world data (RWD) to make informed decisions. They receive recommendations on primary endpoints and inclusion/exclusion criteria, can forecast enrollment rates, and predict trial duration using historical and performance data. They can seamlessly review the source material informing the recommendation in the same application. This approach significantly reduces the likelihood of costly protocol amendments, while a centralized platform streamlines communication, enabling teams to refine and finalize protocols efficiently. Investigator SmartSelect revolutionizes country and investigator selection, drawing on 20 years of experience as the leading source of business intelligence for clinical trial investigator selection. It allows researchers to generate a pool of protocol-specific investigators in minutes, identify the best countries, site allocations, and investigators using a proprietary algorithm, and optimize feasibility and decision-making through a seamless, unified experience within Citeline’s integrated suite. These capabilities ensure trials are delivered on time and with greater precision, helping to optimize clinical development from planning through execution.

Brief Description of Innovative Technology:

Protocol SmartDesign has been developed using a collection of AI techniques, selecting the best model for the job at hand. It starts with Citeline’s vast database of historic trial information in structured and unstructured forms. The data are categorized using logistic regression for primary endpoints and the deep learning model, BioBERT, for the inclusion and exclusion (I/E) criteria. Recommendations for endpoints and I/E are generated using the Claude 3/3.5 Sonnet large language model. Predictive enrollment rates and length of study are delivered via the machine learning models, CatBoost and Random Forest. Investigator SmartSelect finds its investigator recommendations through a complex proprietary algorithm that factors in more than two dozen investigator and study properties found in Citeline’s database of over 550K investigators as well as real-world claims and electronic health records and epidemiology and payment data. Each property was analyzed with machine learning to understand the effect on investigator performance and interaction with other properties. When a customer requests recommendations, each investigator is scored by the algorithm and ranked based on the target study criteria.

CluePoints 
Site Profile & Oversight Tool (SPOT) | Booth 25 
https://cluepoints.com/what-we-do/site-profile-oversight-tool-spot/ 

Brief Description of Problem Addressed by Product:  
Site Monitoring in clinical trials can be challenging. A lack of supporting tools leads to time consuming site performance evaluation and inefficient monitoring and visit planning. Current solutions can be rigid around source data verification and review whilst limiting the ability to document decisions that have been made. Due to a lack of visualization tools to and data driven insights it is difficult to adapt and implement subjective monitoring approaches. 

Brief Product Description & Technical Specifications: 
SPOT enables adaptive site monitoring so teams can swiftly pinpoint anomalies and translate insights into actionable strategies. With SPOT, sponsors and CROs can improve their ability to evaluate the performance of clinical trial sites and adjust site visitation plans more effectively and efficiently. These adjustments more accurately consider risk and resource workload. SPOT has been created to support Site Managers by delivering: - Data-Driven Site Scoring that incorporates central data review risk, onsite workload, and other relevant factors - User-Triggered Actions based on identified insights, enabling timely responses - Automated Actions to swiftly identify actionable insights without user intervention - Risk Mitigation to avoid potentially costly issues - Data Visualization to inform decisions and quickly take action - Data Integration to centralize diverse data types and enhance site management Visibility into the actions and reviews of site managers and CRAs Role-based security measures so that users have access to data at the right time  

Brief Description of Innovative Technology: 
SPOT uses an algorithm based on parameters to predict workload and suggest monitoring visit dates. Parameters used include new enrolled patients, number of pages to be SDV, SDR, number of queries. The number of hours associated with an activity is determined by the sponsor and is fully customizable. The Risk at site level is determined with information from CMP such as KRIs and DQA. SPOT dashboards allow the central monitoring team or local team to see their sites and confirm when monitoring visits should occur. From SPOT, the CRA can trigger actions that via an API allows the CTMS to retrieve monitoring visits created from SPOT. Actions are created in CTMS and updated in SPOT through the API. Based on SPOT dashboards with information from different systems (i.e. CTMS), the study team can adapt the SDV/SDR strategy based on the risk they see from data trends as well as modify/put on hold the recruitment of a given site. 

