What are Medical Review Services?
Our services offer expert review of Individual Case Safety Reports (ICSRs), medical narratives, signal trends, and benefit-risk profiles, ensuring clinical relevance and compliance with global PV standards.
Medical Review for Pharmacovigilance Excellence
Expert Oversight for Accurate Safety Insights
At Indivirtus Healthcare Services Pvt. Ltd., our Medical Review service provides expert evaluation of ICSRs, medical narratives, signal trends, and benefit-risk profiles. Led by qualified healthcare professionals, we ensure scientific accuracy and regulatory compliance for global pharmacovigilance, supporting PSURs/PADERs and safety surveillance.
Why is it Critical?
Medical review ensures patient safety, data accuracy, and regulatory compliance, supporting robust safety surveillance, timely submissions, and informed benefit-risk decisions.
Our Role in Your Success
As a trusted CRO, Indivirtus Healthcare Services delivers expert-led medical review solutions, acting as an extension of your PV team to ensure compliant and accurate safety reporting.
Our Expert Medical Review Approach
At Indivirtus Healthcare Services, our Medical Review services are led by qualified healthcare professionals with global pharmacovigilance expertise. We conduct structured evaluations of ICSRs, medical narratives, signal trends, and benefit-risk profiles, ensuring clinical relevance and regulatory compliance.
Our approach integrates with your PV system, delivering audit-ready documentation that aligns with ICH E2D, GVP Modules VI & IX, and FDA/EMA requirements, supporting timely PSURs/PADERs and safety surveillance.
Medical Review Deliverables
Medically Reviewed ICSRs (CIOMS/MedWatch): Accurate and compliant case evaluations.
Signal Trend Evaluation Reports: Detailed analysis of safety signals.
Benefit-Risk Assessment Documents: Comprehensive safety and efficacy profiles.
Medical Narratives and Case Summaries: Clinically relevant case documentation.
Safety Reporting Dashboards or Annotated Trackers: Tools for real-time safety insights.
Regulatory Compliance & Global Standards
Our Medical Review services align with stringent global pharmacovigilance standards, ensuring your documentation is audit-ready and compliant with international markets. By adhering to industry-leading guidelines, we deliver solutions that enhance safety and regulatory confidence.
- ICH E2D: Guidelines for post-approval safety data management.
- GVP Module VI & IX: European standards for adverse event reporting and signal management.
- US FDA 21 CFR Part 314.80: U.S. regulations for post-marketing safety reporting.
- EMA GVP Guidelines: European standards for pharmacovigilance processes.
Applications & Use Cases
Our Medical Review services are essential for pharmaceutical companies and MAHs managing global pharmacovigilance requirements. Ideal for ICSR processing, signal detection, and benefit-risk assessments, our solutions support regulatory submissions and safety surveillance. Key use cases include reviewing ICSRs for new drugs, supporting PSUR/PADER submissions, and enhancing post-market safety monitoring.
Why Choose Indivirtus Healthcare
Indivirtus Healthcare Services is a trusted partner for pharmaceutical companies, delivering expert-led medical review solutions backed by qualified healthcare professionals with global experience. Our services ensure scientifically defensible outcomes, rapid delivery, and strict confidentiality to protect your proprietary information.
With a commitment to industry best practices, we empower your organization with compliant, accurate, and clinically relevant safety documentation, driving regulatory success and patient safety.
Frequently Asked Questions
Frequently Asked Questions
What qualifications do your medical reviewers have?
Our reviewers are qualified physicians and healthcare professionals with experience in clinical pharmacology and pharmacovigilance. Each case is reviewed with clinical relevance and regulatory insight.
Do you support both spontaneous and solicited case reviews?
Yes, we support both spontaneous (post-marketing) and solicited (clinical trial, patient support programs) case types in full compliance with GVP and ICH standards.
Can you assist with benefit-risk assessment sections of PSUR or PBRER?
Absolutely. We prepare benefit-risk sections using aggregate safety data and literature evaluation for regulatory submission documents like PSURs or PBRERs.
What is the process for signal evaluation and trend analysis?
We combine quantitative data (e.g., disproportionality scores) with clinical assessment to evaluate emerging signals, prepare assessment reports, and advise on next steps per GVP Module IX.
Do you write case narratives from scratch or only edit existing ones?
We offer both options. Our team can create concise, regulatory-compliant narratives or refine and medicalize existing drafts provided by your PV team.
What do Medical Review services include?
Our services include expert review of ICSRs, medical narratives, signal trend evaluations, benefit-risk assessments, and safety reporting dashboards, ensuring PV compliance.
Who benefits from Medical Review services?
Pharmaceutical companies and MAHs managing ICSRs, signal detection, or PSUR/PADER submissions benefit from our expert-led medical review solutions.
How do these services ensure regulatory compliance?
Our services align with ICH E2D, GVP Module VI & IX, US FDA 21 CFR Part 314.80, and EMA GVP Guidelines, ensuring global pharmacovigilance compliance.
What deliverables are provided with the service?
Clients receive reviewed ICSRs, signal trend reports, benefit-risk assessments, medical narratives, and safety reporting dashboards or trackers.
Can the medical review services be customized for our needs?
Yes, our services are tailored to your specific PV requirements, drug products, and submission timelines, ensuring compliant and relevant solutions.
How do the services support PSUR/PADER submissions?
We provide medically reviewed ICSRs, signal evaluations, and benefit-risk assessments to support accurate and compliant PSUR/PADER submissions.