BA/BE acceleration · ROI model
You don't lose money on a failed BE study. You lose it on the four months you waited for a slot.
In-house BA/BE + development dossier under one roof means a first-time filing lands roughly four months sooner. Below is where that number comes from, and what it's worth on your molecule.V-26
Built for formulation, regulatory and business development leads.
Where the four months come from
Outsourced CRO
≈ 18 weeks (≈ 4 months) reclaimed on the critical path
See how we calculated this: the 5-step bridge
- 1CRO identification, RFP, quote comparison, MSA/contract execution3–6 wks0 (single contract)+0 wks
- 2Clinic slot queue / volunteer panel availability4–8 wksScheduled at kick-off+0 wks
- 3Bioanalytical method development + validationSequential, post-contractParallel to formulation & pilot batches+0 wks
- 4Protocol finalisation + EC submission cycle2 review rounds, external EC calendarDrafted with Module 2.7.1; EC dates pre-blocked+0 wks
- 5Sample analysis + CSR turnaround4–6 wks, sponsor queuePrioritised; CSR authored to CTD directly+0 wks
- ΣTotal critical-path saving+0 wks ≈ 4 months
If the pilot BE fails (industry-typical 20–30% for topicals, MR and high-variability drugs), the outsourced route restarts steps 1–2 (≈10–14 more weeks of re-contracting and re-queueing). In-house, it's a re-slot. That's why the saving used below is a P50 of ~4 months, not a ceiling: state it as a range, not a guarantee.
Calculator
What are those months worth on your molecule?
Five inputs drive it. Everything else (erosion curves, repeat-study risk, discount rate) is a defaults set you can open and edit.
Dollar figures throughout (this slider, and the CRO/in-house cost defaults under Advanced assumptions) are calibrated for USD-scale amounts. Adjust them manually after switching currency.
Starting margin. It erodes year over year across the product's remaining lifecycle, see Advanced assumptions.
Advanced assumptions
P50 default is 4; use 6–7 to reflect the repeat-study protection scenario.
As competitors enter and prices erode, margin typically falls 3 to 5% a year. Compounds across the lifecycle above.
Denominator for the ROI multiple. Defaults to the in-house BA/BE + dossier cost.
Price & share by entrant rank (auto-set by market, editable)
| Rank | Price, % of brand | Share, % |
|---|---|---|
| 1 | ||
| 2 | ||
| 3 | ||
| 4 | ||
| 5 | ||
| 6+ |
Illustrative model built on typical industry timelines and price-erosion patterns. Actual timelines, approval odds and pricing depend on molecule-specific factors; figures here are planning estimates, not guarantees.