Navitas Life Sciences’ Clinical Data Services: Showcasing at CPHI India 2023

Navitas Life Sciences boasts extensive experience in Clinical Data Services, covering a spectrum of crucial aspects including Data Management, Biostatistics & Programming, Data Standardization, Medical Writing, and Submissions. We are dedicated to delivering high-quality clinical trial data management while adhering to rigorous regulatory standards.

Domain Expertise: Our Pillar of Strength our Customers Rely on

Navitas Life Sciences stands out for its deep domain expertise in the management of data in clinical trials, cultivated over decades of collaboration with leading pharmaceutical and biotech companies. Our teams include highly qualified data managers and programmers, many of whom are Subject Matter Experts (SMEs) with years of experience in the industry. This wealth of knowledge ensures that your clinical data receives the attention it deserves, from inception to closure.

A Track Record of Excellence

Navitas Life Sciences has earned its reputation as a Major Contender in Everest Group’s Clinical Development Platforms Products PEAK Matrix® Assessment 2022. With an impressive track record in pharma clinical data science, including 670,000 pages of data entry, 21,000 unique Case Report Forms (CRFs) designed, and 62,000 edit checks, Navitas Life Sciences has demonstrated its ability to handle immense volumes of clinical data with precision.

Showcasing at CPHI and PMEC INDIA 2023

Navitas Life Sciences are pleased to be attending the upcoming CPHI and PMEC India event taking place in Delhi-NCR between 28th to 30th November. We met with our Associate Director of Global Data Sciences, Venkatesan Balu and our Senior Principal Biostatistician, Rajeshkumar Gajendran, both of whom will be present at CPHI India, to understand more about our solutions.

Venkatesan Balu

Associate Director of Global Data Sciences

Please provide examples of how Navitas has successfully supported clients in optimizing their Clinical Data.

Navitas Life Sciences has a proven track record of successfully assisting clients in optimizing their clinical data through a range of services and strategies. To begin, Navitas Life Sciences has been highly successful in designing studies (conventional vs adaptive vs Bayesian) with an effective sample size for ideal success. Alongside this, Navitas Life Sciences excels in optimizing data collection processes, technology integration, and risk-based monitoring (RBM) through the utilization of advanced technologies and tools, including electronic data capture (EDC) systems and AI-driven analytics. This results in streamlined data collection, data standardization, and analysis processes.

The use of advanced analytics and reporting tools enables Navitas Life Sciences to derive meaningful insights from collected data, facilitating informed decision-making and optimizing overall clinical trial processes. The implementation of optimized and streamlined clinical trial workflows enhances efficiency, reduces redundancies, and expedites the trial process.

Our success propels us along the path of continuous improvement, fostering a culture where feedback and learnings from each project are utilized to refine processes and enhance the quality and efficiency of data optimization strategies. Navitas Life Sciences leverages these strategies to provide comprehensive support to clients, aiming to optimize the quality, reliability, and efficiency of clinical data management in their trials.

What innovative approaches or technologies does Navitas use to handle and analyze large volumes of clinical data?

Adaptive Trial Design - We offer support in implementing adaptive trial designs, where data collected during the trial informs modifications to the study's parameters. This approach has proven instrumental in optimizing sample sizes, treatment arms, and data collection strategies, leading to more efficient trials.

Risk-Based Monitoring – Clients benefit from assistance in implementing risk-based monitoring strategies, which concentrate monitoring efforts on critical data points and high-risk areas. This approach proves more efficient than traditional on-site monitoring for all sites and all data.

Please share some insights on the challenges faced in biostatistics and data sciences in the current clinical research landscape.

Biostatistics and data sciences play a pivotal role in the design, analysis, and interpretation in clinical trial data management. In the current landscape, several challenges are encountered in these fields. Here are some insights into the challenges faced in biostatistics and data sciences in the context of clinical research.

