Clinical Protocol Summarizer

Converts clinical protocols into plain-language investigator summaries. Auto-generates patient consent form language from protocol synopsis.

01 PROBLEM STATEMENT

Complex Protocols are Delaying Site Initiation and Patient Consent

A pharmaceutical sponsor running multi-site Phase III trials faced recurring site initiation delays. Clinical protocols were highly technical and difficult for investigators to digest quickly. Patient consent forms required manual rewriting to match protocol language. Site staff spent weeks preparing for initiation visits. Protocol amendments triggered cascading consent form updates. Screen failure rates were elevated due to misunderstood eligibility criteria.

02 CURRENT CHALLENGES

What the Sponsor was Struggling With

Site Initiation Delay

Weeks per site

Investigators struggled to digest complex technical protocols. Site initiation delayed by weeks on every amendment.

Patient Consent Complexity

Misunderstanding risk

Patient consent forms written in technical language. Misunderstanding elevated and screen failure rates increased.

Protocol Amendment Cascade

Manual consent updates

Protocol amendments triggered manual consent form updates across all active sites. Cascade effect overwhelmed teams.

Investigator Preparation Time

Manual summarisation

Site staff spent weeks manually preparing investigator summaries. Time-consuming, inconsistent, and error-prone.

03 SOLUTION OVERVIEW

STAR’s approach – AINE Clinical Protocol Summariser

STAR Systems deployed AINE Clinical Protocol Summariser with CTMS API or document share for protocol ingestion. IRB/IEC submission portal for output formatting. Protocol amendment version tracking. Language: English primary, vernacular adaptation for Indian sites. CRA reviews all AI summaries before site distribution. Consent language reviewed by IRB coordinator. STAR updates for ICH E6(R3) guideline changes.

AI PATTERN

Document Summarisation + Plain-Language Translation + Consent Form Generation

04 WORKFLOW PROCESS

Step-by-Step: How Protocols are Summarised and Consent Language is Generated

Step 1 (Protocol Ingestion): Protocol ingested from CTMS or document share. Amendment version tracking maintained automatically across all active sites.

Step 2 (Investigator Summary): AI generates a plain-language investigator summary covering eligibility criteria, procedures, and safety requirements. Available within hours of ingestion.

Step 3 (Consent Form Language): Consent language generated directly from the protocol synopsis. Vernacular adaptation applied for Indian sites to ensure true patient understanding.

Step 4 (CRA Review): CRA reviews all AI-generated summaries before site distribution. Can edit or override any section to ensure accuracy and compliance.

Step 5 (IRB/IEC Submission): IRB coordinator reviews consent language. Output formatted for IRB/IEC portal submission with no manual reformatting required.

Step 6 (Guideline Updates): STAR updates the platform for ICH E6(R3) guideline changes. Templates refresh automatically to maintain ongoing compliance.

05 KEY FEATURES

What the Platform Does

CTMS Integration:

Connects via CTMS API or document share. Protocol amendment version tracking maintained across all active sites automatically.

Plain-Language Investigator Summaries:

Converts complex clinical protocols into clear investigator summaries. Covers eligibility criteria, procedures, and safety requirements in readable language.

Auto-Generated Consent Language:

Consent language generated directly from protocol synopsis. Vernacular adaptation available for Indian sites to ensure genuine patient understanding.

IRB/IEC Submission Formatting:

Output formatted for IRB/IEC portal submission. IRB coordinator reviews consent language before any distribution or submission.

CRA Review Gate:

CRA reviews all AI-generated content before site distribution. Accuracy gate ensures no summary reaches sites without human review and approval.

ICH E6(R3) Guideline Compliance:

STAR updates platform templates for ICH E6(R3) guideline changes. Compliance maintained continuously without manual template management.

06 BUSINESS OUTCOMES

What Changes After Go-Live

Hours

Site Initiation Time reduced from weeks to hours per amendment

Clear

Patient Consent Language reduces misunderstanding and screen failure

Better

Sites Prepared and Informed trial execution quality improved

Genuine

Patient Centricity consent materials truly understandable

COO

Site initiation time reduced: investigator summaries available within hours of protocol amendment.
Patient consent process improved: clear language reduces misunderstanding and screen failure rate.

CEO

Trial execution quality improves: sites better prepared and informed before initiation visits.
Patient centricity delivered: consent materials are genuinely understandable across all sites.

CFO

Trial delay cost avoidance: each month saved on a Phase III study worth millions in delayed revenue.
Site preparation cost reduced through faster, clearer materials delivered at scale.

07 REAL-WORLD SCENARIO

A Day in the Life – Before and After

Before	After
Amendment issued. Staff spend 2 weeks preparing summaries manually. Site initiation visit delayed.	Amendment issued. AI summary generated within hours. Initiation visit proceeds on schedule.
Consent written in technical language. Patients struggle to understand. Screen failure rate elevated.	Plain-language consent generated automatically. Patients understand clearly. Screen failure rate reduced.
Clarifying questions raised during initiation visit. Protocol complexity slows activation. Follow-ups required.	Clear summary delivered before visit. Site activation faster. Fewer questions. Investigators better prepared.
Amendment triggers manual consent updates across 50 sites. Team overwhelmed. Weeks of delays cascade.	Automated updates generated across all sites. CRA reviews drafts. Sites receive updated materials within days.

08 ROI AND VALUE JUSTIFICATION

Why the Numbers Work

Value Driver	Indicative Impact	How It Is Realised
Site initiation time	Weeks recovered per protocol amendment	Summaries generated in hours. Site preparation accelerated significantly.
Patient consent clarity	Screen failure rate reduction	Plain language reduces misunderstanding. Patients better informed before enrolment.
Trial delay cost avoidance	Each month saved worth millions in delayed revenue	Trial acceleration through faster site activation. Launch timeline protected.
CRA productivity	Time redirected from manual summarisation	CRA reviews AI drafts rather than creating from scratch. Time freed for monitoring.
Patient centricity	Consent materials genuinely understandable	Vernacular adaptation for Indian sites. Plain language ensures true informed consent.

09 NEXT STEPS

Discovery Call

30-min call to map your CTMS landscape, protocol complexity, and consent form challenges.

Pilot Scoping

We identify 1–2 protocols for a 6-week pilot with live CTMS integration and consent generation.

Pilot Delivery

AI-generated summaries and consent language run on selected protocols. CRA review time tracked.

Business Case

Site initiation time reduction, screen failure improvement, and CRA productivity measured.

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Clinical Protocol Summarizer