roi-calculator

name	roi-calculator
description	Build custom ROI calculators for Talosix EDC prospects, factoring in study setup time, data query reduction, monitoring efficiency, and industry benchmarks to quantify the business case.

ROI Calculator Builder

Purpose

Create prospect-specific ROI analyses that quantify the financial and operational benefits of adopting Talosix EDC. The calculator should use a combination of the prospect's own data (when available) and validated industry benchmarks to build a credible, defensible business case.

When to Use

• During or after discovery to quantify pain points financially
• As part of a formal proposal to justify investment
• When a deal is stalled and needs a business case to move forward
• For executive-level conversations where financial justification is required
• At renewal to demonstrate realized value

Information Gathering

Prospect-Specific Inputs (Preferred)

Request these from the prospect when possible:

Input	Description	If Unknown, Use Benchmark
Number of active studies	Concurrent studies in the portfolio	Varies by company type
Average sites per study	Sites across all active studies	50-150 (Phase III)
Average subjects per study	Enrolled subjects per study	200-500 (Phase III)
Average eCRF pages per subject	Data volume indicator	80-150 pages
Average study build time	Weeks from protocol final to go-live	10-16 weeks
Current query rate	Queries per 1000 eCRF fields	8-15%
Average query resolution time	Days from query open to close	5-14 days
SDV percentage	Source data verification rate	80-100%
Cost per monitoring visit	Loaded cost per on-site visit	$1,500-$3,000
Annual EDC spend	Current EDC licensing + services	Varies
Time from LPLV to DB lock	Weeks after last patient last visit	4-8 weeks
FTE data management cost	Fully loaded annual cost per DM	$85,000-$130,000
Study amendments per study	Average protocol amendments	2-3 per study
Time to implement amendment	Weeks to deploy EDC amendment	2-6 weeks

Industry Benchmarks

Use these peer-reviewed and industry-sourced benchmarks as defaults:

Study Setup:

• Average EDC study build time: 12 weeks (Tufts CSDD)
• Cost of one week delay in study start: $37,000-$600,000 depending on therapeutic area and phase (Tufts CSDD)
• Average cost to build and validate an EDC study: $50,000-$200,000

Data Quality:

• Industry average query rate: 10-15 queries per 100 eCRF pages (SCDM benchmarks)
• Cost per query lifecycle (open, send, resolve, close): $50-$75 (industry estimates)
• Percentage of queries that are avoidable with better edit checks: 30-50%

Monitoring:

• Average monitoring visit cost (on-site): $2,000-$3,000 including travel
• Average monitoring visits per site per year: 6-10
• RBM can reduce on-site visits by 25-50% (TransCelerate benchmarks)

Database Lock:

• Average time from LPLV to DB lock: 6-8 weeks (traditional), 2-4 weeks (modern EDC)
• Cost per day of delayed NDA/BLA submission: varies by indication, can exceed $1M/day for blockbuster drugs
• Revenue at risk per month of delayed approval: drug-specific

ROI Model Components

1. Study Setup Acceleration

Current setup time: [X] weeks
Talosix projected setup time: [Y] weeks (typically 40-60% reduction)
Time saved: [X - Y] weeks per study
Studies per year: [N]

Annual time saved: (X - Y) x N weeks
Financial impact: (X - Y) x N x [cost per week of delay]

Value drivers:

• Form library with reusable components reduces design time
• No-code configuration eliminates programming bottleneck
• Integrated validation reduces separate testing cycles
• Template-based study setup for similar protocols

2. Data Query Reduction

Current query rate: [X] per 100 eCRF pages
Talosix projected query rate: [Y] per 100 eCRF pages (typically 30-50% reduction)
Total eCRF pages per study: [subjects] x [pages per subject]
Queries avoided per study: (X - Y) / 100 x [total pages]

Cost per query: $[50-75]
Annual savings: Queries avoided x N studies x cost per query

FTE impact: Queries avoided x [time per query] / [annual work hours] = FTEs redeployed

Value drivers:

