Working Templates

Proven execution starting points, configured to the work.

PMO Performance converts industry-standard practices into detailed, ready-to-configure project plans, decision gates, and schedule-assurance tools for complex drug development and CDMO execution.

DRUG DEVELOPMENT PHASE · STAGE · GATE
Development phases
Discovery Research
Preclinical Development
Clinical Development
Review & Registration
Commercial Readiness
Commercial
Stages and decision gates
Target
Identification
G1
Target
Validation
G2
Lead
Discovery
G3
Lead
Optimization
G4
Preclinical
Development
G5
Phase I
G6
Phase II
G7
Phase III
G8
Review &
Registration
G9
Commercial
Readiness
G10
Commercial

Modality-Specific Execution

Drug Development Stage-Gate Project Plans

Small molecule, cell therapy, and gene therapy require materially different work. Each plan contains stage-level schedules with durations, estimated costs, department owners, dependencies, and objective Definitions of Done. Every decision gate includes a Go / No-Go checklist.

Small Molecule DevelopmentIllustrative template · configured to program strategy, evidence, and risk
Selected stage detail
Project schedule line itemDurationEstimated costDepartment ownerDependencyDefinition of DonePath

Gate checklist

Required evidence is reviewed before authorizing the next stage, revising the plan, or stopping further investment.

    Project Management Enablers

    The schedule is only valuable when it is executable.

    PMO Performance adds the construction standards, assessment discipline, and integrated lifecycle plans that expose risk early and improve the probability of successful delivery.

    I²nnovate Differentiator

    Project Schedule Line Item Assessment

    A structured assessment tests whether the plan is executable, measurable, and decision-ready. Current-state scoring is reconciled against explicit target requirements and accountable follow-through.

    Representative assessment criterionCurrentTarget
    Every task has an objective Definition of Done50%Yes
    Tasks are logically linked to predecessors and successors50%Yes
    Critical-path work has resource effort and ownership50%Yes
    Baseline, change control, and performance metrics are active50%Yes
    Project CharterRisk & IssuesChange ControlCommunicationSchedule RobustnessPerformance ManagementCommon Gaps
    CDMO Execution Backbone

    NPI PS: Order-to-Release Project Plan

    The CDMO Order-to-Release plan connects commercial commitment to technical execution and release across client milestones. This framework is now fully developed at CDMO Performance →, process development, engineering, GMP manufacturing, testing, documentation, and disposition.

    Contract & Kickoff
    Planning
    Process Development
    Tech Transfer
    Engineering Run
    GMP Readiness
    GMP Batch
    QC & Release
    Current / Baseline DatesDurationPredecessorsDepartment OwnerCritical PathRisk Log IDDefinition of DoneWork EffortMilestone ValueEarned Value
    Not a blank template.
    A tested execution starting point.

    Teams begin with industry-standard work, decision criteria, ownership, sequencing, and evidence expectations, then configure the plan to the product, client commitment, technical risk, and operating model. Lessons learned strengthen the next program instead of disappearing at closeout.

    Additional Template Library

    A common backbone, tailored by project type.

    Core PMO Templates

    • Project charter and business case
    • Integrated master schedule
    • RAID and decision logs
    • Communication and change plans
    • Benefits tracker

    Capital Project Templates

    • CAPEX pipeline and prioritization
    • Project four-panel
    • Spend, commitment, ETC, and EAC
    • Resource allocation model

    Product & Regulatory Templates

    • IND and filing readiness
    • CMC deliverables
    • Design controls and risk file
    • Verification and validation

    Manufacturing: CDMO / Tech Transfer

    • Order-to-Release plan
    • Proposal / SOW performance-to-plan
    • Readiness and release tracker
    • Client scorecard

    Manufacturing: External

    • External network lifecycle
    • Supply and quality readiness
    • Partner performance review
    • Risk and escalation cadence

    Review Charters

    • Core team and steering committee
    • Risk and readiness reviews
    • S&OP and monthly executive review