# IRB Proxy

*/Opportunities/IRB_Proxy*

## Opportunity Overview

**Wedge**: The beachhead focuses on Phase I oncology clinical trial protocols at mid-sized Contract Research Organizations. Oncology trials face the highest IRB scrutiny and longest delay times, making the pain acute and measurable in lost daily revenue. After securing CROs, the product expands to academic medical centers and eventually automates the drafting of the informed consent forms.
**Timing**: Context window expansions in large language models now allow ingestion of entire 100-page trial protocols, investigator brochures, and informed consent forms simultaneously. Concurrently, regulators enforce stricter documentation standards, increasing the financial penalty for incomplete first-pass submissions.
**Why This I C P**: Contract Research Organizations and university regulatory affairs offices bear the direct financial cost of delayed clinical trials. They possess immediate budget authority to procure software that accelerates protocol clearance and prevents measurable trial delays.
**Size Of Prize**: There are roughly 100,000 active clinical and academic research labs globally that submit IRB protocols. At an annual software spend of $12,000 per lab for compliance and protocol acceleration tools, the total addressable prize is $1.2B.
**Gap Narrative**: Clinical and academic researchers wait four to eight weeks for Institutional Review Board feedback, stalling trials and grant funding. Current compliance software only tracks submission status rather than evaluating the substantive text of the protocol for ethical risks and regulatory alignment. Researchers need immediate, substantive pre-review to guarantee first-pass IRB approval.
**Defensibility**: Defensibility stems from workflow lock-in and a proprietary data loop of localized feedback. As the system ingests specific institutional board preferences and historical rejection reasons, it builds a localized rule engine that generic models lack. Switching costs rise because moving to a new system means losing the institutional memory of what a specific hospital IRB requires for approval.
**Why This Thesis**: The Service-as-Software thesis fits because IRB review is a cognitive labor bottleneck involving deep document analysis against static regulatory guidelines. Packaging this as software replaces expensive external regulatory consultants while executing the exact same substantive review task.

## Opportunity Linked Thesis

**Thesis**: [Service-as-Software](/Theses/Service-as-Software)

## Opportunity Linked I C P

**Icp**: [Clinical Research Organization](/CompanyTypes/Clinical_Research_Organization)

## Opportunity Market Sizing

_Illustrative — target and order-of-magnitude estimate figures, not an achieved track record (this Thing is concept-stage)._

**S A M**: ~$200M-300M US-based clinical research organizations
**S O M**: ~$10M-25M
**T A M**: ~8,000-10,000 global clinical research entities x ~$75,000/yr ≈ ~$600M-750M
**Growth Rate**: ~10-14%/yr, driven by expanding decentralized clinical trial volumes and strict regulatory review turnarounds
**Paid Comparable Spend**: ~$80,000-150,000/yr on dedicated regulatory affairs FTEs, manual compliance tracking, and legacy eRegulatory software

## Opportunity Incumbents

- [Cayuse Human Ethics](/Products/Cayuse_Human_Ethics) — Tool
- [Advarra](/Products/Advarra) — Service
- [WCG IRB](/Products/WCG_IRB) — Service
- [Huron Research Suite](/Products/Huron_Research_Suite) — Tool
- [InfoEd Global](/Products/InfoEd_Global) — Tool
- [Internal Custom Portals](/Products/Internal_Custom_Portals) — DIY

## Opportunity Win Conditions

**Kill Thresholds**:
- Sales cycle duration > 120 days for mid-market clinical sites
- Active protocol migration < 40% within first 60 days of deployment
- Direct portal login fallback > 50% after week two
- CAC > $15,000 per mid-market site
**Leading Metrics**:
- Protocol formatting time-to-completion
- First-pass IRB submission acceptance rate
- Direct portal login fallback percentage
- Document version conflict frequency
**What Proves Right**: Clinical research coordinators use the proxy to format and submit initial protocols and amendments. Regulatory affairs teams sign $75,000 annual contracts without requiring a pilot period exceeding 30 days. Monthly cohorts route more than 80% of their institutional documents through the system rather than reverting to legacy eRegulatory portals.
**What Proves Wrong**: Research coordinators abandon the tool because IRB boards mandate proprietary portal submissions that block automated data entry. Compliance officers refuse deployment due to perceived audit risks in maintaining a proxy layer. Institutional IT security reviews stall the sales pipeline beyond six months.

## Opportunity Build Profile

**Hardest Part**: Modeling the subjective localized risk thresholds of specific institutional boards and accurately flagging ethical gaps in unstructured research protocols without burying researchers in false-positive warnings.
**Min Viable Scope**: Support only minimal-risk exempt behavioral and social science studies to evaluate consent forms and data privacy. Deliberately leave out FDA-regulated biomedical trials, full-board review routing, and multi-site reliance agreements.
**Cold Start Problem**: Historical IRB decisions and raw protocol drafts are locked inside institutional compliance offices under strict confidentiality rules. Break this by running open-records requests on public state universities and partnering with a single high-volume research office to ingest their specific historical feedback loops.
**Time To First Value**: Minutes to generate the first gap-analysis report after a researcher uploads a draft protocol document.
**Data Moat Available**: true
**Technical Difficulty**: High

## Neighborhood

### Where the gap lives

- [Sociology and Anthropology](/Knowledge/Sociology_and_Anthropology) — latent gap · Knowledge

### Incumbent in

- [In-House Built Portals](/Products/In-House_Built_Portals) — incumbent in · Products
- [Advarra](/Products/Advarra) — incumbent in · Products
- [Cayuse Human Ethics](/Products/Cayuse_Human_Ethics) — incumbent in · Products
- [Huron Research Suite](/Products/Huron_Research_Suite) — incumbent in · Products
- [WCG IRB](/Products/WCG_IRB) — incumbent in · Products
- [InfoEd Global](/Products/InfoEd_Global) — incumbent in · Products

### Applies thesis

- [Clinical Research Organization](/CompanyTypes/Clinical_Research_Organization) — applies thesis · CompanyTypes

### Embodies

- [Service-as-Software](/Theses/Service-as-Software) — embodies · Theses

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