The GenAI Revolution in Pharma—From Hype to Hard ROI in 120 Days

Situation

GenAI can accelerate writing, analysis, and knowledge discovery across R&D and operations—but only if it’s tied to specific business outcomes and guardrails.

Analysis

The fastest wins come from three streams:

1. Document Acceleration: protocols, CSRs, IBs, SOPs—use copilots to generate first drafts, redlines, and traceability matrices.
2. Clinical Ops Insight: automate patient‑visit summarization, query resolution suggestions, and risk‑based monitoring notes.
3. Quality & Compliance: change‑control summaries, deviation narratives, and audit‑readiness packs with human‑in‑the‑loop review.

Recommendation

Run a 120 Day GenAI Value Sprint:

• Day 0–15: use‑case triage (score by impact, feasibility, compliance).
• Day 16–45: pilots in two workstreams; define SOP addenda and record‑keeping.
• Day 46–90: scale the winning use case; add role‑based training and KPIs.
• Day 91–120: governance: bias testing, data retention, vendor checks, and audit trails.

Expected Impact

30–50% cycle‑time reductions on document workflows, cleaner inspection trails, and happier teams—without compromising GxP.

Ask for our GenAI Value Sprint Briefing—a 30‑minute overview with templates and risk controls.