eClinical Solutions
  • Products
    • Mapper
    • Data Central
    • Clinical Analytics
    • Operational Insights
    • Risk-Based Quality Management
    • Statistical Computing Environment
  • Services
    • Clinical Data Acquisition
    • Clinical Data Management
    • Data Conversion and Standardization
    • Biostatistics and Statistical Programming
    • Functional Service Provider
    • elluminate Implementation
  • Clients
    • For Data Management
    • For Clinical Operations
    • For Medical Monitoring
    • For Biostatistics
    • For R&D IT
    • For Clinical Programming
  • Learn
    • Events
    • elluminate Engage
    • Webinars
    • eClinical Academy
    • Blog
    • Tufts Research
    • Client Stories
    • Videos
    • White Papers
    • Roadmap to Digital Transformation Series
  • About
    • Leadership
    • Careers
    • Partners
    • In the News
    • Press Releases
    • Events
    • Webinars
    • Blog
  • Contact Us
  • Request a Demo
  • Products
      • Platform


      • elluminate Clinical Data Cloud

        One platform for data from ingestion to insights

      • Overview
      • Clients
      • Implementation
      • Trust and Privacy
      • Learn
      • Request a Demo
      • Products


        • Mapper – Map and standardize without programming
        • Data Central – Integrated data review and management
        • Clinical Analytics – Clinical and operational analytics across sources
        • Operational Insights – Manage your trial operations with a data-driven approach
        • Risk-Based Quality Management – Holistic risk management and monitoring
        • Statistical Computing Environment – Accelerate and automate statistical analyses
        • For Every Role


          • Data Management
          • Clinical Operations
          • Medical Monitoring
          • Biostatistics
          • R&D IT
          • Clinical Programming
  • Services
      • Services Approach


      • Clinical Biometrics Services

        Expert biometrics services accelerated by people and technology

      • Overview
      • Clients
      • Products
      • Careers
      • Learn
      • Request a Proposal
      • Services


        • Clinical Data Acquisition – Design and implementation for innovative trials
        • Clinical Data Management – Integrated clinical trial data management services
        • Data Conversion and Standardization – Services streamline data analysis and submission
        • Biostatistics and Statistical Programming – Strategic statistical input and programming
        • Functional Service Provider – Flexible and scalable program-level support
        • elluminate Implementation – Dedicated elluminate enablement and success
        • For Every Role


          • Data Management
          • Clinical Operations
          • Medical Monitoring
          • Biostatistics
          • R&D IT
          • Clinical Programming
        • Urovant Integrated Summary of Safety (ISS) Case Study – Urovant streamlines ISS submission prep and planning with eClinical Solutions’ biostatistics and statistical programming services and elluminate
        • View case study
  • Clients
      • Clients


      • Powering Life Science Innovators

        Helping clients digitize and transform clinical data

      • See all
      • Products
      • Services
      • About eClinical
      • Learn
      • Request a Demo
        • Customer Stories


        • Agios Pharmaceuticals
        • bluebird bio
        • Bristol Myers Squibb
        • Cerevel
        • See All
        • Partners


        • eClinical Partners
        • For Every Role


          • Data Management
          • Clinical Operations
          • Medical Monitoring
          • Biostatistics
          • R&D IT
          • Clinical Programming
        • BMS elluminate Clinical Data Cloud Case Study – BMS adopts a unified clinical data architecture with the elluminate Clinical Data Cloud as the foundation for data access across sources
        • View case study
  • Learn
      • Learn


      • Digital Clinical Learning Center

        The latest resources to help you solve data challenges

      • See all
      • Products
      • Services
      • Clients
      • About eClinical
      • Request a Demo
        • Events and Webinars


        • Events
        • elluminate Engage
        • Webinars
        • eClinical Academy
        • Resources


        • Blog
        • Tufts Research
        • Client Stories
        • Videos
        • White Papers
        • Roadmap to Digital Transformation Series
        • See All
        • For Every Role


          • Data Management
          • Clinical Operations
          • Medical Monitoring
          • Biostatistics
          • R&D IT
          • Clinical Programming
        • eClinical Solutions Blog – Stay up to date with the latest posts and perspectives to help guide your digital data transformation strategies
        • Read the blog
  • About
      • About


      • Leading the eClinical Evolution

        Experienced life science leaders driving data innovation

      • Learn more
        • Company


        • Leadership
        • Careers
        • Partners
        • News


        • In the News
        • Press Releases
        • Events
        • Webinars
        • Blog
        • Connect


