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Is it Drug Induced Liver Injury (DILI), or something else?

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Governance and Accountability in AI-Enabled Pharmacovigilance

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Soterius appoints Dr. Sumit Verma, MD, DNB to lead operations

Soterius : What does it mean ? When did it begin ?

Soterius appoints its first CEO

Soterius will attend World Drug Safety Congress – Europe

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See More

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Six Things I Keep Coming Back To in Clinical Signalling

Governance and Accountability in AI-Enabled Pharmacovigilance

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World Patient Safety Congress Americas 2026

Streamlining Regulatory Compliance in Multisite Clinical Trials through Automation

Global Literature Surveillance Project

Handling Unexpected High Call Volumes

See More

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Six Things I Keep Coming Back To in Clinical Signalling

Governance and Accountability in AI-Enabled Pharmacovigilance

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World Patient Safety Congress Americas 2026
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Soterius at German Pharmacovigilance Day 2025

Drug Information and Association Conference, Congress Centre Basel, Switzerland

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World Drug Safety Congress- Americas, Boston Convention and Exhibition Centre, Boston, MA

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World Drug Safety Congress – Americas, Boston, Massachusetts, USA

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Clinical SAE Processing & Expedited Reporting

Investigator Brochures Authoring and Updating

Global and Local Medical Literature Monitoring

Signal Detection & Signal Management

Development Safety Update Report (DSUR) Authoring

Reconciliation with Partners, Clinical Database

Responsible Person for Pharmacovigilance (RPPV)

Pharmacovigilance SOPs and Safety System Setup & Maintenance, PSMF, Audits & Inspections

Resources >

Six Things I Keep Coming Back To in Clinical Signalling

Governance and Accountability in AI-Enabled Pharmacovigilance

Events >

World Patient Safety Congress Americas 2026

Postmarketed Pharmacovigilance Services

Case Intake, Processing, Submissions, & Medical Review

Aggregate Reports – PSUR, PBRER, ASR, PADER, Report Calendar Management & Submission

Risk Management Plan (RMP), Risk Minimization & REMs

Global and Local Medical Literature Monitoring

Responsible Person for Pharmacovigilance (RPPV), Qualified Person for Pharmacovigilance & Global Local Safety Support

Pharmacovigilance SOPs and Safety System Setup & Maintenance, PSMF, Audits & Inspections

Resources >

Six Things I Keep Coming Back To in Clinical Signalling

Governance and Accountability in AI-Enabled Pharmacovigilance

Events >

World Patient Safety Congress Americas 2026

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Hosted Drug Safety Database – ArisGlobal LSMV™, LSRA™, ARGUS™ & Veeva Safety™

Global & Local Literature Management Platform – UNITY™ai.Lit

Integrated MICC Platform – Medical Information, Product Complaints & AE Processing

Collaborative Medical Writing with Generative AI Support Platform- UNITY™dx

Safety Case Intake & Case Processing Platform – AnyForm, AnyLanguage & AnySystem

Managed Services, Hosting & Reporting for Drug Safety

Pharmacovigilance Partners Agreements (PVA, SDEA) Management and Case Exchange – UNITY™dx

Clinical Documents Exchange Platform – UNITY™dx

Resources >

Six Things I Keep Coming Back To in Clinical Signalling

Governance and Accountability in AI-Enabled Pharmacovigilance

Events >

World Patient Safety Congress Americas 2026

Medical Affairs and Medical Writing

Multilingual Global Medical Information Call Center

Developing & Managing FAQs and Standard Response Letters

Posters and Abstracts

Resources >

Six Things I Keep Coming Back To in Clinical Signalling

Governance and Accountability in AI-Enabled Pharmacovigilance

Events >

World Patient Safety Congress Americas 2026

Innovation & Technology

Collaborative Medical Writing with Generative AI Support Platform- UNITY™dx

Integrated MICC Platform – Medical Information, Product Complaints & AE Processing

Resources >

Six Things I Keep Coming Back To in Clinical Signalling

Governance and Accountability in AI-Enabled Pharmacovigilance

Events >

World Patient Safety Congress Americas 2026

Insights

Blogs

Six Things I Keep Coming Back To in Clinical Signalling

Governance and Accountability in AI-Enabled Pharmacovigilance

Human Oversight in AI-Enabled Pharmacovigilance: What ‘HITL’ Actually Has to Mean

Deploying an Inspection Ready AI System in PV

Is it Drug Induced Liver Injury (DILI), or something else?

