Case Study Creation

Case Study Creation for Talosix EDC

Purpose

Produce customer case studies that demonstrate measurable impact of Talosix EDC on clinical trial operations. Case studies serve as mid-to-bottom funnel content for prospects evaluating EDC platforms, used by sales, marketing, and business development teams.

Case Study Structure

Standard Format: Problem / Solution / Results

1. Header Block

• Title: Action-oriented, include key metric if possible
  • Example: "Mid-Size CRO Reduces Study Build Time by 60% with Talosix EDC"
• Subtitle: One sentence elaborating on the context
• Quick stats sidebar: 3-4 headline metrics
• Customer profile: Organization type, size, therapeutic area, trial phase

2. Customer Profile (2-3 sentences)

• Organization type (sponsor, CRO, academic medical center, site network)
• Size and scope (number of trials, geography, therapeutic focus)
• Relevant context (growth stage, regulatory environment, portfolio complexity)
• NOTE: Anonymize or use approved customer name per agreement

3. The Challenge (200-300 words)

• Specific operational pain points before Talosix
• Quantify the problem where possible (time, cost, error rates, delays)
• Regulatory or compliance pressures
• Previous solution limitations
• Business impact of the status quo

4. The Solution (300-400 words)

• Why Talosix was selected (evaluation criteria, competitive differentiators)
• Implementation approach and timeline
• Key features or capabilities leveraged
• Integration with existing systems (CTMS, IRT/IWRS, safety databases, labs)
• Validation and go-live process
• Training and change management approach

5. The Results (200-300 words)

• Quantified outcomes with before/after comparisons
• Operational efficiency gains
• Data quality improvements
• Compliance and audit outcomes
• User adoption and satisfaction indicators
• Timeline from implementation to value realization

6. Customer Quote

• Direct quote from a named stakeholder (with approval) or anonymized role
• Should reinforce the most compelling result
• Keep to 2-3 sentences maximum

7. Call to Action

• Link to request a demo or speak with sales
• Link to related content (white paper, product page, webinar recording)

Key Metrics to Capture and Highlight

Study Build and Setup

• Study build time reduction (days/weeks saved)
• Number of eCRF iterations before finalization
• Time from protocol to first patient data entry
• Library/template reuse rate

Data Quality

• Query rate reduction (queries per subject or per page)
• Data entry error rate (before vs. after)
• Auto-query vs. manual query ratio
• Time to query resolution
• Percentage of clean data at database lock

Operational Efficiency

• Database lock cycle time reduction
• Number of studies managed per data manager
• Reduction in duplicate data entry
• Site training time to proficiency
• CRA monitoring visit preparation time

Compliance and Audit

• Audit findings related to EDC (before vs. after)
• 21 CFR Part 11 compliance audit outcomes
• CDISC compliance rate (CDASH, SDTM mapping accuracy)
• Inspection readiness score improvements

Cost Impact

• Total cost of ownership comparison
• Per-study or per-subject cost reduction
• FTE time savings (translated to dollar value)
• Vendor consolidation savings

Anonymization Guidelines

When Customer Allows Full Attribution

• Use company name, logo, and spokesperson name/title
• Reference specific therapeutic areas and trial phases
• Include exact metrics
• Customer reviews and approves final version

When Partial Anonymization Required

• Use descriptive identifiers: "A Top-20 Global CRO" or "A Mid-Size Oncology Sponsor"
• Generalize therapeutic area if needed: "oncology" rather than specific indication
• Use role titles without names: "VP of Clinical Data Management"
• Round metrics to nearest 5% or 10% to prevent identification
• Remove geographic specifics if identifying

When Full Anonymization Required

• Use generic descriptors: "A pharmaceutical company"
• Aggregate metrics across multiple customers if needed
• No identifying details about trial portfolio
• Focus on general capability demonstration
• Consider composite case study approach (clearly labeled)

Approval Workflow

Internal Steps

1. Sales/CSM identifies candidate — Flags customer with strong results and relationship
2. Marketing drafts interview questions — Tailored to known outcomes and use case
3. Customer interview conducted — 30-45 minute structured interview
4. Draft written — Following standard format above
5. Internal review — Marketing, product, and sales review for accuracy
6. Legal review — Check claims, compliance language, contractual obligations

Customer Approval Steps

7. Send draft to customer contact — With clear markup of quotes and attributions
8. Customer internal review — Allow 2-3 weeks for legal/PR review on their side
9. Incorporate feedback — Adjust per customer requests
10. Final sign-off — Written approval (email sufficient) before any publication
11. Annual re-approval — Check annually that customer is still comfortable with content

Approval Tracking

• Maintain a log of: customer name, case study title, approval date, approver name/role, approved channels (web, print, sales deck, conference), expiration/review date

Tone and Style

• Professional and credible — This is B2B content for clinical trial professionals
• Metrics-driven — Lead with numbers, support with narrative
• Respectful of customer — They are the hero, Talosix is the enabler
• Specific over general — "Reduced query rate from 12.3 to 4.1 per subject" beats "significantly improved data quality"
• Avoid superlatives — No "best," "only," "first" unless verifiably true
• Regulatory precision — Do not overstate compliance claims

Distribution Channels

• Website resource library — Gated (require email) or ungated based on strategy
• Sales enablement — PDF format for email attachment, one-pager for meetings
• Conference materials — Printed or digital for booth and session handouts
• Social media — Pull 2-3 key stats for LinkedIn posts with link to full study
• Email campaigns — Include in nurture sequences matched to similar prospect profiles
• Webinars — Customer co-presentation format for high-value case studies

Output Deliverables

When creating a case study, produce:

1. Full case study document (800-1,200 words)
2. One-page summary version (PDF-ready, 400-500 words)
3. Key stats card (3-4 metrics with visual layout guidance)
4. Two LinkedIn post variants promoting the case study
5. Email snippet for sales team to share with prospects
6. Interview question template (if interview has not yet been conducted)