business-case

name	business-case
description	Build comprehensive business cases for new Talosix EDC features and investments, including market analysis, ROI projections, and clinical trial industry metrics.
allowed-tools	mcp__claude_ai_Atlassian__searchJiraIssuesUsingJql, mcp__claude_ai_Atlassian__searchConfluenceUsingCql, mcp__claude_ai_Atlassian__getConfluencePage, mcp__claude_ai_Atlassian__createConfluencePage, WebSearch
argument-hint	[Feature or investment to evaluate, e.g. 'eConsent module', 'RTSM integration', 'AI-powered edit checks']

Business Case Builder

Build rigorous business cases for Talosix EDC feature investments, grounded in clinical trial industry economics and competitive dynamics.

Workflow

1. 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)

2. 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

3. 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