Illustrative use case · Biotech planning & cash runway

When the trial timeline changes: Connect study plans, program costs and cash runway

A revised enrollment curve should not trigger another week of spreadsheet reconstruction. Explore how connected planning could help Finance and Clinical Operations see the cost and cash implications of a program change—and compare the options before the next board review.

Hypothetical enterprise scenario. Figures and targets illustrate the approach; they are not reported client results.

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Clinical study milestones connected to a financial planning model and three cash forecast scenarios
1
Study for the pilot
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Scenarios to compare
24
Month planning horizon
1
Approved assumption set
01 / The Business Decision.Start with the work your teams recognize.
01

Clinical plans move. The financial view struggles to catch up.

Consider a clinical-stage biotech with two active programs and outsourced trial delivery. One study faces slower enrollment and a revised CRO schedule. The CFO needs an updated funding view; Clinical Operations needs a plan it recognizes. Start with that study and its contribution to a 24-month company cash forecast, using aggregate operational data.

Enrollment changes outside the forecast

Site activation dates and recruitment assumptions are updated in study trackers while Finance still uses the previous milestone calendar.

Assign owners and effective dates to the drivers that change the financial forecast.

Spend and cash tell different stories

Activity may have occurred before an invoice arrives; a contract may commit future work without making payment due now.

Keep incurred cost, accruals, commitments, invoices and payment timing distinct.

Vendor estimates arrive in different formats

CRO, laboratory and site updates describe scope and timing differently. Finance cannot tell whether a revised estimate replaces or adds to the previous one.

Version estimates and map each cost line to the contract, activity and payment assumption.

Runway changes are hard to explain

A delay can defer a milestone payment while extending fixed costs. A simple shift of the entire budget hides both effects.

Model timing-driven and activity-driven costs separately, then connect the study to company cash.

One program changeSeparate cost from cashAn explainable funding view

The decision is not simply whether a trial costs more. Leadership needs to see which costs move, which increase, when payments fall due and how the change affects the agreed minimum cash threshold. Clinical and financial owners must approve the assumptions together.

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02 / A Controlled Approach.Connect inputs, checks and accountable decisions.
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Five steps from a revised study plan to a reviewed cash scenario

For this scenario, Grandview would connect approved operational drivers to a planning model and reconcile its outputs with Finance. The model supports management decisions; it does not predict clinical outcomes or replace the systems responsible for study records.

01

Map the study and financial baseline

Identify milestones, sites, enrollment assumptions, CRO estimates, contracts, actuals and cash inputs. Establish who can approve each change.

Output · Driver inventory & owners
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Separate activity, expense and payment

Map fixed monthly costs, activity-based costs and milestone payments. Define accrual and payment rules with Finance and avoid counting invoiced amounts twice.

Output · Cost & cash timing rules
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Connect and version the inputs

Load aggregate source updates with dates and reconciliation checks. Preserve the previous approved forecast alongside the working version.

Output · Versioned planning baseline
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Compare the decision scenarios

Model the base plan, a delay and a feasible operational alternative. Hold unrelated assumptions constant and show both cost and cash effects.

Output · Scenario comparison & driver bridge
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Review and publish the forecast

Clinical Operations reviews timing; Finance reviews cost, accruals and cash. Publish the approved version with an assumption-change record.

Output · Signed forecast & refresh responsibilities

Example: a delay does not move every cost in the same way

Illustrative assumption: a three-month extension adds $200,000 per month of trial-management cost, or $600,000 in total. A separate $1.2M milestone payment moves from month 6 to month 9. The payment shift changes timing; it is not a $1.2M saving.

Acceptance: the delayed scenario adds the extension cost once, moves the milestone payment once and leaves completed work intact. Finance checks accruals and invoices separately. Company runway also includes other programs, overhead, opening cash and explicit funding assumptions.

03 / Connected Architecture.Preserve ownership. Make the flow explainable.
03

Keep the systems. Connect the decision.

A bounded architecture for this scenario. Choose interfaces, refresh cadence and deployment after reviewing the existing environment.

LAYER 01

Keep specialist systems authoritative

Clinical systems hold operational records; ERP and contracts hold financial evidence. Use agreed aggregate study updates without making patient-level data a prerequisite.