Cyntegrity 
MyRBQM Portal, V8 | Booth 19 
https://cyntegrity.com/rbqm-software/ 

Brief Description of Problem Addressed by Product:  
Clinical trials often struggle with time-consuming and error-prone processes for identifying risks within protocols, leading to gaps that can affect patient safety and data quality. The AI-Augmented Protocol Analysis tool addresses these challenges by automating the review of uploaded protocols, allowing early identification of risks, and suggesting appropriate actions to manage them. It supports Quality by Design (QbD) principles by systematically assessing protocol components, aligning them with known risk categories and generating risk statements linked to key indicators. This structured approach ensures that risk assessment is thorough, reducing reliance on manual checks and enhancing trial consistency. The tool's ability to assign risk ratings and propose mitigation strategies simplifies the process, enabling quicker and more reliable decisions while maintaining high-quality standards throughout the trial lifecycle. 

Brief Product Description & Technical Specifications: 
The latest MyRBQM Portal release features an AI-Augmented Protocol Analysis tool, automating clinical trial protocol review and evaluation. Users can upload a protocol or draft, and the system analyzes it to identify potential risks, categorize them, and generate relevant risk statements. It then proposes mitigation actions and links appropriate key risk indicators based on previous trials' findings. The tool incorporates QbD principles, ensuring that risk assessments align with ICH E6 and E8 guidelines. AI algorithms analyze protocol elements systematically, offering suggestions for risk ratings while allowing manual review to make necessary adjustments. Launched in Q4 2023, this enhancement integrates with the "Ask-AI" feature, streamlining the risk identification process, reducing manual effort, and improving the ability to detect risks earlier.  

Brief Description of Innovative Technology: 
The AI-Augmented Protocol Analysis tool introduces an advanced method for automating clinical trial risk management by evaluating protocol components with built-in QbD principles. This technology analyzes the uploaded protocol, categorizes identified risks, and formulates risk statements in a workflow aligned with ICH E6 and E8 standards. AI-driven processes automatically generate risk statements, suggest mitigation actions, and link relevant key risk indicators, simplifying the traditional steps required in risk assessment. The tool’s capability to provide consistent risk evaluations and propose effective risk management strategies enhances decision-making early in trial planning. By integrating the AI-Augmented Protocol Analysis tool into the MyRBQM Portal, users can clearly focus on trial quality and safety, benefiting from more efficient and accurate risk assessment procedures. 

Exostar 
Exostar Clinical Trial Access Manager (CTAM V1) | Booth 3 
http://www.exostar.com 

Brief Description of Problem Addressed by Product:  
Clinical trial operations involve managing a complex array of applications, such as CTMS, EDC, and LMS, each requiring distinct user access management processes. Currently, sponsors and site personnel must handle user access manually, often relying on spreadsheets to track permissions, application access, and training statuses across multiple sites. This fragmented approach creates inefficiencies, as clinical teams must repeatedly update access across various systems. The administrative burden is particularly heavy when clinical operations teams are managing multiple trials simultaneously. Coordinating access across applications for numerous users at different trial sites is time-consuming, prone to errors, and delays study start-up and site activation. Ensuring compliance with regulatory requirements becomes more difficult when access data is scattered across various systems and spreadsheets, heightening the risk of non-compliance. The lack of centralized oversight makes collaboration between sponsors and site personnel more complicated, further slowing down trial operations. 

Brief Product Description & Technical Specifications: 
The Clinical Trial Access Manager (CTAM) is an integrated solution built on Exostar’s Secure Access Manager (SAM), designed to streamline application access management for clinical trial operations. CTAM centralizes the process for managing user access, application permissions, and compliance tracking across multiple trials and sites, reducing the administrative burden on sponsors and site personnel. CTAM automates user onboarding, role assignments, and provides real-time insights into user access and trial progress. What’s new in this release: Real-time dashboards: Provide immediate visibility into onboarding progress, user access, and compliance statuses. Automated subscription workflows: Allow for seamless management of application access and role assignment. Planned integration with Learning Management Systems (LMS) and Clinical Trial Management Systems (CTMS): Future updates will automate training verification and enhance compliance tracking. Role-based access control via Rule Box (planned): Will allow sponsors and site personnel to define policies based on job roles, automating the assignment of access permissions and administrative tasks at the trial and site levels. CTAM offers a streamlined, centralized solution to manage trial access efficiently, improving operational performance, security, and compliance. 

