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How integrated clinical, regulatory, pharmacovigilance and data science ecosystems are accelerating global development programs Insights ahead of the 2026 DIA China Annual Meeting Global drug development is becoming increasingly complex and sponsors need to manage changing regulatory requirements, decentralized trial models, increasing operational ...
Selecting the right clinical research organization (CRO) can determine the success or failure of a biotech company’s clinical program. With increasing complexity in clinical trials, regulatory demands and cost pressures, choosing the right CRO partner is more critical than ever. Yet many biotech companies continue to make avoidable mistakes ...
The conversation around R programming has fundamentally changed. What was once viewed as a niche statistical language, largely confined to academia, has steadily grown into a strategic capability for data-driven organizations, particularly in high-stakes, data-intensive industries such as clinical research, pharmaceuticals and biotech. Yet, despite...
SAHPRA Application ID Update 2025: Impact on eCTD Submission and eCTD Publishing The South African Health Products Regulatory Authority (SAHPRA) released an important communication (Issue No.: HPA16-2025/26) introducing a standardized Application ID system that directly impacts eCTD submission, dossier structuring, and eCTD publishing workflows. Th...
In 2001, a small group of life sciences leaders came together with a simple but unconventional idea, to create a space where industry peers could collaborate, benchmark and solve shared challenges. At the time, pharmacovigilance and regulatory environments were fragmented, largely manual and defined by siloed decision-making. Structured, peer-to-pe...
Real-world evidence (RWE) is emerging as a cornerstone of modern clinical development and regulatory strategy for patient-centric innovation. How is real-world evidence transforming clinical trials in Asia-Pacific? In her latest article published in PharmaFocus Asia, Yun Lu, Chief Science and Innovation Officer at Navitas Life Sciences, explores th...
Navitas has been awarded the EcoVadis Bronze Medal for the second consecutive year, showcasing the organization’s commitment to Environmental, Social and Governance (ESG) principles and responsible business practices. What is the EcoVadis Bronze Medal? EcoVadis is one of the world’s most recognized sustainability assessment platforms,...
Understanding Commission Implementing Regulation (EU) 2025/1466 and Pharmacovigilance in 2026 and Beyond Commission Implementing Regulation (EU) 2025/1466, adopted on 22 July 2025 and implemented on 12 February 2026, marks one of the most significant updates to EU pharmacovigilance (PV) practice since the introduction of Implementing Regulation (EU...
PHUSE APAC Connect 2026 brought together clinical data leaders, programmers and statisticians from across the region, and Navitas Life Sciences was proud to be part of the conversation. (from left to right) – Sheikh Ibrahim, Pradip Sivaramakrishnan, Swapnil Udasi, Neeraj Malhotra, Anbarasan Durairajan , RamMohan Konda, Rahul Somavanshi. --> W...
What Is Data Management in Clinical Trials? Data management in clinical trials is the structured process of collecting, validating, cleaning, standardizing and preparing clinical trial data for statistical analysis and regulatory submission. How does data management work in clinical trials? In simple terms, clinical data management ensures that tri...