Novartis

Life Sciences • Top 20 Pharma • Priority: medium-high

Key Stakeholder Roles

VP Clinical OperationsHead of Digital TrialsR&D IT

DCT and RWE platform signals common across large sponsors.

Sources: FDA – Decentralized Clinical Trials Guidance

Relevant Signals

FDA RWE Guidance

Source

FDA guidance and submissions increasingly leverage Real-World Evidence (RWE) requiring platform/data modernization

Stakeholders: VP Clinical Development, Head of Data Science, Clinical Operations, Regulatory Affairs

GenAI Production Shift

Source

Enterprises shifting from pilots to production workloads, driving demand for governed AI platforms and data foundations

Stakeholders: CIO, CDO, VP AI/ML, Head of Platform Engineering

Decentralized Clinical Trials

Source

FDA guidance for decentralized clinical trials catalyzes software/data investments for DCT enablement

Stakeholders: VP Clinical Operations, Head of Digital Trials, CTO (R&D IT), Regulatory Affairs

FDA RWE Guidance

Source

RWE usage in submissions expanding; data/platform enhancements align with FDA guidance.

Stakeholders: VP Clinical Development, Head of Data Science, Regulatory Affairs

Decentralized Clinical Trials

Source

DCT enablement guidance implies need for patient apps, data integration, and compliant workflows.

Stakeholders: VP Clinical Operations, Head of Digital Trials, R&D IT

GenAI Governance & Compliance

Source

Enterprise AI programs entering Phase 2 production with increased scrutiny on model governance, lineage, and policy enforcement for 2026 scaling objectives.

Stakeholders: CIO, Chief Data Officer, VP AI/ML, Head of Compliance IT

Clinical Data Interoperability Mandates

Source

Rising pressure for real-time interoperability across eSource, eCOA, wearables, and EHR integrations to support adaptive trial designs.

Stakeholders: VP Clinical Systems, Head of Data Engineering (R&D), CTO (R&D IT), Regulatory Affairs

Related Opportunities

Gen AI Production Implementation Wave

Q1-Q2 2025

87% of enterprises moving from Gen AI pilots to production deployment. Current failure rate: 63% due to integration, governance, and talent gaps.

Urgency: Critical

Real-World Evidence Mandate Expansion

Q4 2024 - Q3 2025

FDA expanded RWE requirements for post-market surveillance and label expansions. Top 20 pharma companies must overhaul data infrastructure by end of 2025.

Urgency: Critical

Embedded Insurance Technology Partnerships

2025-2026

Traditional insurers partnering with retailers, automakers, fintechs to embed insurance into purchase flows. Technology integration (APIs, data sharing, underwriting automation) is primary barrier.

Urgency: Medium-High

Decentralized Clinical Trial Technology

2025-2027

35% of clinical trials will be decentralized by 2027 (up from 9% in 2023). Requires patient-facing apps, remote monitoring, data integration, regulatory compliance expertise.

Urgency: Medium-High

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