Brief Description of Innovative Technology: 
CTAM leverages innovative technology built on Exostar’s Secure Access Manager (SAM), providing a centralized solution for managing application access across clinical trials. Traditionally, clinical trial operations rely on fragmented systems and manual processes, often using spreadsheets to track user access, permissions, and compliance across multiple sites and applications. CTAM replaces this fragmented approach with automation and real-time visibility, improving operational efficiency. The real-time dashboards within CTAM offer immediate insights into user onboarding, access levels, and compliance statuses, empowering sponsors and site personnel with up-to-date information. This transparency allows for faster decision-making and more effective management of trial operations. Additionally, CTAM features automated subscription workflows, reducing the need for manual intervention in assigning application access and managing user roles. This automation ensures the right users are granted the appropriate permissions quickly and efficiently. Planned innovations include the Rule Box feature, which will introduce role-based access control. Sponsors will be able to define rules based on job roles, automatically assigning administrative privileges and access permissions at both the trial and site level. Further planned integration with LMS and CTMS will automate training verification and compliance tracking, providing a more comprehensive management solution for clinical trials. CTAM’s combination of automation, real-time tracking, and centralized access control represents a significant advancement in how clinical trial operations are managed, reducing administrative burdens and improving compliance. 

Greenphire  
Greenphire Patient Support -Travel + Logistics // Concierge | Booth 33 
https://greenphire.com/ 

Brief Description of Problem Addressed by Product:  
While much attention as of late has been focused on enabling remote / hybrid trials, getting to and from physical clinical trial sites remains a barrier and potential deterrent to trial participation. Confirmed in the 2023 CISCRP Perceptions and Insights Study, logistical factors were cited as being the most disruptive aspect of clinical trial participation. This can include logistical but also financial challenges, which can differ from participant to participant. In addition to patient burden, research sites also feel the weight of patient travel as they are often responsible for making arrangements – whether car rides, air travel and rail or even hotels and passport and visa support. These administrative obstacles are difficult to manage and can distract from and hinder the research itself. Through traditional methods, which require either participants getting themselves to the clinic via their own means or sites making arrangements on their behalf, it is challenging for sponsors and CROs to deliver a consistent and scalable patient and site experience. The core goal of our solutions and services is to simplify and standardize the management of participant logistics – eliminating the financial and emotional burdens for participants and removing the administrative headache for sites while giving sponsors greater financial control and transparency. 

Brief Product Description & Technical Specifications: 
We understand the complexity and global nature of clinical trials and how that impacts the ability of a patient to participate in a study and a site to provide patient care and conduct research. As such, over our 16+ years of experience supporting the industry, we have established a global travel & logistics service for sponsors and CROs to enable their studies to remove the onus and burden for participants and sites. Our legacy offering, which has been incredibly well received by sites and participants around the world, is made up of a global network of localized travel agents. In the past year, we have bolstered our service to be even more robust by introducing an additional layer of support. With the acquisition of Clincierge, a clinical trial logistics company, we have coupled our global network of travel agents with expert in-region Concierge Coordinators (90+ Coordinators across 40+ countries). What does this mean? It means that not only are all travel bookings handled but in the ‘Concierge’ model, participants are assigned a Concierge Coordinator who serves as their single, local language and regional point of contact for the study – facilitating communication with the research site, reviewing, approving and prepping all travel arrangements (car rides, flights, hotels/apartments, online ordering, documentation support, etc.), collecting and submitting receipts for reimbursement, keeping track of study visits / requirements and more. 

Brief Description of Innovative Technology: 
In tandem with our concierge service, we have developed a new robust travel portal. This serves as a central location where sites, Concierge Coordinators and travel agents can interact. Sites and/or Concierge Coordinators can easily enter details about visit and participant requirements and travel agents can view requests in order to complete the necessary bookings. All details and required actions are captured and clearly documented within the portal, ensuring all parties who are supporting the participant can stay on top of their tasks and maintain a view into status. In addition to the travel portal, our GreenSpace mobile and web app serves as the participant’s single location to view study details. This includes financials (reimbursements, balance, receipt submissions, etc.), travel information (e.g., car ride status tracking) and study-related insights. Overall, our new combined concierge solutions and services ensure a seamless experience across all stakeholders from sites, Concierge Coordinators and travel agents to patients and caregivers – driving enhanced site satisfaction and improved participant engagement and retention. In all, Greenphire is committed to investing in the areas global sponsors need - from our flagship patient payments solution - ClinCard, to our expanded travel and logistics program, offering a one-stop-shop to enable a consistent and robust vision for improving the patient experience and reducing drop out, and more effective and efficient clinical trials. 

