-
Americas
-
Asia & Oceania
-
A-I
J-Z
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more -
Middle East & Africa
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Regions
-
Americas
-
Asia & Oceania
-
Europe
-
Middle East & Africa
-
Americas
-
Asia & Oceania
-
Europe
Europe
- Adriatic
- Belgium
- Bulgaria
- Czech Republic
- Deutschland
- España
- France
- Greece
- Hungary
- Ireland
- Israel
- Italia
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more -
Middle East & Africa
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
SOLUTIONS
-
Research & Development
-
Real World Evidence
-
Commercialization
-
Safety & Regulatory Compliance
-
Technologies
LIFE SCIENCE SEGMENTS
HEALTHCARE SEGMENTS
- Information Partner Services
- Financial Institutions
- Public Health and Government
- Patient Associations
- Payers
- Providers
THERAPEUTIC AREAS
- Cardiovascular
- Cell and Gene Therapy
- Central Nervous System
- GI & Hepatology
- Infectious Diseases and Vaccines
- Oncology
- Pediatrics
- Rare Diseases
- View All
Impacting People's Lives
"We strive to help improve outcomes and create a healthier, more sustainable world for people everywhere.
LEARN MORE
Harness the power to transform clinical development
Reimagine clinical development by intelligently connecting data, technology, and analytics to optimize your trials. The result? Faster decision making and reduced risk so you can deliver life-changing therapies faster.
Research & Development OverviewResearch & Development Quick Links
Real World Evidence. Real Confidence. Real Results.
Generate and disseminate evidence that answers crucial clinical, regulatory and commercial questions, enabling you to drive smarter decisions and meet your stakeholder needs with confidence.
REAL WORLD EVIDENCE OVERVIEWReal World Evidence Quick Links
See markets more clearly. Opportunities more often.
Elevate commercial models with precision and speed using AI-driven analytics and technology that illuminate hidden insights in data.
COMMERCIALIZATION OVERVIEWCommercialization Quick Links
Service driven. Tech-enabled. Integrated compliance.
Orchestrate your success across the complete compliance lifecycle with best-in-class services and solutions for safety, regulatory, quality and medical information.
COMPLIANCE OVERVIEWSafety & Regulatory Compliance Quick Links
Intelligence that transforms life sciences end-to-end.
When your destination is a healthier world, making intelligent connections between data, technology, and services is your roadmap.
TECHNOLOGIES OVERVIEWTechnology Quick Links
CLINICAL PRODUCTS
COMMERCIAL PRODUCTS
COMPLIANCE, SAFETY, REG PRODUCTS
BLOGS, WHITE PAPERS & CASE STUDIES
Explore our library of insights, thought leadership, and the latest topics & trends in healthcare.
DISCOVER INSIGHTSTHE IQVIA INSTITUTE
An in-depth exploration of the global healthcare ecosystem with timely research, insightful analysis, and scientific expertise.
SEE LATEST REPORTS
FEATURED INNOVATIONS
-
IQVIA Connected Intelligence™
-
IQVIA Healthcare-grade AI™
-
Human Data Science Cloud
-
IQVIA Innovation Hub
-
Decentralized Trials
-
Patient Experience powered by Apple
WHO WE ARE
- Our Story
- Our Impact
- Commitment to Public Health
- Code of Conduct
- Environmental Social Governance
- Privacy
- Executive Team
NEWS & RESOURCES
Unlock your potential to drive healthcare forward
By making intelligent connections between your needs, our capabilities, and the healthcare ecosystem, we can help you be more agile, accelerate results, and improve patient outcomes.
LEARN MORE
IQVIA AI is Healthcare-grade AI
Building on a rich history of developing AI for healthcare, IQVIA AI connects the right data, technology, and expertise to address the unique needs of healthcare. It's what we call Healthcare-grade AI.
LEARN MORE
Your healthcare data deserves more than just a cloud.
The IQVIA Human Data Science Cloud is our unique capability designed to enable healthcare-grade analytics, tools, and data management solutions to deliver fit-for-purpose global data at scale.
LEARN MORE
Innovations make an impact when bold ideas meet powerful partnerships
The IQVIA Innovation Hub connects start-ups with the extensive IQVIA network of assets, resources, clients, and partners. Together, we can help lead the future of healthcare with the extensive IQVIA network of assets, resources, clients, and partners.
LEARN MORE
Proven, faster DCT solutions
IQVIA Decentralized Trials deliver purpose-built clinical services and technologies that engage the right patients wherever they are. Our hybrid and fully virtual solutions have been used more than any others.
LEARN MORE
IQVIA Patient Experience Solutions powered by Apple
Empowering patients to personalize their healthcare and connecting them to caregivers has the potential to change the care delivery paradigm. IQVIA and Apple are collaborating to bring this exciting future of personalized care directly to devices patients already have and use.
