Brief · Template

Plan.

LivePlan

Turn an objective into a sequence someone can start on Monday: milestones with exit criteria and one owner each, the clocks you do not control, what could derail it, and the first move with a date.

You getA plan of about 1,500 words (Standard) or 2,400 (Comprehensive)

LengthsStandard or Comprehensive

Written byOne AI specialist, chosen for the objective

SourcesEvery date and clock cited, or marked as a gap

Add it to your library to reuse from New → From template. Edit the saved copy in your library on the service form.

When to use it

You know the objective and the finish line, and you need the sequence of steps, owners and decisions that gets there.

Who it is for. Leads who have to deliver something with deadlines other people control: regulatory, clinical operations, market access, evidence, pharmacovigilance and partnership leads.

Why plans slip

Projects overrun by more than their average suggests. An analysis of 1,471 IT projects found an average cost overrun of 27 percent, but one in six had an average cost overrun of 200 percent and a schedule overrun of almost 70 percent. The plans that survive are the ones that name one owner per step, say what finishes each step, separate the clocks they control from the clocks they do not, and ask in advance how they could fail.^{4Flyvbjerg, B. and Budzier, A. Why Your IT Project May Be Riskier Than You Think. Harvard Business Review, September 2011.}

What you get

The objective, with its finish line. Five labeled lines: the objective, what finished looks like, the one accountable owner, the critical path and the contingency.^{3Rogers, P. and Blenko, M. Who Has the D? How Clear Decision Roles Enhance Organizational Performance. Harvard Business Review, January 2006. Bain and Company.}

The sequence, with exit criteria. Five to ten milestones, each with its exit criterion, its owner, its duration and whether it sits inside or outside your organization. A timeline is drawn only when at least three durations are sourced or marked as estimates.

Gates and decisions. At Comprehensive length, the points where someone decides to go on, stop, hold or recycle, with the criteria and a branch for the no-go.^{1Cooper, R. G. Stage-gate systems: a new tool for managing new products. Business Horizons, 1990;33(3):44–54. DOI 10.1016/0007-6813(90)90040-I.}

Who is needed. At Comprehensive length, a responsibility table with exactly one accountable person for each row.^{3Rogers, P. and Blenko, M. Who Has the D? How Clear Decision Roles Enhance Organizational Performance. Harvard Business Review, January 2006. Bain and Company.}

Dependencies and external clocks. What you do not control, and whether each delay is counted in calendar days or in the days an agency is actually reviewing. Agencies often count only their own time, so the two can differ by months.^{5U.S. Food and Drug Administration. MDUFA Performance Goals and Procedures, Fiscal Years 2023 Through 2027.}

What could derail it. A pre-mortem: three causes at Standard length, three to five plus a risk map at Comprehensive, each with a trigger, an owner, a mitigation and a start-by date.^{2Klein, G. Performing a Project Premortem. Harvard Business Review, September 2007.}

The first move. The closing section names the action, the owner, the date, and what it unlocks.

What is in it, by length

Section	Brief	Standard	Comprehensive
The objectiveThe objective, the finish line, the owner, the critical path and the contingency	–	●	●
The sequenceThe milestones, exit criteria, owners and durations	–	●	●
Gates and decisionsWhere someone decides, and on what criteria	–	–	●
Who is neededWho is responsible, accountable, consulted and informed	–	–	●
Dependencies and external clocksWhat you do not control, and how it is counted	–	●	●
What could derail itThe causes of failure, with triggers and mitigations	–	●	●
The first moveThe first action, its owner and date, and what it unlocks	–	●	●

A Standard plan reads in about 1,500 words. A Comprehensive plan reads in about five. Brief is not offered for a Plan.

Choosing a length

Choose Standard when one team runs the plan and the gates are few. Choose Comprehensive when several parties are involved, decisions have to be taken along the way, or a delay in one step would move the finish.

The standards and practice behind it

The structure and the checks come from published practice in stage-gate management, decision roles, pre-mortems and project risk. These are the references we drew on and what we took from each. None of their authors has reviewed the template.

