Navitas Life Sciences’ Thought Leadership Articles

As a leading CRO, Navitas Life Sciences consistently drives innovation in clinical trials, including oncology research, data sciences, regulatory affairs and pharmacovigilance. Our thought leaders have published a series of impactful articles that address critical industry challenges and advancements, showcasing our expertise and commitment to improving patient outcomes worldwide.

Our latest blog provides a summary of insightful articles that underline our dedication to transforming clinical research and pharmacovigilance.

Challenges and Benefits of Implementing IDMP in the Pharmaceutical Industry

Publication: Pharmaceutical Commerce

Authors: R. Mallikarjunan, Mohammed Yaseen, and Prasana Santhuru

This article explores the complexities of implementing Identification of Medicinal Products (IDMP) standards, highlighting the benefits of improved regulatory compliance and data harmonization, while addressing challenges like resource allocation and system integration.

Current Status of Biosimilars and Their Impact on Pharmacovigilance

Publication: Pharma Exec

Authors: Dr. Philipp Hofmann

The article analyzes the evolving landscape of biosimilars, emphasizing their role in expanding patient access and the need for robust pharmacovigilance strategies to ensure safety and efficacy.

Best Practices for Clinical Registries While Leveraging Real-World Evidence

Publication: PLOS

Authors: Dr. Yun Lu, Sarah Lawrence, and Andra Matthews

This article outlines strategies for designing and managing clinical registries, demonstrating how real-world evidence can enhance clinical decision-making and regulatory approvals.

Automation of Literature Search and Review

Publication: Pharmaphorum

Authors: VSN Raju Datla, Shabana Banu Shaik, and Dr. Pushpa Basavanapalli

Discover how automation tools are revolutionizing literature searches, saving time, and improving accuracy in identifying relevant research for clinical trials and regulatory submissions.

Technology-Enabled Real-World Data and Clinical Research Data Integration in a Clinical Registry Ecosystem for Foundations

Publication: Applied Clinical Trials

Authors: Yun Lu, Sowmya Kaur, Susan Li, and Sarah

This article delves into the integration of real-world and clinical research data within registry ecosystems, showcasing innovative approaches to enhance data utility for nonprofit foundations.

De-Mystifying R Programming in Clinical Trials

Publication: Pharmaverse

Authors: Venkatesan Balu

Venkatesan Balu simplifies the complexities of R programming, demonstrating its potential to streamline data analysis and reporting in clinical trials.

The Crucial Role of Pharmacovigilance in Combatting Counterfeit Drugs

Publication: Pharmiweb

Authors: Dr. Philipp Hofmann

This piece highlights the importance of pharmacovigilance in detecting and mitigating the risks associated with counterfeit medications, ensuring patient safety.

GenAI in PV and Regulatory Affairs

Publication: PharmaFocusEurope

Authors: Marty Boom

Explore how generative AI (GenAI) is transforming pharmacovigilance and regulatory processes, driving efficiency and innovation.

Insights on the UK's MHRA International Recognition Procedure

Publication: Pharmacy Times

Authors: Mallikarjunan

Gain insights into the UK’s MHRA recognition procedures and their implications for global regulatory compliance in clinical research.

Exploring the Impact of Virtual Clinical Trials on Patient Care

Publication: PharmaFocus America

Authors: Sowmya Kaur

This article examines how virtual clinical trials enhance patient accessibility and reduce trial timelines, reshaping the future of clinical research.

Harnessing RWD/RWE for Clinical Insights

Publication: PharmaFocus America

Authors: Dr. Yun Lu

Dr. Yun Lu discusses how real-world data and evidence drive actionable clinical insights, enabling better decision-making and patient outcomes.

How Do Drug Shortages Affect Pharmacovigilance?

Publication: PharmaExec

Authors: Dr. Philipp Hofmann

This article addresses the impact of drug shortages on pharmacovigilance efforts, emphasizing the need for proactive risk management strategies.

Global Clinical Trials - Pitfalls, Challenges, and Future Perspectives

Publication: Pharmiweb

Authors: Malli A

Malli A provides a comprehensive overview of the challenges faced in global clinical trials and outlines strategies to navigate complex regulatory landscapes.

These articles underscore Navitas Life Sciences’ expertise in addressing the complexities of clinical trials, including oncology clinical trials and 20+ therapeutic areas, data sciences, regulatory affairs and pharmacovigilance. They reflect our relentless pursuit of excellence and commitment to advancing global healthcare.

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