Data Sciences in Pharma

Insights from the PHUSE Chennai SDE

Navitas Life Sciences was proud to be part of the highly attended PHUSE India SDE in Chennai, sharing our expertise in biostatistics, data sciences, and regulatory submissions. We were recognized as a Major Contender in the Everest Group Clinical Data Management Operations PEAK Matrix® Assessment 2025, which highlights our expertise in combining clinical data management with technology and therapeutic expertise.

Continuing with our thought leadership, we also recently published an article in PHUSE Global on Statistical Strategies for Quality by Design under ICH E6(R3).

188 professionals gathered in Chennai, India, marking the highest attended Single Day Event (SDE) held at this location. Hosted by ACL Digital, the event theme was “Achieving Successful Regulatory Submissions – Lessons Learnt and Best Practices”. As a silver sponsor, Navitas Life Sciences was proud to contribute thought leadership, best practices, and actionable insights across biostatistics, statistical programming, cybersecurity, and clinical data management solutions.

The event was opened by Shrishaila Patil K., Senior Vice President – Statistical Programming at Navitas Life Sciences, who also serves as PHUSE India Events Lead and PHUSE APAC Connect Co-Chair (2026). Shrishaila emphasized PHUSE’s role as a hub for collaboration, innovation, and knowledge-sharing in clinical data sciences. Shrishaila is also a CDISC Volunteer and has authored a book on “FDA Clinical Outcome Assessments and CDISC QRS Supplements.” His leadership set the tone for a day of knowledge exchange and practical learning.

Cybersecurity in the Pharmaceutical Industry

One of the standout moments of PHUSE India SDE was the keynote session by S. Maharajan, Vice President of IT Infrastructure & Chief Information Security Officer (CISO), Navitas Life Sciences. His talk, “Cybersecurity in the Pharmaceutical Industry,” was widely praised by attendees for being both insightful and highly relevant, addressing a topic of growing concern in the clinical research community.

Maharajan began by contextualizing the current trends in the pharmaceutical industry, where digital transformation, AI/ML adoption, GenAI copilots, digital twins, and 3D-printed oral capsules are accelerating clinical development. With these advancements, however, come heightened risks—especially as organizations increasingly rely on cloud platforms, wearables, real-world evidence (RWE) sources, and automated systems.

His presentation broke down the key aspects of cybersecurity in clinical research:

Cybersecurity Fundamentals: Maharajan highlighted the need to protect systems, networks, and data from unauthorized access, ransomware, phishing, and supply chain threats. He emphasized safeguarding the confidentiality, integrity, and availability of clinical trial datasets.

Cybersecurity Risks in Biostatistics & RWE:

• Data Integrity: Unauthorized changes to clinical trial datasets can directly impact statistical outcomes and regulatory submissions.
• Access Control: Unchecked access to sensitive statistical tools (e.g., SAS, R) opens the door for misuse.
• Tools Security: Unpatched or misconfigured software introduces vulnerabilities.
• Data Aggregation Risks: Insecure APIs and third-party vendors create weak points in RWE pipelines.
• Patient Privacy: Even de-identified datasets carry re-identification risks, complicating compliance with GDPR and HIPAA.
• Cloud & AI Security: Misconfigured environments and poorly trained AI/ML models increase exposure.

Best Practices for a Resilient Cybersecurity Framework: Maharajan outlined a pragmatic roadmap, including:

• Zero Trust architecture for access control
• Embedding threat intelligence into monitoring systems
• Strengthening employee training and awareness programs
• Secure cloud adoption and encryption for sensitive health data
• Proactive vendor and supply chain risk assessments

The talk was interwoven with real-world case studies and practical examples, such as how AI-driven threat detection can mitigate evolving risks and how cybersecurity lapses can derail regulatory submissions and trial timelines.

The session drew significant engagement from the audience, with participants praising its clarity, practical recommendations, and future-focused insights. It was rated as one of the most impactful talks of the day, underscoring the importance of embedding cybersecurity strategies into every stage of biostatistics, data management, and RWE analytics.

Efficiency in Creating a Good-Quality Submission Package

Anbarasan delivered a technical session on building efficient and compliant CDISC Study Data Tabulation Model (SDTM) submission packages.

Drawing on over 15 years of statistical programming expertise, Anbarasan walked the audience through best practices in:

• Creating robust aCRF documentation with clear bookmarks and cross-links
• Validating datasets to ensure alignment with reviewer expectations and compliance with FDA/EMA submission standards
• Managing metadata consistency across MedDRA, WHO dictionaries, SDTM IG, and trial summary domains
• Performing dry-run validation with Pinnacle21 (P21) to ensure eSubmission readiness

His presentation highlighted the importance of standardized data structures for efficient regulatory review and demonstrated how Navitas Life Sciences’ statistical programming expertise accelerates compliant, submission-ready datasets that meet global regulatory standards.

A Day of Learning and Collaboration

The Chennai SDE was packed with 11 presentations and a lively panel discussion, reflecting the industry’s growing focus on data integrity, cybersecurity, submission readiness, and regulatory compliance. With active participation and highly rated sessions, it reinforced why PHUSE SDEs are such powerful forums for innovation and peer learning.

Navitas Life Sciences continues to shape the future of biostatistics and data management in clinical research, our presence at PHUSE India SDE reaffirms our commitment to building high-quality, secure and future-ready data strategies for global pharma and biotech.

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