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AI-Powered Clinical Trial Intelligence

Next-generation AI-powered platform built to streamline and automate key components of clinical trial operations. It brings intelligence and automation to protocol development, data management, document generation, and regulatory readiness.

AI Core Features

eProtocol Creation

eProtocol Creation

Uses advanced generative AI to develop structured, GCP-compliant protocol documents from initial synopsis.

eCRF & eCSR Generation

eCRF & eCSR Generation

Automates the creation of eCRFs and clinical study reports by ingesting protocol, statistical analysis plans (SAP), and TLFs. AI generates up to 70% of CSR content in a compliant and editable Word format, significantly reducing time and manual rework.

AI-Powered Patient & Case Narratives

AI-Powered Patient & Case Narratives

Extracts and summarizes clinical history, concomitant medications, AE timelines, and relevant lab results to generate structured patient narratives. Narratives align with regulatory standards (e.g., CIOMS) and enhance consistency and quality across global trials.

Automated Data Extraction (OCR + NLP)

Automated Data Extraction (OCR + NLP)

Ingests scanned or digital documents (e.g., safety reports, lab results, discharge summaries) and converts them into structured formats ready for import into CTMS or EDC systems.

PHI Detection & Redaction

PHI Detection & Redaction

Uses AI to automatically detect and redact sensitive patient information (PHI) from images (including DICOM), documents, and scanned PDFs. Supports HIPAA, GDPR, and 21 CFR Part 11 compliance.

eSDV Assistant (AI-Powered Source Data Verification)

eSDV Assistant (AI-Powered Source Data Verification)

Compares source documents with EDC entries, flags mismatches, and auto-generates clarification queries. Reduces the burden on clinical monitors and supports risk-based and remote monitoring strategies

AI-Powered Pharmacovigilance

AI-driven pharmacovigilance (PV) automation platform designed to streamline the detection, extraction, classification, and reporting of adverse events from structured and unstructured medical literature, case reports, and safety databases. Tailored for the life sciences domain, enhances regulatory compliance, reduces manual effort, and improves safety decision-making.

AI Core Features

Automated ICSR Triage & Classification

Automated ICSR Triage & Classification

Classifies safety data into valid/invalid, serious/non-serious, expected/unexpected using regulatory-aligned AI models.

AI-Powered Causality & Seriousness Assessment

AI-Powered Causality & Seriousness Assessment

Supports causality assessments using WHO-UMC/Naranjo-aligned AI frameworks.

NER-Driven Data Abstraction

NER-Driven Data Abstraction

Automatically extracts key pharmacovigilance entities (e.g., suspect drug, AE, patient details) from unstructured content.

Narrative Generation & Summarization

Narrative Generation & Summarization

Produces high-quality, regulatory-aligned narratives and summaries using fine-tuned LLMs.

Signal Detection & Pattern Recognition

Signal Detection & Pattern Recognition

Identifies early trends and clusters across multi-source data using unsupervised and time-series models.

Signal Detection & Pattern Recognition

Auto Task Assignment & Workflow Routing

Assigns safety cases dynamically based on urgency, type, and reviewer profile.

Assigns safety cases dynamically based on urgency, type, and reviewer profile.

Audit Trail & Explainability

Logs and justifies AI decisions using interpretable models with SHAP/LIME support.

Transcription & Translation

Transcription & Translation

Transcribes audio from calls, videos, or scanned documents into structured text. Supports real-time translation of non-English content for global compliance and reviewer efficiency.

AI-Powered Pharmacovigilance

AI-driven pharmacovigilance (PV) automation platform designed to streamline the detection, extraction, classification, and reporting of adverse events from structured and unstructured medical literature, case reports, and safety databases. Tailored for the life sciences domain, enhances regulatory compliance, reduces manual effort, and improves safety decision-making.

AI Core Features

Automated ICSR Triage & Classification

Automated ICSR Triage & Classification

Classifies safety data into valid/invalid, serious/non-serious, expected/unexpected using regulatory-aligned AI models.

AI-Powered Causality & Seriousness Assessment

AI-Powered Causality & Seriousness Assessment

Supports causality assessments using WHO-UMC/Naranjo-aligned AI frameworks.

NER-Driven Data Abstraction

NER-Driven Data Abstraction

Automatically extracts key pharmacovigilance entities (e.g., suspect drug, AE, patient details) from unstructured content.

Narrative Generation & Summarization

Narrative Generation & Summarization

Produces high-quality, regulatory-aligned narratives and summaries using fine-tuned LLMs.

Signal Detection & Pattern Recognition

Signal Detection & Pattern Recognition

Identifies early trends and clusters across multi-source data using unsupervised and time-series models.

Signal Detection & Pattern Recognition

Auto Task Assignment & Workflow Routing

Assigns safety cases dynamically based on urgency, type, and reviewer profile.

Assigns safety cases dynamically based on urgency, type, and reviewer profile.

Audit Trail & Explainability

Logs and justifies AI decisions using interpretable models with SHAP/LIME support.

Transcription & Translation

Transcription & Translation

Transcribes audio from calls, videos, or scanned documents into structured text. Supports real-time translation of non-English content for global compliance and reviewer efficiency.

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