          • Contact Us
        • Careers at eClinical Solutions – Accelerate your career, shape the future of life sciences and make your contribution to helping bring therapies to patients faster
        • Learn more
  • Request a Demo
  • Contact Us

Digital Clinical Architecture for Modern Researchers

Applied Clinical Trials
Publication: Applied Clinical Trials
Published: September 16, 2022
Share:

Clinical trials are evolving rapidly, making it harder to handle the increasing volume of data available today. Real-time access to this data is crucial to bring groundbreaking new therapies to market. We sat down with Raj Indupuri from eClinical Solutions and Douglas Barta from Cerevel Therapeutics to discuss how a digital clinical architecture is ideal for modern researchers and trials.

Applied Clinical Trials: We know that data plays a major role in clinical trials. How do researchers handle the volume and variety of data sources?

Raj Indupuri: Today’s clinical research teams work with an incredible amount of data. In 2021, phase III clinical trials generated 300% more data points than 10 years prior, according to the Tufts Center for the Study of Drug Development (CSDD), now a million data points on average. However, it’s not just the amount of data that’s harder to manage, it’s the increase in different data sources too. In separate research we conducted with Tufts CSDD, more than two-thirds of all sponsors reported using or piloting at least four data types in clinical trials, including non-CRF data, direct data capture, data from devices and apps, medical images, electronic health records (EHRs) and omics data. In 2022, we see trials averaging 10 unique data sources. To handle all this data, life sciences companies are looking for ways to automate digital data flows including data ingestion, mapping and standardization processes and analytics to support end user teams to clean and review data faster while supporting streamlined decision making and faster insights.

Douglas Barta: In my experience, life sciences companies are looking for innovative strategies to manage numerous data streams coming in from multiple trials to handle the volume, variety and velocity of modern clinical trials. We chose to take a digital first approach and want to maximize flexibility and speed in our trials to ensure clinical teams can choose the best possible providers and technologies that meet the needs of participants and scientific objectives. Sprinkling data across numerous sources is not the approach we wanted to take. One data platform that enables near real-time analysis to help make better business decisions rapidly across teams is a strategic and competitive advantage.

ACT: When looking to implement this type of technology platform, you had the opportunity to buy one or consider building your own. What was the strategy behind your approach?

DB: In recent years there has been a major shift for life sciences companies to buy versus build technology, with more software providers and options available. Buying saves time and money and avoids investing in a team focused outside the core competency of new drug development. We chose to buy a data and analytics cloud including data repositories, workbenches, connectors and out of the box analytics and use it as a foundational platform for our trials. Implementation is faster when working with a software company that does this frequently, and there are always new features to utilize. For companies like ours with the opportunity to design a data architecture from scratch, the benefits of buying far outweighed those of building.

ACT: Why is a centralized platform approach necessary when designing a modern digital clinical architecture?

RI: As trial complexity evolves, a comprehensive data and analytics platform gives researchers the control to quickly examine data from all necessary perspectives. Data flow is automated and rapidly turned into information and insights. Data can be arranged, combined, rearranged, and traced from the original source for better governance, transparency and traceability.

These platforms also help teams collaborate more efficiently with one source of truth and set of visualizations that quickly shows outliers and areas of concern. Many teams still rely on cumbersome, manual Excel trackers and line listings to review data and monitor trials. Instead they could be using a comprehensive platform to transform their data into analytics, risk indicators and actions that enable faster decision-making and can speed cycle time and improve overall data quality.

DB: One of the greatest challenges facing clinical trials today is timely recruitment of participants and incorporating diverse populations in clinical trials. As sponsors optimize their diversity, equity, and inclusion (DEI) strategies, ensuring plan success is partially a data and analytics problem. Clinical teams need real-time visibility to screening and enrollment demographic analytics by geography and cohort, which often come from multiple source systems. Utilizing a central data infrastructure helps teams operationalize their DEI best practices and gain the oversight necessary to measure results. In parallel, trial designs that incorporate Decentralized Clinical Trial (DCT) designs and technology can help improve the patient experience and make participation in the trial more convenient. The ability to easily incorporate DCT data into digital trials along with numerous other data sources for rapid review and cleaning is another advantage of a centralized data and analytics platform. As we look to the future state of digital trials and clinical development, we know there will continue to be new data streams that will enhance researchers’ knowledge of patient experience that we are ready to take advantage of.

