crypta. | Tesserblu

/ CDMS

Literature Review & Monitoring

Never miss a safety signal hiding in the scientific literature.

Crypta automates the systematic literature monitoring process required by GVP Module VI: structured searches across PubMed, Embase and proprietary databases, AI-powered relevance screening, duplicate detection, and direct case creation in Salvus ICSR for qualifying articles.

Key capabilities

Multi-database Search

AI Relevance Screening

Duplicate Detection

Structured Review Workflow

Case Conversion

SUSAR / Expedited Identification

PubMed + Embase

+ proprietary databases

≥ 99.4%

AI screening recall rate

< 24h

Search-to-triage pipeline

GVP Module VI

Fully compliant

What it does

All the capability, none of the complexity.

Crypta automates the systematic literature monitoring process required by GVP Module VI: structured searches across PubMed, Embase and proprietary databases, AI-powered relevance screening, duplicate detection, and direct case creation in Salvus ICSR for qualifying articles.

01 Multi-database Search

Structured searches across PubMed, Embase, BIOSIS, IPA, and configurable proprietary databases. Search strategies versioned and auditable.

02 AI Relevance Screening

ML classifier assigns relevance scores to every retrieved article. Threshold-based routing: irrelevant articles auto-excluded with sampling; borderline articles queue for human decision.

03 Duplicate Detection

Deduplication across search databases and against the existing ICSR case database — preventing the same case being processed twice.

04 Structured Review Workflow

Articles flow through configurable multi-stage review (abstract → full text → medical assessment). Team assignments, SLAs and workload-balancing supported.

05 Case Conversion

Qualifying articles convert to structured ICSR records in Salvus ICSR with citation, patient/reporter fields pre-populated and article PDF attached.

06 SUSAR / Expedited Identification

Automatic flagging of articles describing serious unexpected reactions in clinical trials with expedited routing and 15-day clock notification.

07 Search Strategy Management

Build, version and compare search strategies per product and jurisdiction. Periodic execution scheduling with drift monitoring.

08 Audit & Evidence Package

Complete audit trail from search through human decisions to case creation — exportable as a GVP VI compliance evidence package.

How it works

From day one to every day after.

A typical journey through Literature Review & Monitoring — from onboarding to steady-state operations.

1

2

3

4 Strategy setup

Import the study definition from EDC; configure validation rules, coding dictionaries and the DMP checklist.

Automated execution

Crypta runs scheduled database searches, retrieves full-text PDFs for qualifying abstracts, and applies AI relevance scoring.

Human review

Reviewers work through the triage queue: irrelevant articles closed with reasons; relevant articles progress to medical assessment.

Case creation

Qualifying articles become ICSR cases in Salvus ICSR. Periodic literature reports (cumulative listing, SPC gap analysis) generated.

See It in Action

Watch Literature Review & Monitoring in action.

A guided walkthrough of the key workflows — built for Pharmacovigilance teams who need to see it to believe it.

.

How to add your demo video

1, Upload the Literature Review & Monitoring demo to YouTube.

2. Copy the video ID from the URL — the part after watch?v=

3, In the HTML above, find: data-vid="PASTE_VIDEO_ID_HERE"

4. Replace PASTE_VIDEO_ID_HERE with your actual video ID.

5. Save & deploy — the play button handles the rest automatically.

Integrations

Connects where you need it to.

Clinical Data Management System is designed to work with the rest of the Salvus platform — and with third-party systems your team already uses.

/ CDMS

Literature Review & Monitoring

Never miss a safety signal hiding in the scientific literature.

Crypta automates the systematic literature monitoring process required by GVP Module VI: structured searches across PubMed, Embase and proprietary databases, AI-powered relevance screening, duplicate detection, and direct case creation in Salvus ICSR for qualifying articles.

Key capabilities

Multi-database Search

AI Relevance Screening

Duplicate Detection

Structured Review Workflow

Case Conversion

SUSAR / Expedited Identification

PubMed + Embase

+ proprietary databases

≥ 99.4%

AI screening recall rate

< 24h

Search-to-triage pipeline

GVP Module VI

Fully compliant

What it does

All the capability, none of the complexity.

Crypta automates the systematic literature monitoring process required by GVP Module VI: structured searches across PubMed, Embase and proprietary databases, AI-powered relevance screening, duplicate detection, and direct case creation in Salvus ICSR for qualifying articles.

01

Multi-database Search

Structured searches across PubMed, Embase, BIOSIS, IPA, and configurable proprietary databases. Search strategies versioned and auditable.

02

AI Relevance Screening

ML classifier assigns relevance scores to every retrieved article. Threshold-based routing: irrelevant articles auto-excluded with sampling; borderline articles queue for human decision.

03

Duplicate Detection

Deduplication across search databases and against the existing ICSR case database — preventing the same case being processed twice.

04

Structured Review Workflow

Articles flow through configurable multi-stage review (abstract → full text → medical assessment). Team assignments, SLAs and workload-balancing supported.

05

Case Conversion

Qualifying articles convert to structured ICSR records in Salvus ICSR with citation, patient/reporter fields pre-populated and article PDF attached.

06

SUSAR / Expedited Identification

Automatic flagging of articles describing serious unexpected reactions in clinical trials with expedited routing and 15-day clock notification.

07

Search Strategy Management

Build, version and compare search strategies per product and jurisdiction. Periodic execution scheduling with drift monitoring.

08

Audit & Evidence Package

Complete audit trail from search through human decisions to case creation — exportable as a GVP VI compliance evidence package.

How it works

From day one to every day after.

A typical journey through Literature Review & Monitoring — from onboarding to steady-state operations.

1

2

3

4

Strategy setup

Import the study definition from EDC; configure validation rules, coding dictionaries and the DMP checklist.

Automated execution

Crypta runs scheduled database searches, retrieves full-text PDFs for qualifying abstracts, and applies AI relevance scoring.

Human review

Reviewers work through the triage queue: irrelevant articles closed with reasons; relevant articles progress to medical assessment.

Case creation

Qualifying articles become ICSR cases in Salvus ICSR. Periodic literature reports (cumulative listing, SPC gap analysis) generated.

See It in Action

Watch Literature Review & Monitoring in action.

A guided walkthrough of the key workflows — built for Pharmacovigilance teams who need to see it to believe it.

.

How to add your demo video

Integrations

Connects where you need it to.

​Clinical Data Management System is designed to work with the rest of the Salvus platform — and with third-party systems your team already uses.

Case creation from qualifying literature

Signum

Literature signals feed signal management

RMP

Literature evidence for safety concerns

Intake

Literature-sourced case routing

Compliant with

GVP Module VI (Rev 2)

CIOMS VI

ICH E2B(R3)

Clinical Data Management System is designed to work with the rest of the Salvus platform — and with third-party systems your team already uses.