Practical Life Science Playbooks for Clinical, Regulatory, and GxP Teams
Table of Contents
Regulatory Submission Planning Playbook (IND / NDA / BLA)
End-to-end Plan, Authoring Workflow, eCTD Assembly, Timelines, and Review Cycles.
FDA Meeting Strategy Playbook (Pre-IND, EOP2, Pre-NDA/BLA, Type C)
Objectives, Briefing Books, Q-list, Rehearsal, and Follow-up Commitments.
The Clinical Development Plan Playbook
Indication Strategy, Endpoints, Trial Sequencing, Assumptions, and Decision Gates.
Clinical Trial Start-Up Playbook (Country/Site Activation)
Feasibility → Site Selection → Contracts/Budgets → IRB/EC → First-patient-in.
The Protocol Design Playbook
Endpoint Selection, Inclusion/Exclusion Tradeoffs, Sample Size Logic, Operational Feasibility, and Risk Controls.
The Vendor & CRO Selection Playbook
RFP, Bid Grid, Scoring, Governance Model, KPIs, and Change-order Management.
TMF Setup & Inspection Readiness Playbook
TMF Taxonomy, Completeness Rules, QC Routines, and Mock Inspection Checklists.
The GCP Quality Management Playbook
QMS Basics for Clinical, Risk-based Monitoring, Deviations/CAPA Linkage, and Audit Program
Pharmacovigilance Operating Model Playbook
Case Intake/Processing, Safety Database Workflow, SOP Set, PV Agreements, and KPIs.
Signal Detection & Safety Governance Playbook
Signal Identification, Evaluation, Documentation, Committee Cadence, and Label-change Process.
CMC Strategy Playbook (Phase I → Commercial)
Critical Quality Attributes, Control Strategy, Comparability, and Readiness Milestones.
The Tech Transfer Playbook (Sponsor ↔ CDMO / Site-to-Site)
Transfer Package, Roles/RACI, Validation Batches, and “Handoff Criteria.”
GMP Readiness Playbook (for Emerging Biotech)
Build QMS, Batch Records, Training, Deviations/CAPA, and Pre-PAI Preparation.
Process Validation Playbook (PPQ)
Validation Plan, Sampling Strategy, Acceptance Criteria, and Continued Process Verification.
GxP Computer System Validation & Data Integrity Playbook
Validation Approach, Testing Packs, Part 11, ALCOA+ Controls, Audit Trail Reviews.
The EU MDR/IVDR Transition Playbook
Gap Assessment, Technical Documentation, Clinical Evaluation, PMS/PMCF, and NB Engagement Plan.
Medical Affairs Excellence Playbook
Operating Model, MSL Deployment, Insights-to-action Loop, and Compliant Content Use.
KOL Mapping & Engagement Playbook (Compliance-Safe)
KOL Segmentation, Engagement Plans, Fair-market-value Basics, and Documentation.
Launch Readiness Playbook (Specialty / Hospital / Rare Disease)
Cross-functional Workplan, Supply Readiness, Field Enablement, and Day 1 Metrics.
The HEOR / RWE Evidence Generation Playbook
Value Story, Study Roadmap, Endpoints, Data Sources, Publication Plan, and Payer-ready Outputs.