What we took	From	Where it shows
Divide the work into stages separated by gates, where deliverables are judged against stated criteria	Stage-gate systems for managing new products (Robert Cooper)^{1Cooper, R. G. Stage-gate systems: a new tool for managing new products. Business Horizons, 1990;33(3):44–54. DOI 10.1016/0007-6813(90)90040-I.}	Gates and decisions, and the exit criterion on each milestone
Imagine the plan has failed and explain why, while there is still time to change it	The project premortem (Gary Klein)^{2Klein, G. Performing a Project Premortem. Harvard Business Review, September 2007.}	What could derail it: causes, triggers, owners and start-by dates
Name who recommends, who must agree, who performs and who decides	RAPID decision roles (Rogers and Blenko, Bain and Company)^{3Rogers, P. and Blenko, M. Who Has the D? How Clear Decision Roles Enhance Organizational Performance. Harvard Business Review, January 2006. Bain and Company.}	One accountable owner for the plan and for each row of the responsibility table
Correct for optimism: a plan should carry contingency in proportion to how often projects like it overrun	Why Your IT Project May Be Riskier Than You Think (Flyvbjerg and Budzier, Harvard Business Review, 2011)^{4Flyvbjerg, B. and Budzier, A. Why Your IT Project May Be Riskier Than You Think. Harvard Business Review, September 2011.}	The contingency line in the objective and the risk map at Comprehensive length
State whose days are counted when a clock is outside your control	MDUFA performance goals and procedures, fiscal years 2023 to 2027 (FDA), as an example of an agency counting its own review days^{5U.S. Food and Drug Administration. MDUFA Performance Goals and Procedures, Fiscal Years 2023 Through 2027.}	The dependencies section says whether a delay is in calendar days or agency review days

What it will not do

It does not guarantee the dates. The durations are sourced or marked as estimates, and the plan says which.

It does not invent an agency’s deadlines. A deadline that is not published is a gap.

It does not run the plan. It gives an owner the first move and the criteria for the next gate.

References

[1] Cooper, R. G. Stage-gate systems: a new tool for managing new products. Business Horizons, 1990;33(3):44–54. DOI 10.1016/0007-6813(90)90040-I. Catalog record; the description of gates is from secondary summaries and the article was not read.
[2] Klein, G. Performing a Project Premortem. Harvard Business Review, September 2007.
[3] Rogers, P. and Blenko, M. Who Has the D? How Clear Decision Roles Enhance Organizational Performance. Harvard Business Review, January 2006. Bain and Company.
[4] Flyvbjerg, B. and Budzier, A. Why Your IT Project May Be Riskier Than You Think. Harvard Business Review, September 2011. Figures as given in the abstract and summaries of the article: 1,471 projects, average cost overrun 27 percent, one in six a “black swan”. A later dataset of more than 5,400 projects exists.
[5] U.S. Food and Drug Administration. MDUFA Performance Goals and Procedures, Fiscal Years 2023 Through 2027. Read on 9 October 2026: goals expressed in FDA days and calendar days, as cited in the SaMD use case.

Links checked 9 October 2026

These are the sources the template drew on. None of their authors or issuers has reviewed it.

About the Brief service

A Brief is a written answer from one specialist, at the depth you asked for. It arrives with its sources, and it closes by saying plainly what would change the conclusion. Nothing is hidden behind a summary, and anything the expert could not source is marked as a gap rather than filled in.

Use cases for the Plan

9 ready-to-run use cases. Each opens its own page with the question, the specialists, the standards and the references.