ACT: How do you see this technology continuing to advance? Any trends or predictions?

RI: Data is the currency of life sciences and all the trends we discussed are accelerating. Technology is advancing not only the ways we gather information, but how we standardize and process data. Embracing new trends in data automation, organization and analytics will continue to help research teams make breakthroughs more efficiently. The democratization of data has created greater demand for technology in life sciences that transforms data into insights across all areas of the development process. We see incredible growth and opportunities to build artificial intelligence and predictive analytics on top of centralized data platforms that augment end user knowledge and skill sets, speed the pace of research and advance human health.

DB: At Cerevel, we are constantly asking ourselves how we can do better for patients, researchers, and our teams. We will continue to invest in technology, analytics and platforms that deliver a better experience to trial participants and our researchers.

Raj Indupuri
CEO, eClinical Solutions

A technologist with over 25 years of industry experience, Raj Indupuri is responsible for establishing the eClinical Solutions vision and future-looking technology strategy. He is deeply passionate about fostering innovation to revolutionize the Life Sciences industry with ground-breaking technologies that will modernize clinical trials and bring treatments to patients faster. As an industry veteran who has been part of the evolution of Life Sciences and clinical data management for over two decades, Raj has an astute business vision to realize the digital future and enable progress and potential with data and analytics at the core of the company’s innovative products and solutions. Raj is responsible for the overall direction and management of the company and is a Mechanical Engineer with an MBA from Boston University who firmly believes data is the new fuel that will drive human progress.

Douglas Barta
CIO, Cerevel Therapeutics

Doug Barta currently serves as the Chief Information Officer of Cerevel Therapeutics, a leading neuroscience biopharmaceutical company based in Boston. Before Cerevel, Mr. Barta served as CIO of Parexel, where he oversaw technology globally for this $2+B CRO. Prior to Parexel, Mr. Barta was CIO of a Marsh & McLennan company, Guy Carpenter, a leading reinsurance brokerage and before that, he spent over seven years with Fidelity, where he completed his tenure as the COO of Fidelity Asset Management Technology. Mr. Barta is a Wharton MBA and a Cornell University Electrical Engineer.

Contact Us

Fill out the form below to schedule a demo and/or speak to an eClinical Solutions representative to learn more about elluminate.

We're committed to your privacy. eClinical Solutions uses the information you provide to us to contact you about our relevant content, products, and services. You may unsubscribe from these communications at any time. For more information, check out our Privacy Policy.

News
Raj IndupuriDouglas Barta

Related Content

Life Science Success

Raj Indupuri – CEO eClinical Solutions

Posted in: News, Podcasts

Ten Years of eClinical: 10 Predictions for 2023 and Beyond

Posted in: Blog

Ten Years of eClinical: 10 Key Company Milestones

Posted in: Blog

Recent News

Life Science Success

Raj Indupuri – CEO eClinical Solutions

January 11, 2023
Fast Company

The evolving role of a business leader: 10 lessons learned from the past decade

December 9, 2022
Pharmaceutical Outsourcing

How to Improve Diversity in Clinical Trials: Achieving an Industry Imperative

December 9, 2022

Categories

  • Blog
  • Case Studies
  • Events
  • Fact Sheets
  • News
  • Videos
  • Webinars
  • White Papers
  • Products
  • Mapper
  • Data Central
  • Clinical Analytics
  • Operational Insights
  • Risk-Based Quality Management
  • Statistical Computing Environment
  • Services
  • Clinical Data Acquisition
  • Clinical Data Management
  • Data Conversion and Standardization
  • Biostatistics and Statistical Programming
  • Functional Service Provider
  • elluminate Implementation
About & Resources
  • Clients
  • Learn
  • Events
  • About
  • Leadership
  • Press Releases
  • Careers
  • Partners
  • Contact Us
  • Support

Subscribe to eClinical Insights and News

Get data strategy resources delivered to your inbox

We’re committed to your privacy. eClinical Solutions uses the information you provide to us to contact you about our relevant content, products, and services. You may unsubscribe from these communications at any time. For more information, check out our Privacy Policy.

  • LinkedIn
  • Twitter
  • YouTube

© eClinical Solutions LLC. All rights reserved. elluminate® is a registered service mark of eClinical Solutions LLC.

  • Privacy Policy
  • Trust and Privacy
  • Legal
  • Contact Us

Upcoming Webinar:
The Foundation of Your Digital Trials

Register Now
X
Scroll Up