Inetsys S.L 
ShareCRF RBM | Booth 48
https://www.sharecrf.com

Brief Description of Problem Addressed by Product:

Imagine you already have a risk-based monitoring (RBM) strategy defined for your clinical study. You know exactly which variables to review and for which patients, but the EDC you are using cannot implement that strategy directly. You find yourself forced to work with parallel processes, external spreadsheets, or additional tools. What should be a centralised process turns into a puzzle full of potential errors. It's frustrating. You know what needs to be done, but you don't have the right tools. Every time you need to check progress, you have to cross-reference information from different systems and manually adjust the reviews. It's like trying to dig a well with your bare hands instead of using a spade: the work becomes much harder, slower, and more exhausting. With the new functionality of ShareCRF, everything changes. You can directly implement the RBM strategy from the EDC, without parallel processes. You can assign different SDV strategies to patients, based on the RBM strategy you have defined for the study. ShareCRF will automatically indicate which variables need to be reviewed and will show, in real time, the pending data at the patient, site, or study level. Everything is integrated and synchronised. Risk-based monitoring becomes a natural part of the study, with no extra effort, no duplicated work, and no uncertainty. This way, you can ensure data quality, optimise resources, and always maintain complete control over your clinical trial. Ready to stop struggling and use the right tool?

Brief Product Description & Technical Specifications:

ShareCRF offers an advanced feature that enables to assign a distinct Source Data Verification (SDV) strategy for each patient, allowing for an efficient, risk-based monitoring process tailored to your clinical study. This functionality ensures that variables requiring review are clearly marked based on each patient’s SDV strategy, allowing for quick identification and providing a clear view of the data that requires attention. With ShareCRF, each patient can have a customised SDV strategy assigned based on study requirements, site characteristics, patient risk profile, or any other variable that you wish to use. This approach means that monitors can focus on the fields needing verification, enabling a more targeted process. The system automatically highlights what requires review, significantly streamlining the workflow and reducing oversight risk. ShareCRF also provides real-time SDV progress tracking. Monitors can easily see verified and pending fields, maintaining control over data quality. Reporting tools generate detailed insights into verification status, optimising monitoring visits and logistics. With a clear view of tasks, monitoring visits can be better planned, ensuring efficient use of resources. This feature is fully integrated within the ShareCRF EDC, eliminating the need for parallel processes or external spreadsheets. By keeping all SDV and monitoring activities within one platform, ShareCRF simplifies trial management, reduces errors, and provides full visibility and control over data verification. With ShareCRF, you can enhance clinical trial monitoring, optimising resources while ensuring seamless reviews.

Brief Description of Innovative Technology:

ShareCRF incorporates a technological innovation that provides unprecedented versatility in risk-based monitoring (RBM). The RBM strategy designer can define as many Source Data Verification (SDV) strategies as needed, adapting to the specific characteristics of the study, the site, or patient profiles. This flexible configuration capability means that different strategies can be adjusted for different groups of patients, sites, or phases of the trial. Not only is it possible to define multiple strategies, but they can also be modified throughout the study, or even new strategies added as additional needs arise or the clinical trial context changes. This dynamic updating capability ensures that the system remains aligned with the real needs of the study at all times. Every time a change is made to the strategy configurations, ShareCRF automatically updates the system's data, ensuring that monitors always have access to the most up-to-date information. This means that the fields to be verified are immediately adjusted according to the new guidelines, allowing for much more agile and precise SDV management. Thanks to this innovation, ShareCRF offers enormous versatility, making risk-based monitoring as dynamic as the study's own needs. This translates into better resource optimisation, greater monitoring efficiency, and superior data quality, quickly adapting to any changes the study requires.

 
Medidata, Dassault Systèmes 
Medidata Clinical Data Studio | Booth 30 
https://www.medidata.com/en/clinical-data-studio/ 

Brief Description of Problem Addressed by Product:  
Clinical data management and risk/safety monitoring teams face significant challenges as they are transformed from being stewards of EDC data integrity to stewards of all data and overall data quality, including: - Slow implementation of AI approaches - Low adoption of RBQM (Risk-Based Quality Management) concepts - Poor integration across different systems Medidata Clinical Data Studio addresses these challenges, delivering a consistent user experience that increases data quality management effectiveness by reducing user burden, shortening cycle times, increasing data quality, and reducing risk. 

