ICSR Case Management

Overview

Individual Case Safety Reports (ICSRs) are a core component of pharmacovigilance and provide critical information for evaluating the safety profile of medicinal products.

Mediature GxP Solutions Pvt. Ltd. (MGS) supports Marketing Authorization Holders, pharmaceutical companies, CROs, and other life-sciences organizations with end-to-end ICSR case management covering case intake, validity assessment, data entry, coding, quality review, medical review, follow-up, regulatory reporting, case closure, and archival support.

Our approach emphasizes case completeness, medical accuracy, regulatory timelines, data consistency, traceability, quality control, and documented decision-making throughout the case lifecycle.

Our ICSR Services

Case Receipt & Book-In

Support for receipt, acknowledgment, initial triage, date tracking, source identification, duplicate search, and case creation.

Case Validity Assessment

Assessment of the minimum criteria required for a valid safety case, including:

• Identifiable patient
• Identifiable reporter
• Suspect medicinal product
• Adverse event or reaction

Case Processing & Data Entry

Structured entry and review of available clinical, product, reporter, event, treatment, laboratory, and follow-up information into the safety database.

MedDRA Coding

Coding of adverse events, medical history, indications, investigations, and other medical concepts using the applicable MedDRA version.

Drug Coding

Standardized capture and coding of suspect, concomitant, and interacting medicinal products.

Seriousness Assessment

Assessment and documentation of applicable seriousness criteria such as:

• Death
• Life-threatening event
• Hospitalization
• Prolonged hospitalization
• Persistent or significant disability
• Congenital anomaly
• Other medically important condition

Expectedness / Listedness Assessment

Support for assessment of whether reported adverse reactions are consistent with applicable reference safety or product information.

Causality Assessment

Support for company causality assessment based on available clinical information, temporal relationship, dechallenge, rechallenge, alternative causes, and other relevant factors.

Narrative Preparation

Preparation of clear chronological case narratives summarizing the relevant clinical course, treatment, outcome, assessments, and follow-up information.

Quality Review

Independent review of case data, coding, chronology, seriousness, expectedness, causality, narrative, completeness, and regulatory requirements.

Medical Review

Medical review of relevant safety cases to assess clinical coherence, medical coding, seriousness, causality, expectedness, and overall case interpretation.

Follow-Up Management

Identification of missing or clinically important information and preparation of appropriate follow-up queries for reporters or source partners.

Regulatory Safety Reporting

Support for preparation and reporting of applicable ICSRs within required regulatory and contractual timelines.

Case Closure & Archival Support

Final review, completion, lock or closure, and maintenance of retrievable case records in accordance with applicable procedures.

Sources of Safety Cases

MGS can support cases received from sources such as:

• Healthcare professionals
• Consumers and patients
• Medical representatives
• Distributors
• Business partners
• Literature
• Clinical programs
• Patient-support programs
• Market-research programs
• Digital and company channels
• Regulatory authorities
• Product complaints with safety information
• Other spontaneous or solicited sources

Key Case Processing Considerations

Depending on the case, MGS may evaluate:

• Case validity
• Initial versus follow-up status
• Duplicate status
• Patient details
• Reporter details
• Suspect product
• Concomitant medications
• Indication
• Dose and therapy dates
• Adverse event details
• Seriousness
• Severity
• Outcome
• MedDRA coding
• Laboratory findings
• Medical history
• Dechallenge
• Rechallenge
• Causality
• Expectedness
• Listedness
• Pregnancy or breastfeeding exposure
• Special situations
• Follow-up requirements
• Reporting timelines
• Narrative quality
• Data consistency

Our ICSR Workflow

• Receive & Triage

Capture the case, establish the receipt date, assess validity, identify seriousness, and determine processing priority.

• Process

Enter case information, perform coding, assess clinical and regulatory fields, and prepare the case narrative.

• Quality Review

Review the complete case for accuracy, completeness, consistency, and compliance with processing requirements.

• Medical Review

Where required, perform medical evaluation of the case and document relevant medical decisions and rationale.

• Client / PVOIC Review

Where applicable, support the defined client or pharmacovigilance oversight review prior to regulatory reporting.

• Report

Prepare and support submission of reportable cases through the applicable reporting route and format.

• Close & Maintain

Complete follow-up, reconcile reporting information, close or lock the case, and maintain appropriate records for retrieval and audit.

Case Types We Can Support

MGS can support:

• Serious cases
• Non-serious cases
• Initial reports
• Follow-up reports
• Spontaneous reports
• Solicited reports
• Literature cases
• Pregnancy exposure cases
• Breastfeeding exposure cases
• Lack of efficacy cases, where reportable
• Medication error cases
• Overdose
• Misuse
• Abuse
• Off-label use
• Occupational exposure
• Product quality complaints with adverse events
• Other special situations requiring PV assessment

Typical Deliverables

Depending on scope, MGS can provide:

• Booked-in safety cases
• Completed ICSR data entry
• MedDRA coding
• Drug coding
• Case narratives
• Seriousness assessment
• Expectedness / listedness assessment
• Company causality assessment
• Quality-review documentation
• Medical-review support
• Follow-up queries
• Regulatory submission outputs
• Case reconciliation support
• Case closure documentation
• Case processing metrics

Why Choose MGS

End-to-End Case Support

MGS can support the complete case lifecycle from initial receipt through reporting and closure.

Quality-Focused Processing

Our workflow emphasizes accuracy, completeness, coding consistency, traceability, and documented review.

Medical & Regulatory Integration

Case processing can incorporate both clinical assessment and regulatory reporting requirements.

Defined Review Controls

Quality, medical, and client-oversight stages can be incorporated according to the agreed workflow and responsibilities.

Flexible Service Model

MGS can support complete case processing or selected activities such as quality review, medical review, follow-up, or reporting.

Who We Support

MGS can provide ICSR Case Management support for:

• Marketing Authorization Holders
• Pharmaceutical companies
• Biopharmaceutical organizations
• CROs
• Generic-drug companies
• Product-license partners
• Distributors with safety-reporting obligations
• Organizations establishing or expanding PV operations