Resources >

Six Things I Keep Coming Back To in Clinical Signalling

Governance and Accountability in AI-Enabled Pharmacovigilance

Events >

World Patient Safety Congress Americas 2026

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Reference Safety Information in Clinical Trials

Resources >

Six Things I Keep Coming Back To in Clinical Signalling

Governance and Accountability in AI-Enabled Pharmacovigilance

Events >

World Patient Safety Congress Americas 2026

News

Soterius appoints Dr. Sumit Verma, MD, DNB to lead operations

Soterius : What does it mean ? When did it begin ?

Soterius appoints its first CEO

Soterius will attend World Drug Safety Congress – Europe

Soterius Expands US Operations

Resources >

Six Things I Keep Coming Back To in Clinical Signalling

Governance and Accountability in AI-Enabled Pharmacovigilance

Events >

World Patient Safety Congress Americas 2026

Case Studies

Streamlining Regulatory Compliance in Multisite Clinical Trials through Automation

Global Literature Surveillance Project

Handling Unexpected High Call Volumes

Resources >

Six Things I Keep Coming Back To in Clinical Signalling

Governance and Accountability in AI-Enabled Pharmacovigilance

Events >

World Patient Safety Congress Americas 2026

Events

Upcoming Meetings & Webinars

Resources >

Six Things I Keep Coming Back To in Clinical Signalling

Governance and Accountability in AI-Enabled Pharmacovigilance

Events >

World Patient Safety Congress Americas 2026

Past Meetings & Webinars

40th Pharmacovigilance UK & EU 2026

World Drug Safety Congress – Boston , Americas 2025

World Drug Safety Congress – Amsterdam, Europe 2025

Soterius at German Pharmacovigilance Day 2025

Drug Information and Association Conference, Congress Centre Basel, Switzerland

Drug Information and Association Conference, Hilton Baltimore Inner Harbor, Baltimore, USA

World Drug Safety Congress- Americas, Boston Convention and Exhibition Centre, Boston, MA

World Drug Safety Congress- Europe, RAI- Amsterdam

World Drug Safety Congress – Americas, Boston, Massachusetts, USA

World Drug Safety Congress, Amsterdam, Europe

Resources >

Six Things I Keep Coming Back To in Clinical Signalling

Governance and Accountability in AI-Enabled Pharmacovigilance

Events >

World Patient Safety Congress Americas 2026

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Six Things I Keep Coming Back To in Clinical Signalling

Governance and Accountability in AI-Enabled Pharmacovigilance

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World Patient Safety Congress Americas 2026

White Papers

Stay updated with expert insights, case studies, in-depth white papers, and the latest thought leadership & innovations in clinical safety, pharmacovigilance & medical affairs.

Soterius • 10 Min Read

Reference Safety Information in Clinical Trials

The Reference Safety Information (RSI) section of an Investigator’s Brochure (IB) is an important document that can be a subject of audits and regulatory inspections. In this post, I have provided guidance for some common questions regarding the RSI. The Reference Safety Information (RSI) section of an Investigator’s Brochure (IB)…

Apr 06, 2022

White Papers

Soterius • 10 Min Read

Reference Safety Information in Clinical Trials

The Reference Safety Information (RSI) section of an Investigator’s Brochure (IB) is an important document that can be a subject…

Apr 06, 2022

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Clinical SAE Processing & Expedited Reporting

Investigator Brochures Authoring and Updating

Medical Review of SAE

Global and Local Medical Literature Monitoring

Medical Monitoring

Signal Detection & Signal Management

Development Safety Update Report (DSUR) Authoring

Reconciliation with Partners, Clinical Database

Responsible Person for Pharmacovigilance (RPPV)

CSR Narratives Authoring

Pharmacovigilance SOPs and Safety System Setup & Maintenance, PSMF, Audits & Inspections