Brief Product Description & Technical Specifications: 
Clinical Data Studio, launched in June 2024, is a data source agnostic experience that orchestrates data integration, standardization, reconciliation, and quality management across multiple sources. Designed to simplify the complex data lifecycle by connecting numerous data sources with a streamlined data ingestion and standardization engine, Clinical Data Studio accelerates activities for clinical data management and operations teams by integrating data review and risk management capabilities in a consistent, collaborative user experience. Clinical data managers/scientists, programmers, central monitors, and medical monitors work together, on all data, in one experience, powered by automation, analytics, and AI to accelerate data review workflows, mitigate data quality risks, and help ensure patient safety. This solution combines advanced capabilities for data review, medical/safety monitoring, risk management, and centralized statistical monitoring with a no/low-code experience for ingesting, validating, standardizing, and integrating/transforming data from multiple sources. 

Brief Description of Innovative Technology: 
Clinical Data Studio has a positive impact on data quality through powerful capabilities simplified in an intuitive experience: Streamlined self-service data ingestion agnostic of source - Automated, real-time data review, reconciliation, and surveillance - Risk management and central monitoring - Self-serve dynamic visualizations for real-time safety monitoring - Bulk query management and external data vendor communication connection - Embedded AI and ML capabilities, including anomaly detection, data reconciliation, and data transformation - Flexible Clean Patient Tracker for an ongoing task and data cleanliness progress tracking - Transformation engine for low code data standardization and SDTM-like dataset creation Comparing Clinical Data Studio with traditional manual or programming methods, we’ve seen that it enables: - The solution to be up and running in as little as 3 days - Listings to be built up to 90% faster - Bulk queries to be generated in less than 1 minute - Data review cycle times to be shortened by up to 80% per cycle - Patient profile review time to be shortened by up to 50% - KRIs (Key Risk Indicators) and QTLs (Quality Tolerance Limits) can be configured up to 85% faster Templates and libraries also allow for the quick reuse of listings, KRIs, and QTLs within and across studies. 

myTomorrows 
myTomorrows Platform, Version 1.3 | Booth 49 
https://mytomorrows.com/ 

Brief Description of Problem Addressed by Product:  
Physicians face a significant challenge in finding appropriate clinical trials for their patients. Public registries, like clinicaltrials.gov, are cumbersome and often require a substantial investment of time to sift through complex eligibility criteria and navigate dense databases. In particular, this process is a hindrance for physicians when searching for possible treatments. As a stakeholder that has limited time, a process which is so time-consuming can be a significant barrier. The knock-on effect is that all patients may not be presented with all possible treatment options. Furthermore, trial sites and BioPharma clinical studies struggle to meet referral and enrollment goals - in fact, 80% of clinical trials globally fail to meet their enrollment goals1. There is a domino effect felt across all stakeholders within the pre-approval ecosystem (see source). myTomorrows addresses these issues by simplifying clinical trial searches, eligibility pre-screening, and direct communication with trial sites, ultimately enhancing trial accessibility and efficiency for physicians, research teams and patients. Source 1: The National Center for Biotechnology Information, National Library of Medicine, Recruitment and retention of participants in clinical studies: Critical issues and challenges, Mira Desai, May 2020; ‘80% of clinical trials globally fail to meet recruitment goals on time 

Brief Product Description & Technical Specifications: 
myTomorrows offers an innovative platform designed to streamline the clinical trial process for physicians, clinical research teams, patients, and their caregivers. The key features include an intuitive interface for comprehensive trial searches, AI-assisted pre-screening for healthcare professionals to check patient eligibility for relevant trials, and direct communication tools for trial sites. Unlike the conventional experience of finding and accessing clinical trials via individual public registries, which stops at information provision, myTomorrows pulls together information from multiple public registries in over 200+ countries. This allows physicians to complete the trial discovery and access journey of searching, pre-screening, and referring in a streamlined single transaction. New in the latest release is integrated AI pre-screening for more precise eligibility checking benefiting both the user and the trial site. The platform now also offers a secure communication environment between physicians and myTomorrows' Patient Navigators on one side, and trial sites on the other, where medical documents, PII, and AI eligibility checks can be shared. Whether managing low or high volumes of referrals, myTomorrows ensures more efficient trial recruitment and better-quality patient leads. 

Brief Description of Innovative Technology: 
Via our state-of-the-art technology, myTomorrows indexes multiple registries (including clinicaltrials.gov, clinicaltrialsregister.eu and ISRCTN) in order to curate one holistic search engine which provides a unique and comprehensive overview for the majority of trials worldwide. On the platform, the use of AI in a proprietary assistant-like interface speeds up eligibility checking by up to 90%. Contacting the site, for requesting information or making a referral, is enabled securely on-platform in a GDPR and ISO-compliant way. This also allows PII, medical documents and other information to be shared more securely than over e-mail. For trial sites, the AI pre-screening is integrated into their communication environment, speeding up eligibility checking. 

