nroze22 Business Case Builder
Build rigorous business cases for Talosix EDC feature investments, grounded in clinical trial industry economics and competitive dynamics.
Workflow
Gather Input: Ask the user for:
- Feature/investment being evaluated
- Target customer segment (pharma sponsors, CROs, academic sites, biotechs)
- Investment scope (build vs. buy vs. partner)
- Any existing data (customer requests, win/loss data, competitor moves)
Research: Pull from available sources:
- Jira: related customer requests, feature votes
- Confluence: prior analyses, customer feedback, market research
- Use industry knowledge of the clinical trial EDC market
Generate the Business Case document.
Business Case Template
Executive Summary
- 3-5 sentence overview: what, why, expected return, recommendation
- Go / No-Go / Defer recommendation with confidence level
1. Opportunity Description
- Feature/Investment: Clear description
- Problem Being Solved: For whom, how severe
- Strategic Alignment: How this fits Talosix product strategy
- Trigger: What prompted this evaluation (customer request, competitive pressure, regulatory change, market trend)
2. Market Analysis
Market Size
- TAM: Total addressable market for EDC/clinical trial technology
- SAM: Serviceable addressable market for this specific capability
- SOM: Realistic serviceable obtainable market for Talosix
Industry Context
Reference these clinical trial market benchmarks:
- Global clinical trial market: ~$80B+ and growing ~6% CAGR
- EDC market segment: ~$2-3B
- Average clinical trial cost by phase: Phase I ($4M), Phase II ($13M), Phase III ($20M+)
- Average EDC cost as % of trial budget: 2-5%
- Key trends: decentralized trials, risk-based monitoring, AI/ML adoption, patient-centricity
Customer Segments
| Segment | Size | Willingness to Pay | Talosix Penetration |
|---|---|---|---|
| Top 20 Pharma | [X] | High | [Current %] |
| Mid-size Pharma/Biotech | [X] | Medium-High | [Current %] |
| CROs | [X] | Medium | [Current %] |
| Academic/Government | [X] | Low-Medium | [Current %] |
3. Competitive Landscape
- Medidata Rave: [Current capability and positioning]
- Veeva Vault EDC: [Current capability and positioning]
- Oracle InForm / Clinical One: [Current capability and positioning]
- Castor / Decentralized: [Current capability and positioning]
- Others: REDCap, OpenClinica, Climedo, etc.
- Competitive gap: What advantage does this give Talosix?
4. Financial Analysis
Revenue Impact
- New ARR potential: Number of deals influenced x average deal size uplift
- Retention impact: Churn reduction from addressing unmet need
- Upsell potential: Expansion revenue from existing customers
- Deal win rate impact: Competitive win rate improvement
Cost Estimate
| Category | One-Time | Recurring (Annual) |
|---|---|---|
| Engineering (FTEs x months) | $[X] | $[X] |
| Design/UX | $[X] | -- |
| QA/Validation | $[X] | $[X] |
| Infrastructure | $[X] | $[X] |
| Regulatory/Compliance | $[X] | $[X] |
| Training/Enablement | $[X] | $[X] |
| Total | $[X] | $[X] |
ROI Calculation
- Payback Period: Months to recover investment
- 3-Year NPV: Net present value over 3 years
- IRR: Internal rate of return
- Break-even: Number of customers/deals needed
5. Risk Assessment
| Risk | Probability | Impact | Mitigation |
|---|---|---|---|
| Regulatory complexity underestimated | [H/M/L] | [H/M/L] | [Strategy] |
| Customer adoption slower than projected | [H/M/L] | [H/M/L] | [Strategy] |
| Competitive response | [H/M/L] | [H/M/L] | [Strategy] |
| Technical complexity | [H/M/L] | [H/M/L] | [Strategy] |
| Validation burden | [H/M/L] | [H/M/L] | [Strategy] |
6. Implementation Approach
- Phase 1 (MVP): Scope, timeline, cost
- Phase 2 (Enhancement): Additional capabilities
- Phase 3 (Scale): Full feature parity with market leaders
- Build vs. buy vs. partner recommendation
7. Clinical Trial Regulatory Considerations
- 21 CFR Part 11 implications and validation effort
- Impact on existing validated state (regression risk)
- Customer re-validation requirements and communication
- GxP documentation deliverables
8. Success Metrics and Tracking
- Leading indicators (pipeline mentions, demo requests, trial signups)
- Lagging indicators (revenue, adoption, retention)
- Review cadence: 30/60/90 day checkpoints post-launch
9. Recommendation
- Clear Go / No-Go / Defer with rationale
- If Go: requested budget, timeline, team allocation
- If Defer: conditions that would change the recommendation
- Next steps and decision owners