LEARN MOREWORKING AT IQVIA
Our mission is to accelerate innovation for a healthier world. Together, we can solve customer challenges and improve patient lives.
LEARN MORELIFE AT IQVIA
Careers, culture and everything in between. Find out what’s going on right here, right now.
LEARN MORE
WE’RE HIRING
"Improving human health requires brave thinkers who are willing to explore new ideas and build on successes. Unleash your potential with us.
SEARCH JOBSBlog
AI and RBM: Is this the future of clinical trials?
How smart technology brings speed, quality and accuracy to risk monitoring tasks.
Apr 11, 2022
There is digital evolution occurring across all aspects of clinical research. Advanced analytics tools that use artificial intelligence and machine learning (AI/ML) give research teams the power to make sense of the vast data being collected through clinical research. These tools enable advanced statistical predictive modelling and process automation to enhance overall study quality while freeing staff to focus more on highlighted critical items.
This includes the adoption of Risk Based Monitoring (RBM) to manage the flood of new data coming into the clinical data environment from eSource, eConsent, eISF, EMR and other digital sources. This data offers a wealth of valuable information, but only if companies have the technology to comb the data coming in with a focus on driving quality and efficiency. To accommodate this shift, sponsors need more comprehensive dataflow management technologies that use AI/ML to streamline review and decision-making processes.
AI/ML-driven data management doesn’t just accelerate data capture or provide generalized insights. These platforms seamlessly integrate large volumes of data from a breadth of sources, and feature automation tools to streamline the review process.
The most sophisticated solutions, like IQVIA’s Central Monitoring (CM) platform, clean and house all data in a single location, and use custom machine learning algorithms to identify data errors, outliers, and false entries.
The analytical engine features natural language processing capabilities, which means it can identify site or study risks in both structured and unstructured data. The AI/ML features enable predictive analytics that can improve patient safety and site performance by detecting and mitigating potential issues.
When risks are found, the platform can provide alerts and produce dashboards summarizing RBM analyses and updates, all with little or no human interaction. This includes predicting protocol deviations, which can cause safety concerns for patients and delays in project delivery. In one recent project, the platform analyzed historical trend data to predict when protocol deviations were most likely to occur, allowing the monitoring team to proactively implement mitigation actions. The model showed over 70% prediction accuracy, and it was able to detect ~100% of protocol deviations within data reviews.
The impact of such predictive analytics can be substantial for monitors, sites, and the patients they treat.
AI/ML streamlines data review
It also brings greater efficiencies and job satisfaction. By automating the data collection, cleaning and review process, CRAs are free to focus on more value-added tasks, and sponsors and sites get faster access to information.
IQVIA has worked with several large organizations to help them enhance quality and efficiency in their projects. In one example, a large pharma company running a global trial came to IQVIA for help in accelerating their RBM process while reducing burden for staff.
The sponsor was already using central monitors to support CRAs in the field but they wanted to further streamline the data review. Prior to the deployment of the AI/ML system, alerts for site risks were managed through manual processes where human monitors reviewed all the data then decided whether a risk warranted an action item, or that no action was required.
This process required many hours from a limited staff who were becoming overburdened by the volume of data to review.
As a solution, they deployed IQVIA’s Alert Automation, which is part of IQVIA’s RBM platform. Machine learning algorithms were trained using data from past trials to analyze and predict risks and determine the appropriate response. When a risk is identified, the platform automatically assigns the appropriate actions and sends an action alert to the team, freeing the monitors and site staff to focus on solutions rather than data review tasks.
A review of the implementation found that the AI/ML technology matched decisions made by experts more than 90 percent of the time, while reducing the number of hours required to complete RBM tasks by 75 percent.
This is the future
Monitors are continuously looking for ways to speed data review and the identification of potential safety concerns for patients. AI/ML-driven RBM platforms can deliver the insights they need.
Advanced analytics technologies are becoming a must for RBM, especially in high data-volume environments. When these tools can rapidly capture and analyze the deluge of data coming from multiple sources and identify potential risks it speeds decision making and can improve data quality across the entire clinical environment.
As these tools become the norm, it will soon pave the way for predictive and proactive signal detection, driving more robust safety insights and a more efficient environment.
Moving into the future such AI-driven innovation and flexibility will be paramount for clinical trial success. It does require some digital transformation disruption as sponsors transition to a RBM model and embrace automation, but the quality and cost benefits will make this transition a worthy journey to take.
Related solutions
Patient Recruitment
Predict enrollment more accurately and increase the number of patients per site using data-driven patient recruitment solutions.
Clinical Trials
Change the model of clinical research by integrating data, expertise, analytics and technology from study design through execution to power better decisions.
Clinical Research & Development Solutions
Explore our end-to-end, full service clinical development capabilities including Therapeutics expertise, Development Planning, Phase I early clinical development, Phase IIb/III and Phase IV Trials, Regulatory Submission and Post-Launch Studies.