Validated Cloud  
Life Science Community Cloud for Regulated Systems | Booth 29 
https://www.validatedcloud.com/ 

Brief Description of Problem Addressed by Product:  
Validated Cloud offers a secure, compliant cloud solution tailored specifically for the life sciences and pharmaceutical industries, where stringent regulatory standards like FDA, GxP, EMA and GDPR make using traditional cloud services complex and risky. These industries face the challenge of ensuring that their cloud environments meet strict compliance requirements, and building a compliant infrastructure in-house (DIY) often demands significant time, resources, and cost. As a community cloud dedicated to Pharma and Life Sciences, Validated Cloud provides a fully validated, audit-ready platform that simplifies the compliance process. It eliminates the need for companies to invest in extensive validation efforts and ongoing management, offering a reliable, scalable solution that meets all regulatory requirements from the start. By choosing Validated Cloud, organizations avoid the high costs, delays, and operational burdens of a DIY approach, while still benefiting from the flexibility and efficiency of the cloud. This specialized solution allows companies to focus on their core business and innovation, confident that their cloud infrastructure is secure, compliant, and ready to meet industry standards. 

Brief Product Description & Technical Specifications: 
Validated Cloud is a specialized community cloud designed for life sciences and pharmaceutical companies, providing a secure, compliant, and audit-ready environment. It ensures regulatory compliance while offering scalable infrastructure and services tailored to the industry's needs. Key Features and Specifications: IaaS (Infrastructure as a Service): Provides a scalable, validated infrastructure with enterprise-grade security and high availability, enabling companies to run mission-critical applications in a fully compliant environment. PaaS (Platform as a Service): Offers a robust platform for developing, testing, and deploying applications with integrated compliance features, allowing life sciences companies to accelerate innovation while maintaining regulatory integrity. VaaS (Validation as a Service): Software Validation per 21 CFR Part 820 – VaaS™ is a dynamic FDA compliant software validation and quality system development service that addresses many compliance needs both inside and outside of Validated Cloud. Assistance with software validation, validation maintenance, for software hosted with Validated Cloud or elsewhere. Validated Cloud provides audit preparedness prior to regulatory or third-party audits. Validated SAS: Design, hosting and support of SAS ® instances, providing companies with tailored solutions that will ensure scalability, compliance and security. GxP-Compliant S3-Compatible Storage: Offers secure, scalable storage compatible with the S3 standard, designed to meet GxP requirements for data integrity, traceability, and long-term retention. It ensures compliance for regulated data while providing high performance and flexibility. Managed Services: 24/7 monitoring, proactive maintenance, and compliance management, with dedicated support to ensure continuous operation, security, and audit readiness. Validated Cloud is a complete solution, providing IaaS, PaaS, VaaS, validated SAS, and compliant storage—all optimized for life sciences and pharma. It reduces the time, cost, and effort of managing cloud infrastructure while ensuring regulatory compliance. 

Brief Description of Innovative Technology: 
Validated Cloud was purpose-built for the pharmaceutical and life sciences industries, with every element designed, documented, and governed to meet the strict regulatory standards these sectors require. 1. Automated Validation (VaaS) Our Validation as a Service (VaaS) automates the validation process for cloud infrastructure and applications, ensuring compliance with GxP, FDA 21 CFR Part 11, and HIPAA. This reduces manual validation efforts and provides audit-ready documentation tailored to industry regulations. 2. Validated Solutions We offer Validated SAS and other validated software solutions for key functions like clinical trials and R&D. These applications meet strict regulatory standards, allowing clients to implement them quickly without additional validation efforts. 3. Compliance-First Infrastructure Our IaaS and PaaS are built with compliance at their core. From encryption and access controls to audit trails, every feature is designed to meet the specific regulatory requirements of Pharma and Life Sciences, ensuring continuous compliance. 4. GxP-Compliant S3-Compatible Storage Our GxP-compliant, S3-compatible storage is designed to ensure data integrity, traceability, and retention. Automated backups and disaster recovery are built-in to securely manage regulated data. 5. 24/7 Monitoring & Managed Services We provide 24/7 monitoring, proactive compliance management, and dedicated support to keep systems secure, compliant, and always audit-ready. At Validated Cloud, everything we do is designed to comply with the stringent regulations governing Pharma and Life Sciences.