Learn. Apply. Improve.

Operational readiness for clinical data and programming teams

Build a readiness plan for your next milestone, or learn the methods behind it in a practical leadership handbook. Free, with no login, and your plans stay in your browser.

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Build a Readiness Plan

Assess milestones, dependencies, risks and required actions.

Open Navigator → Learn

Explore the Handbook

Learn methods, decisions and practical leadership examples.

Read Handbook →

Built for statistical programming, biostatistics, data management, regulatory and clinical teams. Read the guided walkthrough

Today's Readiness Brief · new every day at 10:00 ET

Five questions to ask on Sunday about any data milestone week

A ten-minute Sunday routine that tells you whether this week's lock, dry run or transfer is on track, and what to do first on Monday.

Week Ahead · Oct 18, 2026 · 3 min read

Read today's brief All briefs

Start from your situation

Which milestone is giving you trouble?

Each card opens the Navigator with the milestone and deliverable already chosen. You pick the accountable role and the target date.

01 · Database lock

Lock is approaching and key analysis decisions are still open.

Data readiness, population decisions, external data, dry-run findings, review and final controls.

Build this plan → 02 · Dry run / interim

You need the dry run to expose risk, not only prove code runs.

Define what the run must prove, prioritize high-risk outputs and triage findings.

Build this plan → 03 · Health authority request

A rapid regulatory request arrives with an ambiguous question.

Translate the request, confirm provenance and population, and preserve traceability.

Build this plan → 04 · Study startup

The timeline is defined but access, standards and ownership are not.

Operating model, access path, data and analysis map, and critical dependencies.

Build this plan → 05 · Late change

A late SAP, shell, population or derivation change arrives.

Impact analysis before implementation, regression scope and controlled closure.

Build this plan → 06 · Submission readiness

Datasets, metadata, guides and validation findings must converge.

Package inventory, metadata reconciliation, findings disposition and handoff.

Build this plan →

How the two fit together

The Handbook explains the decision. The Navigator makes it dated and owned.

01 · Read

Understand why and how to decide

Each chapter sets out the operational problem, a practical method, a worked example, failure modes and recommended actions.

02 · Apply

Turn it into a plan for your milestone

Every written chapter ends with a template and a link to the Navigator tool that applies the same logic. Workspace then tracks the actions on your device.

03 · Improve

Test it and tell us what is wrong

The Handbook chapters are author drafts. Review one against a synthetic scenario, or share a generalized lesson.

Handbook · Clinical Statistical Programming Operations

Three chapters written. Nine outlined, and labelled as such.

A practical leadership handbook for statistical programming leaders managing trials, teams, operational risk and submissions. The first three chapters are written in full; each links to a matching Navigator tool.

04Author draft

Resource and Capacity Planning

Compare demand with real capacity using ranges, independent QC and change triggers, and state the probability of meeting a date.

Tool: Capacity EstimatorRead chapter →

06Author draft

Dry Run and Database Lock Readiness

Four gates, latest acceptable dates and triaged findings, so open items are dispositioned before lock instead of during it.

Tool: Database-lock planRead chapter →

08Author draft

Dependency, Risk and Escalation Management

Write dependencies and risks someone can act on, and escalate with options and a deadline instead of alarm.

Tool: WorkspaceRead chapter →

See all 12 chapters Search the Handbook

Free, no login. Reading progress is kept on your device only.

Tools for the questions that come after the plan.

Analyze a changeA late change, data delay or authority request, mapped to affected work, owners and closure evidence.Open → Scenario simulatorDoes a moved lock or a lost programmer still fit? See what staffing can and cannot fix.Open → Capacity estimatorEffort as a range, calibrated on your own completed work.Open → Operational playbooksEight scenario response patterns: trigger, first actions, handoffs and evidence.Open → AI workflow builderDescribe a challenge in plain words and get a start-to-finish workflow. Ready-made offline workflows included.Open → Standards watchA reading list of authoritative FDA, CDISC and ICH sources, with local review status.Open →

Private by defaultPlans, notes and reading progress stay in your browser. No account, no paywall.

Honest about evidenceThe tools are expert-derived and not independently validated. Each page says what has and has not been reviewed.

Independent review invitedNo external review has been completed yet. Practitioners are invited to test the chapters and tools.

Generalized guidance onlyNever enter patient-level or sponsor-confidential data. This does not replace your SOPs, SAP or agency requirements.