• Real-time edit checks catch errors at the point of entry
• Conditional logic prevents impossible data combinations
• Smart defaults reduce transcription errors
• Better site UX reduces training-related entry errors

3. Monitoring Efficiency

Current monitoring visits per site per year: [X]
Sites across all studies: [N]
Total annual monitoring visits: X x N
Cost per visit: $[2,000-3,000]
Current annual monitoring cost: X x N x cost per visit

With Talosix RBM support:
Projected visit reduction: [25-40%]
Visits eliminated: X x N x reduction percentage
Annual savings: Visits eliminated x cost per visit

Value drivers:

• Real-time data quality dashboards enable central monitoring
• KRI tracking identifies sites needing attention vs. routine visits
• Remote data review reduces need for on-site SDV
• Automated compliance checks flag issues before monitor visits

4. Database Lock Acceleration

Current LPLV-to-lock time: [X] weeks
Talosix projected time: [Y] weeks (typically 30-50% reduction)
Time saved per study: (X - Y) weeks

For submission-critical studies:
Revenue impact per week of earlier approval: $[estimate based on drug revenue projections]
Probability-adjusted value: Revenue per week x (X - Y) x probability of approval

Value drivers:

• Continuous data cleaning during the study (not batch at end)
• Automated CDISC mapping reduces post-lock data transformation
• Real-time data quality metrics enable rolling database lock
• Fewer outstanding queries at LPLV

5. Amendment Agility

Amendments per study per year: [X]
Current time to implement amendment in EDC: [Y] weeks
Talosix projected implementation time: [Z] weeks
Time saved per amendment: (Y - Z) weeks

Annual time saved: X x N studies x (Y - Z) weeks
Impact: Reduced enrollment delays, faster protocol compliance
Financial value: Time saved x [cost per week of enrollment delay]

6. Operational Efficiency (FTE Optimization)

Current DM FTEs dedicated to EDC-related tasks: [X]
Tasks automated or reduced by Talosix:
  - Query management: [X%] time reduction
  - Report generation: [X%] time reduction
  - Study build: [X%] time reduction
  - Amendment implementation: [X%] time reduction

FTE time recaptured: Sum of reductions
Financial value: FTEs recaptured x loaded cost per FTE

ROI Summary Table

Category	Current Annual Cost	Projected w/ Talosix	Annual Savings
Study Setup	$X	$Y	$Z
Data Queries	$X	$Y	$Z
Monitoring	$X	$Y	$Z
Database Lock	$X	$Y	$Z
Amendments	$X	$Y	$Z
FTE Optimization	$X	$Y	$Z
Total Operational Savings			$Z
Talosix Investment			($A)
Net Annual Benefit			$B
ROI			X%
Payback Period			X months

ROI = (Net Annual Benefit / Total Talosix Investment) x 100
Payback Period = Total Talosix Investment / (Net Annual Benefit / 12)

Sensitivity Analysis

Present three scenarios to account for uncertainty:

Scenario	Assumptions	ROI	Payback
Conservative	Low-end improvements (25th percentile)	X%	X months
Expected	Mid-range improvements (50th percentile)	X%	X months
Optimistic	High-end improvements (75th percentile)	X%	X months

Credibility Guidelines

• Cite sources for all industry benchmarks (Tufts CSDD, SCDM, TransCelerate)
• Use prospect's own data whenever available; benchmarks are fallbacks
• Be conservative in projections; under-promise and over-deliver
• Exclude soft benefits from the primary ROI calculation (improved site satisfaction, reduced audit risk) but mention them qualitatively
• Show your math -- every number should be traceable to an input assumption
• Acknowledge limitations -- state that actual results depend on implementation quality and adoption

Output Format

1. Executive ROI Summary - One-page visual summary with headline ROI, payback period, and top 3 value drivers
2. Detailed Model - Full calculation workbook with all inputs, formulas, and outputs
3. Assumptions Document - Every input, its source (prospect-provided or benchmark), and confidence level
4. Sensitivity Analysis - Three-scenario view showing ROI range
5. Presentation Slides - 3-5 slides suitable for executive review