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World Drug Safety Congress, Europe 2025
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World Drug Safety Congress, Europe 2025

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World Drug Safety Congress, Europe 2025

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World Drug Safety Congress, Europe 2025

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

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

Medication Errors & Patient Safety – Part I

Events >

World Drug Safety Congress, Europe 2025

Streamlining Regulatory Compliance in Multisite Clinical Trials through Automation

Global Literature Surveillance Project

Handling Unexpected High Call Volumes

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

Medication Errors & Patient Safety – Part I

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World Drug Safety Congress, Europe 2025
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Medication Errors & Patient Safety – Part I

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World Drug Safety Congress, Europe 2025

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Drug Information and Association Conference, Congress Centre Basel, Switzerland

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

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Medication Errors & Patient Safety – Part I

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World Drug Safety Congress, Europe 2025
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Clinical Safety Services

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 >

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

Medication Errors & Patient Safety – Part I

Events >

World Drug Safety Congress, Europe 2025

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 >

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

Medication Errors & Patient Safety – Part I

Events >

World Drug Safety Congress, Europe 2025

Innovation & Technology

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 >

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

Medication Errors & Patient Safety – Part I

Events >

World Drug Safety Congress, Europe 2025

Medical Affairs and Medical Writing

Multilingual Global Medical Information Call Center

Developing & Managing FAQs and Standard Response Letters

Posters and Abstracts

Resources >

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

Medication Errors & Patient Safety – Part I

Events >

World Drug Safety Congress, Europe 2025

Innovation & Technology

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

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

Resources >

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

Medication Errors & Patient Safety – Part I

Events >

World Drug Safety Congress, Europe 2025

Insights

Blogs

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

Medication Errors & Patient Safety – Part I

Postmarketing Adverse Drug Experience (PADE) Inspections – Part IV

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Postmarketing Adverse Drug Experience (PADE) Inspections – Part II

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

Medication Errors & Patient Safety – Part I

Events >

World Drug Safety Congress, Europe 2025

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Reference Safety Information in Clinical Trials

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

Medication Errors & Patient Safety – Part I

Events >

World Drug Safety Congress, Europe 2025

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

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

Resources >

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

Medication Errors & Patient Safety – Part I

Events >

World Drug Safety Congress, Europe 2025

Case Studies

Streamlining Regulatory Compliance in Multisite Clinical Trials through Automation

Global Literature Surveillance Project

Handling Unexpected High Call Volumes

Resources >

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

Medication Errors & Patient Safety – Part I

Events >

World Drug Safety Congress, Europe 2025

Events

Upcoming Meetings & Webinars

World Drug Safety Congress, Europe 2025

World Drug Safety Congress, Americas 2025

Resources >

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

Medication Errors & Patient Safety – Part I

Events >

World Drug Safety Congress, Europe 2025

Past Meetings & Webinars

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

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

Medication Errors & Patient Safety – Part I

Events >

World Drug Safety Congress, Europe 2025

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

Medication Errors & Patient Safety – Part I

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World Drug Safety Congress, Europe 2025

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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 of audits and regulatory inspections. In this post, I have…

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

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

Medication Errors & Patient Safety – Part I

Postmarketing Adverse Drug Experience (PADE) Inspections – Part IV

Post marketing Adverse Drug Experience (PADE) Inspections – Part III

Postmarketing Adverse Drug Experience (PADE) Inspections – Part II

Reference Safety Information in Clinical Trials

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

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

Streamlining Regulatory Compliance in Multisite Clinical Trials through Automation

Global Literature Surveillance Project

Handling Unexpected High Call Volumes

World Drug Safety Congress, Europe 2025

World Drug Safety Congress, Americas 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

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