CRLiveConsultation Response PlanPlan a response to a regulatory consultation: what it asks, where the decision points are, who is needed and what could derail it.PlanPublic Affairs

Open Open →

SSLiveSaMD Submission PlanPlan the FDA submission and pivotal evidence for an AI diabetic retinopathy device, with the external clocks and the first move.PlanRegulatory

Open Open →

TELiveTrial Enrollment Recovery PlanPlan the recovery of a Phase 3 trial behind on enrollment: milestones, owners, outside dependencies and the first move.PlanClinical Operations

Open Open →

EMLiveEU Market Access PlanPlan the path from HTA submission to the first reimbursed patient in one European market, with the external clocks and gates.PlanMarket Access

Open Open →

RELiveReal-World Evidence Study PlanPlan a real-world evidence study for payer negotiations, from protocol to report, with the data access and approval clocks.PlanMarket Access

Open Open →

SMLiveSignal Management Setup PlanPlan the setup of a safety signal management process before authorization, with owners, dependencies and the first move.PlanPharmacovigilance

Open Open →

PLLivePartnership Launch PlanPlan the first year of a commercialization partnership, from term sheet to the first joint launch activity, with gates and owners.PlanCorporate Development

Open Open →

LELiveLegislative Engagement PlanPlan engagement on a legislative proposal from now to the committee vote: the touchpoints by stage, the owners, the ask, the disclosure steps and what could derail it.PlanPublic Affairs

Open Open →

PRLiveProposed Rule Comment PlanPlan a comment on a proposed federal rule: what the notice proposes, the owner, what a strong comment covers, the clock the notice states and the disclosure question.PlanPublic Affairs

Open Open →

To edit a saved template, open New → Brief → From template, or the library rail on the service form.

When to use it

You know the objective and the finish line, and you need the sequence of steps, owners and decisions that gets there.

Who it is for. Leads who have to deliver something with deadlines other people control: regulatory, clinical operations, market access, evidence, pharmacovigilance and partnership leads.

Why plans slip

What you get

The first move. The closing section names the action, the owner, the date, and what it unlocks.

What is in it, by length

Section	Brief	Standard	Comprehensive
The objectiveThe objective, the finish line, the owner, the critical path and the contingency	–	●	●
The sequenceThe milestones, exit criteria, owners and durations	–	●	●
Gates and decisionsWhere someone decides, and on what criteria	–	–	●
Who is neededWho is responsible, accountable, consulted and informed	–	–	●
Dependencies and external clocksWhat you do not control, and how it is counted	–	●	●
What could derail itThe causes of failure, with triggers and mitigations	–	●	●
The first moveThe first action, its owner and date, and what it unlocks	–	●	●

A Standard plan reads in about 1,500 words. A Comprehensive plan reads in about five. Brief is not offered for a Plan.

The standards and practice behind it

What we took	From	Where it shows
Divide the work into stages separated by gates, where deliverables are judged against stated criteria	Stage-gate systems for managing new products (Robert Cooper)^{1Cooper, R. G. Stage-gate systems: a new tool for managing new products. Business Horizons, 1990;33(3):44–54. DOI 10.1016/0007-6813(90)90040-I.}	Gates and decisions, and the exit criterion on each milestone
Imagine the plan has failed and explain why, while there is still time to change it	The project premortem (Gary Klein)^{2Klein, G. Performing a Project Premortem. Harvard Business Review, September 2007.}	What could derail it: causes, triggers, owners and start-by dates
Name who recommends, who must agree, who performs and who decides	RAPID decision roles (Rogers and Blenko, Bain and Company)^{3Rogers, P. and Blenko, M. Who Has the D? How Clear Decision Roles Enhance Organizational Performance. Harvard Business Review, January 2006. Bain and Company.}	One accountable owner for the plan and for each row of the responsibility table
Correct for optimism: a plan should carry contingency in proportion to how often projects like it overrun	Why Your IT Project May Be Riskier Than You Think (Flyvbjerg and Budzier, Harvard Business Review, 2011)^{4Flyvbjerg, B. and Budzier, A. Why Your IT Project May Be Riskier Than You Think. Harvard Business Review, September 2011.}	The contingency line in the objective and the risk map at Comprehensive length
State whose days are counted when a clock is outside your control	MDUFA performance goals and procedures, fiscal years 2023 to 2027 (FDA), as an example of an agency counting its own review days^{5U.S. Food and Drug Administration. MDUFA Performance Goals and Procedures, Fiscal Years 2023 Through 2027.}	The dependencies section says whether a delay is in calendar days or agency review days