The AI and Tech Decision Compass™ — The Decisions that Shape AI Value in Pharma & Biotech

Strategy & Prioritization — Set Direction

Opportunity Discovery: Map high-value AI opportunities across discovery, clinical development, manufacturing, and commercial. (Tech, Fin)
AI Strategy & Ambition: Define your AI ambition, guiding principles, and strategic choices across the R&D, medical, and commercial portfolio. (Fin, Tech)
AI Portfolio Prioritization: Choose which AI use cases to pursue across discovery, clinical, manufacturing, and commercial. (Fin, Tech)
Peer Benchmarking: Assess AI maturity, capabilities, and adoption against peers to spot gaps, risks, and opportunities. (Fin, Tech)

Governance, Risk & Regulatory — Stay Compliant

Global AI Regulations: Track and translate evolving FDA, EMA, and other global expectations for AI into a clear, actionable regulatory strategy. (Reg, Legal)
AI Governance & Ethics: Establish how AI decisions are made, overseen, and documented, including accountability, patient safety, bias, and fairness. (Reg, Legal, Tech)
Credibility & Documentation: Build risk-based model credibility, explainability, and documentation for regulators and internal bodies. (Reg, Tech)
GxP AI Validation: Validate GxP-relevant AI systems (e.g., manufacturing, clinical tools) in line with GAMP 5, ALCOA++, and other data integrity standards. (Reg, Tech)

AI Value & Performance — Prove Value

AI Business Case: Quantify projected costs, benefits, risks, and timelines to build robust business cases for AI investments. (Fin)
Value Realization & Metrics: Define and track value, ROI, and operational KPIs after deployment to confirm AI delivers as planned. (Fin, Tech)
AI Cost & Spend Optimization: Optimize compute, cloud, licensing, and model-run costs relative to realized value and risk. (Tech, Fin)
Model Lifecycle & Decommissioning: Monitor AI models and update or decommission them to meet quality and regulatory expectations. (Tech, Fin, Reg)

Technology & Partner Selection — Access Capabilities

Build, Buy, or Partner: Decide whether to build, buy, open-source, or partner for AI capabilities based on strategic value, risk, and time-to-impact. (Fin, Tech, Legal)
Vendor & Platform Selection: Assess vendors and platforms for technical fit, roadmap, compliance, information security, and total cost. (Tech, Legal)
CRO, CDMO & External Execution: Manage AI services delivered through CROs, CDMOs, and other ecosystem partnerships. (Legal, Fin)

Data & Technology Foundations — Build the Base

Data Governance & Integration: Build a high-quality, interoperable foundation for data flows across systems, partners, and regulators. (Legal, Tech)
Infrastructure, Cloud & MLOps: Provision and manage cloud, infrastructure, and MLOps to run, monitor, and retrain models reliably and safely. (Tech)
Security, Privacy & IP: Protect sensitive data and proprietary IP across workflows and partners, in line with HIPAA, GDPR, and trade-secret rules. (Tech, Legal)

Talent & Operating Model — Make It Stick

AI Operating Model: Design and implement an operating model for AI (hub, spoke, or hub-and-spoke) that maps onto how work actually gets done. (Talent, Tech)
AI Talent, Leadership & Culture: Hire and build specialist AI talent while building AI culture and fluency in leadership teams and the broader workforce. (Talent, Tech)
Change & Adoption: Promote AI-enabled ways of working in R&D, medical, safety, and commercial teams. (Talent, Tech)

Tags show where a decision needs specialist expertise on top of your domain expertise — few lean pharma or biotech teams hold all of it in-house. (Technology, Regulatory, Finance, Legal, Talent)

High cost of getting it wrong

Standing still means being left behind, but patient safety, GxP controls, and evidence expectations raise the cost of getting AI and tech decisions wrong.

Fragmented expertise

AI and tech decisions cut across strategy, regulatory, data and infrastructure, vendors, and change, but few teams hold that combination in-house.

How ResolveNext closes the gap

Our peer benchmarks, expert calls, and first-hand interviews allow leaders to make decisions guided by practitioner experience.

Get the Compass.

The compass identifies 21 decisions that organizations must make as they invest in AI and tech, along with a map of AI-emabled capabilities, and a list of KPIs. Contact us to get the full framework.

You can also email us directly

Your compass to navigate AI and technology decisions