Case Intake, Processing, Submissions, & Medical Review

Aggregate Reports – PSUR, PBRER, ASR, PADER, Report Calendar Management & Submission

Risk Management Plan (RMP), Risk Minimization & REMs

Global and Local Medical Literature Monitoring

Responsible Person for Pharmacovigilance (RPPV), Qualified Person for Pharmacovigilance & Global Local Safety Support

Pharmacovigilance SOPs and Safety System Setup & Maintenance, PSMF, Audits & Inspections

Hosted Drug Safety Database – ArisGlobal LSMV™, LSRA™, ARGUS™ & Veeva Safety™

Global & Local Literature Management Platform – UNITY™ai.Lit

Integrated MICC Platform – Medical Information, Product Complaints & AE Processing

Collaborative Medical Writing with Generative AI Support Platform- UNITY™dx

Safety Case Intake & Case Processing Platform – AnyForm, AnyLanguage & AnySystem

Managed Services, Hosting & Reporting for Drug Safety

Pharmacovigilance Partners Agreements (PVA, SDEA) Management and Case Exchange – UNITY™dx

Validation and CSV Support

Clinical Documents Exchange Platform – UNITY™dx

Multilingual Global Medical Information Call Center

Developing & Managing FAQs and Standard Response Letters

Developing Core Slide Decks

Systematic Literature Review

Posters and Abstracts

Collaborative Medical Writing with Generative AI Support Platform- UNITY™dx

Integrated MICC Platform – Medical Information, Product Complaints & AE Processing

Six Things I Keep Coming Back To in Clinical Signalling

Governance and Accountability in AI-Enabled Pharmacovigilance

Human Oversight in AI-Enabled Pharmacovigilance: What ‘HITL’ Actually Has to Mean

Deploying an Inspection Ready AI System in PV

Is it Drug Induced Liver Injury (DILI), or something else?

Reference Safety Information in Clinical Trials

Soterius appoints Dr. Sumit Verma, MD, DNB to lead operations

Soterius : What does it mean ? When did it begin ?

Soterius appoints its first CEO

Soterius will attend World Drug Safety Congress – Europe

Soterius Expands US Operations

Streamlining Regulatory Compliance in Multisite Clinical Trials through Automation

Global Literature Surveillance Project

Handling Unexpected High Call Volumes

40th Pharmacovigilance UK & EU 2026

World Drug Safety Congress – Boston , Americas 2025

World Drug Safety Congress – Amsterdam, Europe 2025

Soterius at German Pharmacovigilance Day 2025

Drug Information and Association Conference, Congress Centre Basel, Switzerland

Drug Information and Association Conference, Hilton Baltimore Inner Harbor, Baltimore, USA

World Drug Safety Congress- Americas, Boston Convention and Exhibition Centre, Boston, MA

World Drug Safety Congress- Europe, RAI- Amsterdam

World Drug Safety Congress – Americas, Boston, Massachusetts, USA

World Drug Safety Congress, Amsterdam, Europe

Our Global Experts

Contact Us

Careers

Corporate Social Responsibility

Clinical SAE Processing & Expedited Reporting

Investigator Brochures Authoring and Updating

Medical Review of SAE

Global and Local Medical Literature Monitoring

Medical Monitoring

Signal Detection & Signal Management

Development Safety Update Report (DSUR) Authoring

Reconciliation with Partners, Clinical Database

Responsible Person for Pharmacovigilance (RPPV)

CSR Narratives Authoring

Pharmacovigilance SOPs and Safety System Setup & Maintenance, PSMF, Audits & Inspections

Case Intake, Processing, Submissions, & Medical Review

Aggregate Reports – PSUR, PBRER, ASR, PADER, Report Calendar Management & Submission

Risk Management Plan (RMP), Risk Minimization & REMs

Global and Local Medical Literature Monitoring

Responsible Person for Pharmacovigilance (RPPV), Qualified Person for Pharmacovigilance & Global Local Safety Support

Pharmacovigilance SOPs and Safety System Setup & Maintenance, PSMF, Audits & Inspections

Hosted Drug Safety Database – ArisGlobal LSMV™, LSRA™, ARGUS™ & Veeva Safety™

Global & Local Literature Management Platform – UNITY™ai.Lit