Webinar on Maximizing Clinical Data Interoperability & Accelerating Clinical Trials

Navitas Life Sciences and ThoughtSphere are delighted to present this interactive webinar to explore the power of data harmonization and system interoperability in clinical trials. Join our experts as they share their first-hand experience with meta-data driven system interoperability and showcase its downstream benefits, including novel data insights and the ability to synchronize and automate centralized and risk-based data review workflows.

During the webinar, our experts will delve into the challenges surrounding clinical data interoperability and showcase three compelling use cases that demonstrate how enhanced efficiency can be achieved. From harnessing the power of advanced technologies to streamlining data management and data reporting, this webinar promises to offer actionable insights that can transform the landscape of clinical trials.

This webinar is an excellent opportunity to stay at the forefront of clinical data science and gain a deeper understanding of the latest advancements in the field.

Navitas Life Sciences

At Navitas Life Sciences, we understand that every clinical trial forges towards groundbreaking discoveries and life-saving treatments. That's why we offer comprehensive, insights-driven solutions that cover every aspect of the clinical trial journey. From seamless operations, therapeutically driven medical management, safety to clinical data services– we've got efficient solutions from start to finish.

As a leading global CRO, Navitas Life Sciences offers a suite of services to pharmaceutical, life sciences companies and US Federal agencies, with 600+ clinical trials across 20+ therapeutic areas, including Oncology, CNS, Infectious Disease and clinical registries support.

We met with Dr Yun Lu, Vice President and Chief Science and Innovation Officer, Navitas Clinical Research and Christina Dinger, Senior Director of Product, ThoughtSphere to find out more about the webinar and what is in store for attendees.

Dr Yun Lu

Vice President and Chief Science and Innovation Officer,

Navitas Clinical Research

The clinical research landscape is continuously evolving. We see more and more decentralized trials with virtual, remote and hybrid trial methods with increased data variety including real world data (RWD) and real world evidence (RWE), genetic data, genomic data, wearables. Data may be collected through clinical and healthcare Apps, tele-visit software, directly from the patient, and from lab vendors, imaging centers, genetic testing and biomarker applications. Many studies include data directly from EHR/EMR systems.

Modern clinical data flow and technologies must support the implementation of emerging data strategies and enable the aggregation, integration, and interpretation of high volumes of data, continually generated from many sources and multiple systems with complex data structures. A powerful e-Solution platform needs to provide immediate access all of its data assets, support metadata driven data harmonization and integration, facilitate risk-based monitoring, quality management, medical data review, data reporting and visualization, and submission in one convenient location. The system needs to be flexible regarding the types of data which can be harmonized and mapped. Additionally, the system should accommodate change since it is not possible to anticipate future data sources or elements that may be relevant to clinical research.

What are some of the challenges or barriers that exist in achieving efficient clinical data harmonization and system interoperability?

Lack of data standards and controlled terminology presents problems when trying to aggregate data from health and research data or carry out meta-analyses. It often limits the ability to utilize data from two different resources focused on the same therapeutic area and intervention. This lack of compatibility wastes resources and prevents the timely evaluation of treatment efficacy, safety and care management.

Lack of system integration is also an issue. When systems are not designed to manage the exponential growth in data sources and streams, workflows can become unwieldy, leading to increased potential of errors and prolonged timelines.

The increased complexity with data harmonization and system interoperability can be complicated and requires careful consideration, planning and implementation.

How does Navitas Life Sciences address clinical data harmonization and system interoperability? Are there any unique strategies employed?

The modern clinical studies collect and aggregate data from disparate sources, harmonize that data through an ontology, and facilitate pattern recognition to address clinical research, health care and scientific needs. Exchanging research and health data with consistent language, content structure, and in a secure manner is critical to interoperability. For more than 30 years, the Navitas Life Science team has been developing disease specific common data elements and standards, eSolutions and digital systems for a diverse set of stakeholders. Our clients include the NIH institutes, DoD, FDA, large national and international networks, pharmaceutical and biotech companies. Beyond building data systems, our teams are experts at connecting public and private data to further research, science, health management and interoperability goals. We understand the complexities of incorporating clinical research and patient information from multiple sources while providing the tools and functionality to conduct data analysis, support critical decision-making at the disease specific population level, implement governance policies and comply with regulations.

ThoughtSphere

ThoughtSphere, founded by passionate leaders and life science IT experts, understands the needs of customers and works everyday to develop innovation solutions to propel clinical research.

ThoughtSphere’s stacked platform delivers a streamlined & simplified solution for executing clinical trials by using AI to integrate and automate processes from data aggregation to the generation of validation-ready datasets.

Christina Dinger,

Senior Director of Product,

ThoughtSphere

The need for greater data interoperability is only going to grow. The days of clinical operation data and departmental silos are coming to an end. Life Science organizations are undergoing a digital transformation which is rooted in the ability to bring together data, people, and processes through system interoperability in an efficient and scalable way. Organizations within the industry will continue to move from relational databases to non-relational databases due to the vast array of data sources and the ever-growing amount of real-time, metadata-rich data needed to conduct modern clinical trials. Additionally, the use of ML and AI models will become the new standard to supporting system interoperability and the automation of data review processes.

How does ThoughtSphere support access to a variety of complex source system data in near real-time?

ThoughtSphere's patented data aggregation and harmonization solution automates much of the work required to acquire, ingest, aggregate, and harmonize clinical and operational data from various data sources. Out-of-the-box adapters to support data ingestion from Medidata Rave, Veeva CTMS, Oracle Argus and several others are available. Data calls to SFTP/File Stores can also be easily set-up in the system. The inbuilt scheduler allows users to schedule full data loads or delta loads that automatically run per the frequency defined. The data processor has the ability to load both system audit data and cumulative data files (delimited or SAS data sets etc.) and store them in the data lake in their native, metadata-rich format.

Tell us more about the live demo during the webinar and will it showcase practical examples of how clinical data interoperability can be implemented in real-world scenarios?

We will show how system interoperability can be dramatically simplified through AI, and auto-data ingestion capabilities that eliminate upfront effort to extract, transform, and load data that is required for relational databases. We will also show examples of how unified and harmonized data can accelerate study planning and development through Smart Check recommendations as well as streamline data operational tasks that traditionally required manual processes to complete, such as cross-log form safety reviews, 3rd Party Vendor Reconciliation, and cross-functional data cleaning and patient tracking.

What can the audience expect at the webinar?

The webinar will be informative and engaging with a Q&A session at the end. We will provide attendees with a glimpse at some of the efficiencies, enhancements, and opportunities brought forth through an integrated platform. Additionally, we will provide a real case study for how Navitas used the platform to provide robust central monitoring capabilities and deliver higher quality data to their customers.

To learn more about our services and solutions, reach out to us at This email address is being protected from spambots. You need JavaScript enabled to view it.