Proactive ADR Detection and Regulatory Compliance
At Indivirtus Healthcare Services Pvt. Ltd., our Literature Monitoring service ensures GVP-compliant screening of global and local databases like Embase and PubMed for adverse drug reactions (ADRs), signals, and safety concerns. We deliver traceable, submission-ready outputs to support regulatory compliance and pharmacovigilance.
Our services screen global and local literature databases to identify ADRs, safety concerns, and signals, providing case intake, data abstraction, and submission-ready outputs aligned with GVP Module VI requirements.
Proactive literature monitoring ensures patient safety, timely ADR detection, and regulatory compliance, supporting robust pharmacovigilance and submission readiness.
As a trusted CRO, Indivirtus Healthcare Services delivers expert-led literature monitoring, ensuring compliant, traceable, and timely detection of safety signals for regulatory submissions.
At Indivirtus Healthcare Services, our Literature Monitoring services are led by qualified pharmacovigilance professionals specializing in global safety compliance. We screen databases like Embase and PubMed, perform structured data abstraction, draft narratives, and prepare submission-ready outputs.
Our approach uses structured workflows and rigorous review processes, ensuring compliant and traceable documentation that aligns with GVP Module VI, ICH E2D, and EMA standards for pharmacovigilance.
Literature Search Log and Documentation: Comprehensive records of screening activities.
ADR Case Identification Reports: Detailed reports of identified adverse drug reactions.
Signal Detection Summaries: Analysis of emerging safety signals.
Narrative-Ready Case Outputs: Prepared narratives for regulatory reporting.
Submission-Ready Case Forms or Line Listings: Compliant outputs for regulatory authorities.
Our Literature Monitoring 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.
Our Literature Monitoring services are essential for pharmaceutical companies and MAHs ensuring proactive safety monitoring. Ideal for ADR detection, signal identification, and regulatory submissions, our solutions support global pharmacovigilance requirements. Key use cases include monitoring literature for new drug products, supporting PSUR submissions, and identifying emerging safety signals.
Indivirtus Healthcare Services is a trusted partner for pharmaceutical companies, delivering expert-led literature monitoring solutions backed by certified pharmacovigilance 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, traceable, and timely safety monitoring, driving regulatory success and patient safety.
Screening frequency is typically weekly or monthly, depending on your regulatory obligations. We can adjust the cadence to align with your product portfolio and compliance needs.
Yes. We screen global databases like PubMed and Embase, as well as region-specific or language-specific journals, to ensure full compliance with EMA and local authority expectations.
Absolutely. We provide narrative-ready outputs or direct case entries in formats like CIOMS or MedWatch, ready for submission or integration into your safety database.
Yes, we flag and analyze potential safety signals emerging from literature and prepare structured signal assessment reports based on GVP Module IX.
We can export outputs in formats compatible with safety databases like Argus, ArisG, or Veeva Vault Safety, and integrate with your internal workflows as needed.
Our services include screening Embase/PubMed for ADRs, signal identification, data abstraction, narrative drafting, and submission-ready case forms, aligned with GVP Module VI.
Pharmaceutical companies and MAHs monitoring ADRs, signals, or preparing regulatory submissions benefit from our proactive, compliant solutions.
Our services align with GVP Module VI, ICH E2D, EMA Good Vigilance Practices, and WHO Pharmacovigilance Guidelines, ensuring global compliance.
Clients receive literature search logs, ADR case reports, signal detection summaries, narrative-ready outputs, and submission-ready case forms or line listings.
Yes, our services are tailored to your specific drug products, monitoring needs, and regulatory requirements, ensuring compliant and effective solutions.
We provide submission-ready case forms, line listings, and narratives to support PSURs and other regulatory submissions, ensuring timely and compliant reporting.