Integrated Platform

Internal manufacturing performance tools, adapted for external manufacturing partnerships.

I²NNOVATE, The Actionable Insights, PMO Performance, and CMCDrugDevelopment were originally designed for internal manufacturing, CMC, and performance management needs. CDMO Performance leverages the relevant parts and adapts them for sponsor-side CDMO and CMO lifecycle management.

Platform Layers

One external manufacturing platform, built from proven capability layers.

I²NNOVATE

Operating model layer that connects strategy, people, process, systems, performance, and leadership cadence.

  • Strategy deployment
  • Leadership routines
  • Accountability
  • Continuous improvement culture

The Actionable Insights

Performance intelligence layer that turns KPI data into dashboards, scorecards, trends, and recovery decisions.

  • KPI architecture
  • Power BI dashboards
  • Weighted indices
  • Insight-to-action workflows

PMO Performance

Execution governance layer for stage gates, schedules, RAID, decisions, milestones, and recovery-to-plan.

  • Stage gates
  • Integrated schedules
  • RAID governance
  • Recovery planning

CMCDrugDevelopment

CMC and technical readiness layer for tech transfer, analytical transfer, validation, regulatory readiness, and lifecycle context.

  • QTPP/CQA/CPP alignment
  • Process transfer
  • Analytical transfer
  • Validation readiness

CDMO Performance

External manufacturing management layer that adapts the ecosystem to CDMO/CMO partner governance and patient-first performance.

  • CDMO scorecards
  • External manufacturing WPI
  • Partner governance
  • Lifecycle improvement

Guidebook and Toolkit

The implementation layer that translates the framework into templates, checklists, review charters, and scorecard definitions.

  • Gate checklists
  • KPI definitions
  • Review charters
  • Readiness templates

How It Fits

CDMO Performance is the external manufacturing application of the broader system.

CapabilityInternal Manufacturing UseExternal Manufacturing Adaptation
Leadership cadenceTier meetings, functional reviews, escalation routines.Sponsor/CDMO governance, joint steering committee, partner escalation.
Performance intelligenceSite dashboards, WPI, KPI thresholds, recovery actions.CDMO PSQDC scorecards, sponsor WPI, partner comparison, 24/7 visibility.
Execution governanceInternal project schedules, stage gates, resource planning.External tech transfer, readiness reviews, campaign governance, release planning.
CMC readinessProduct/process/analytical development and validation readiness.CDMO transfer package, method transfer, validation readiness, filing support.
Continuous improvementSite Lean Six Sigma, standard work, cycle-time and quality improvement.Joint improvement roadmap, partner development, scorecard recovery, lifecycle optimization.