The increasing demand for adaptive trial designs, allowing for modifications during the study based on interim results, is gaining popularity. However, implementing and interpreting adaptive designs require advanced statistical methodologies and careful planning, especially in the absence of regulated guidelines on the process.

Handling Missing Data: Addressing missing data and implementing appropriate imputation methods is a persistent challenge that can significantly impact the validity of study results.

What are some experts’ insights that you are looking forward to discussing at CPHI-Delhi?

• Adaptive Clinical Trials Utilizing Valid Statistical Methodology.
• Real-World Evidence (RWE) / Real-World Data (RWD) as an Extension of the Arm.
• Regulatory Compliance and Artificial Intelligence (AI).

Rajeshkumar Gajendran

Senior Principal Biostatistician

How does Navitas Life Sciences stay up-to-date with the evolving regulatory landscape in clinical data management?

Managing regulatory guidelines in biostatistics for clinical trials is a critical aspect of ensuring the validity, reliability, and ethical conduct of clinical research. Compliance with regulatory requirements is crucial to obtaining approvals from regulatory authorities and ensuring the safety and well-being of study participants. At Navitas Life Sciences, we conduct regular training programs for employees involved in statistical programming and clinical research, ensuring they are informed about the latest regulatory updates and compliance requirements.

Navitas Life Sciences also maintains well-established communication channels with regulatory authorities to seek clarification on guidelines, actively participates in workshops, and stay informed about upcoming changes. Importantly, we provide our employees with opportunities to join industry associations and forums related to clinical research and statistical programming. This allows them to network with peers, attend conferences, and access resources that provide insights into regulatory changes.

What are some key considerations for leveraging real-world data in clinical research, and how can Navitas Life Sciences assist in this area?

Harnessing real-world data (RWD) in clinical research provides invaluable insights into the safety, efficacy, and effectiveness of treatments in real-world settings. Navitas Life Sciences can be instrumental in this domain through various strategies. We specialize in developing robust data integration strategies to consolidate diverse datasets from various sources. Standardizing real-world data to enhance interoperability and comparability across different sources is a challenging task, and we actively contribute to the development of data standardization processes and methodologies.

Notably, we excel in developing and validating endpoints, ensuring alignment with study objectives and regulatory requirements. Navitas offers strategic consulting services to design and implement real-world evidence strategies that are precisely aligned with specific research objectives.

How does Navitas Life Sciences ensure patient data privacy in clinical trials?

Navitas Life Sciences ensures strict adherence to global data protection regulations, including the General Data Protection Regulation (GDPR) in Europe and the Health Insurance Portability and Accountability Act (HIPAA) in the United States. We employ techniques such as anonymization and pseudonymization to de-identify patient data, minimizing the risk of re-identification while still allowing for meaningful analysis.

Navitas Life Sciences implements secure channels for the transmission of data between various stakeholders involved in the clinical trial. Additionally, we employ secure and encrypted storage systems for both physical and electronic records.

What are the potential benefits of adopting advanced analytics and machine learning techniques in clinical data analysis, and how is Navitas leading in this space?

Embracing advanced analytics and machine learning techniques in clinical data analysis can yield numerous benefits, enhancing the efficiency, accuracy, and depth of insights derived from clinical trial data. At Navitas, we have identified the core implications of advanced analytics and ML techniques in the field of clinical trials.

Our advanced analytics algorithm facilitates the early detection of safety signals or adverse events by continuously monitoring and analyzing clinical data, thereby improving patient safety. Furthermore, our machine learning models can predict patient outcomes based on various factors, aiding in treatment planning and personalized medicine.

We excel in providing insights for optimal protocol design, contributing to the development of more efficient and cost-effective clinical trials through advanced analytics techniques.

CPHI and PMEC India 2023

Date: 28 – 30 November 2023

Venue: India Expo Centre, Greater Noida, Delhi-NCR

Navitas Life Sciences are pleased to be attending the upcoming CPHI and PMEC India event taking place in Delhi-NCR.

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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.