Study milestones · CRO estimates · ERP
LAYER 02

Connect drivers to planning logic

Planning Analytics can hold study, scenario and time dimensions. Implement agreed activity, fixed-cost, accrual and payment rules and reconcile the inputs.

Planning Analytics · driver mappings · versions
LAYER 03

Review cost, cash and decisions together

Show estimate at completion, monthly payments and company runway separately. Compare assumptions, flag missing updates and publish an approved management view.

Scenario review · cash bridge · owner sign-off
04 / Illustrative Targets.Baseline. Target. Acceptance criteria.
04

Define the improvement. Agree how to measure it.

Illustrative baselines and targets for a bounded pilot. Confirm the starting point and acceptance criteria with your team before delivery.

Reforecast turnaround

BaselineTarget

Spend less time rebuilding a scenario

Illustrative baseline: five working days between a complete approved study update and a review-ready financial scenario.

Illustrative target: one working day for the same scope, an 80% shorter elapsed cycle. Track source delays and approval time separately.

Cost and cash visibility

BaselineTarget

Understand both amount and timing

Baseline: one budget curve is used as a proxy for expense and payments, concealing accruals and committed work.

Target: reconcile incurred cost, remaining forecast, commitments and payment schedule without double counting. Explain each material change.

Company runway

BaselineTarget

Trace the funding view to its assumptions

Baseline: runway is updated manually using average burn, masking milestone payments and program changes.

Target: calculate the first month cash falls below the agreed threshold using the monthly company forecast. Keep uncommitted financing as a separate scenario.

Forecast ownership

BaselineTarget

Publish a version both teams recognize

Baseline: study trackers and Finance workbooks contain different dates and vendor estimates.

Target: each material driver has an owner, timestamp and approval status. Preserve an audit trail from program change to forecast revision.

Start with one decision, establish the baseline and agree what a useful first release must prove.

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05 / Decision FAQs.Clear scope. Explicit assumptions. Practical next steps.
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Questions to settle before the first scope

Practical answers for the business owner, Finance and the team responsible for delivery.

Do we need to replace our clinical systems?

No. The proposed scope connects approved aggregate planning inputs with financial data. Specialist systems remain responsible for operational records. Decide supported interfaces and update cadence during assessment.

Do we need patient-level data?

This planning scope can begin with aggregate enrollment, milestone, site and vendor information. Define minimum required fields and access controls before integration; do not collect patient data simply because it is available.

Does slower enrollment always shorten runway?

No. Some payments may move later while fixed costs continue for longer. The net effect depends on contract terms, other programs and company cash flows. Model those effects explicitly rather than applying a blanket percentage.

How do you avoid counting invoices and accruals twice?

Finance defines the reconciliation between incurred activity, invoiced amounts and remaining accruals. Commitments and forecast-to-complete are also distinguished. Test representative cases and map reversals and adjustments before release.

What does the runway calculation include?

Opening cash plus forecast inflows less monthly payments across the company, compared with an agreed minimum cash threshold. Document FX, payment terms and funding assumptions. A study budget alone cannot establish company runway.

What does the first engagement cover?

Scope one study, a small set of cost drivers and its connection to the company cash forecast. Agree input availability, integration effort, owners and deliverables before setting a timeline. Expand only after the pilot reconciles.

Who approves the model and its scenarios?

Clinical Operations owns study timing and operating assumptions; Finance owns financial treatment and the cash forecast. IT supports access and interfaces. Leadership owns program and funding decisions.

Can the model recommend clinical or financing decisions?

The proposed workflow compares financial implications of approved assumptions. It does not establish clinical feasibility or make funding decisions. Qualified program owners and leadership review the scenarios and choose the next action.

06 / Your Next Step.Bring one challenge. Define a useful first scope.
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BRING YOUR PLANNING CHALLENGE

Tell us which study change is hardest to translate into cost and cash. Grandview brings planning, data and integration expertise to help your teams explore the options.

Talk to our team
Rochelyn Sy
Rochelyn SyPrincipal Consultant
IBM Gold Business PartnerPlanning, analytics & IBM expertise