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HealFast – AI

Accelerating drug validation for Patients who can’t afford to wait

Deepak Sreeram

Mukesh Kala

AP Reddy

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A Global Crisis Hidden in the Fine Print

80% of clinical trials fail to meet timelines due to fragmented data and delayed reviews.(Clinical Trials Arena)

Manual review - 500-1,000 hours per trial. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7342338/)

40% of submissions require rework (https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-11-79)

Behind every headline is a patient waiting…

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One Delay. One Patient. One Missed Opportunity.

Patient: SONA301-MRC-002�Age: 43�Diagnosis: Type 2 Diabetes Mellitus�Trial Drug: Sonivel™ (agentixumab)

AE Form

Consent

Lab Report

Due to critical compliance flag on ICF and out-of-range lab values requiring review.

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Attachments saved manually to folder

Users open and read each PDF manually

Data is copied into Excel/EDC manually

Reviewers spot issues (missing ICF signature)

Clarifications sent over email/slack

Decision recorded and data saved for Audit

Clinical PDFs (Lab, ICF, AE) received via email

The Hidden delays In drug access

12+ months of regulatory bottlenecks delay life‑saving treatments

70% of time spent on manual review of AE forms, lab reports, and consent docs

Patients suffer as therapies wait in the pipeline

A broken bridge between data and decisions

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Meet HealFast-AI

Proposed Solution / To-Be Workflow

Clinical PDFs (Lab, ICF, AE) received via email

Download and store documents

Extraction of Key Fields

Centralized Storage

Agentic Validation and Compliance Checks

Human Escalation

Reporting

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Platform: n8n Low‑Code

Techniques: Regex Parsing, Prompt Analysis

Input: Real‑world simulated clinical docs

Output: Validated JSON + Risk Category

Raw PDF’s

{

"AE": "Valid",

"Lab": "Valid",

"Consent": "Valid"

}

Structured Output

LLM : Gemini

Integrations : Gmail , Google Sheets , Dropbox

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From Hours to Minutes

CTV‑45210: Enrolled. Treatment started.

KPI	Current Manual	With HealFast-AI
Review Time(5 Patients)	40–60 hrs	<6 hrs (85%+ Reduction)
Accuracy (First Pass Quality)	85–90%	>98%
Protocol Deviation Detection	Days to Weeks (Delayed)	Near Real-Time
Compliance Risk	High (Frequent audit flags)	Low (Built-in regulatory checks)
Reconciliation	Manual & Time-Consuming	Automated & Continuous
Human Effort	High	Low
Patient Safety (SAE Flagging)	12–24+ hrs (Delayed)	<1 hr (90%+ Faster Escalation)

Benefits, Impact and Outcomes

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HealFast – AI

Process in Action

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Beyond Automation -> Toward Acceleration

Short‑Term Goals

Support multiple languages

Plug into sponsor workflows

Long‑Term Goal

Vision 2026 - From Labs to Lives

Global adoption to reduce trial approval timelines by 30%

Accelerate approvals

Implement Feedback Learning Loop

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For Every Patient Who Can’t Afford to Wait

"HealFast AI isn’t just a tool. It’s a bridge from paperwork to patients."�"Because time is medicine."

Team HealFast AI

THANK YOU