Navitas Life Sciences' Cutting-Edge Clinical Data Science for Efficient Clinical Trials

In today's data-driven world, the life sciences industry is experiencing advances that are increasingly complex, with the need to extract meaningful insights from vast amounts of clinical data. Navitas Life Sciences, a leading technology driven clinical trials partner, stands at the forefront of this revolution, offering comprehensive clinical data science services that drive innovation and reshape the landscape of risk-based monitoring.

In our latest blog we speak to Venkatesan Balu, Associate Director of Global Data Sciences, as he explores the data sciences support provided by Navitas Life Sciences, along with a deeper look at the article he authored and published in PHUSE titled “How Biostatisticians Use Advances in Technology to Reshape Risk-Based Monitoring.”

Venkatesan Balu

Associate Director - Global Data Sciences

What are the key advancements in technology that have had a significant impact on risk-based monitoring in clinical trials?

There have been several advancements in technology that have transformed risk-based monitoring in clinical trials. Automation, machine learning, and real-time analytics are among the key technological advancements that have enabled proactive identification of data anomalies, detection of outliers, and optimization of monitoring efforts to enhance patient safety and data integrity. Most importantly and interestingly acceptance of statistical implantation in this aspect adds an additional advantage to identify the early risks for the study.

How do data scientists at Navitas Life Sciences leverage advanced statistical methodologies to support clinical data management?

At Navitas Life Sciences, we leverage advanced statistical methodologies to employ the systems enable real-time data integration (OneClinical^® Analytics) to identify patterns, generate accurate reports, and identify potential risks and opportunities within data sets to enable speedy decision. Such data science in clinical research may be used to accurately optimize study design, site selection, design efficient monitoring strategies, and enhance patient safety and study efficiency.

FLEXIBLE AND INDUSTRY LEADING DATA MANAGEMENT SUPPORT

• Database & eCRF Design, Edit Checks, Programmed Dynamics, & UAT
• EDC Platform Development: InForm, Medidata RAVE, Veeva Vault, Medrio, & OpenClinica
• Programmed Standard & Smart Data Listings
• Data Quality, Data Cleaning, & Query Resolution
• SAE Reconciliation/External Data Reconciliation
• External Vendor & Project Team Management
• Document Creation including DVS, DMP & Data Entry Guidelines
• Audit Readiness & Study Documentation Management

Can you provide examples of how real-time monitoring and surveillance, driven by technologies like AI, have improved patient safety and regulatory compliance?

Real-time monitoring and surveillance, powered by technologies like AI have significantly improved patient safety and regulatory compliance. For example, our OneClinical^® Analytics provides near real time data, and by continuously analyzing data streams, these technologies enable early detection of adverse events, safety signals, and potential risks. This proactive approach allows for timely intervention and improved patient well-being. Furthermore, the automation and efficiency brought by these technologies enhance compliance with regulatory requirements, ensuring that clinical trials adhere to the highest standards.

What are the future trends and opportunities you foresee for data science in the life sciences industry?

The future is promising, with increased adoption of artificial intelligence and machine learning techniques for data analysis and decision-making processes. The collection of personal health data from wearables, and connected devices (ePRO) will provide opportunities for data scientists to generate valuable insights and drive personalized medicine.

Data privacy and integrity will enable the utilization of larger datasets while maintaining patient confidentiality. Overall, data science will continue to play a crucial role in accelerating drug development, optimizing healthcare outcomes, and improving patient lives.

Tell us more about your recent article published in PHUSE

In "How Biostatisticians Use Advances in Technology to Reshape Risk-Based Monitoring," the pivotal role of biostatisticians is highlighted in the emerging field of Risk-Based Monitoring (RBM). Experts leverage advancements in technology, such as automation, machine learning, and real-time analytics, to reshape traditional monitoring approaches.

In writing this article, I wanted to emphasize the impact of data science in enhancing patient safety, improving data integrity, and optimizing study efficiency, showcasing the invaluable contributions of biostatisticians in this critical domain.

How Biostatisticians Use advances in Technology to Reshape Risk Based Monitoring

The article sheds light on the role of Biostatisticians in the emerging field of Risk Based Monitoring. The increased frequency of offsite monitoring in clinical sites has resulted in a growing demand for the implementation of Risk-Based Monitoring (RBM) and Centralized Monitoring (CM). In order to establish a strong centralized monitoring team, it is essential to include biostatisticians and statistical programmers who may not have been traditionally involved in onsite monitoring but play crucial roles in ensuring robust monitoring processes.

Please read the article and get insights on

• Risk-Based Monitoring (onsite monitoring) and Centralized Monitoring
• The Need for Statisticians and Programmers
• How Statistical Interpretations for Risk Help Improve Efficiencies
• Using Statistical Analysis Responsibly

Read Now

Venkatesan Balu

Associate Director - Global Data Sciences

Navitas Life Sciences

Published by Phuse Global

June 2023

Navitas Life Sciences utilizes expert-driven Statistical Programming, Biostatistics, and Data Management services support for pharma clinical data sciences leading to successful clinical trial outcomes.

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