Pharmacovigilance and Drug Safety

At ISAPS CRO, we emphasize the importance of pharmacovigilance throughout the drug lifecycle, prioritizing patient safety and quality of life. By adhering to good pharmacovigilance practices, we build confidence among health care professionals and patients globally. Our services are tailored to meet the specific regulatory needs of different markets and partners, adapting to ever-changing requirements. ISAPS CRO ensures continuous monitoring of key performance indicators to achieve regulatory excellence. Choose ISAPS CRO’s customized pharmacovigilance solutions that enhance drug safety and patient confidence worldwide. We Offer comprehensive Solutions.

WE ARE EXPERT AT

Literature Search

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ISAPS CRO conducts comprehensive literature search to identify, evaluate relevant safety information, ensuring compliance with regulatory requirements.

Aggregate Reporting

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We specialize in aggregate reporting, compiling safety data from various sources to provide a comprehensive overview that meet regulatory standards and supports risk assessment.

Signal Management

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Our signal management services involve, identification and evaluation of safety signals, enable proactive risk management and timely responses to potential safety concerns.

Risk Management

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We offer risk management solutions that access and mitigate potential risks associated with drug safety, ensuring compliance with regulatory guidelines and protecting patient safety.

Pharmacovigilance System Master File authoring and updates

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We assist in the authoring and regular updates of the Pharmacovigilance System Master File (PSMF), ensuring that your documentation is accurate and compliance with current regulations.

Case Processing

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ISAPS Case Processing: ISAPS CRO ensure through processing of ICSRs, adhering to global regulatory standards to guarantee the safety and efficacy of pharmaceutical products.

Clinical Trial Case Processing: We provide comprehensive case processing for clinical trials, focusing on the collection, evaluation and reporting of safety data to support regulatory requirements.

Provision of Safety Database

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We Provide robust safety database solutions that support the efficient management and reporting of safety data, enhancing your pharmacovigilance capabilities.

Safety Data Exchange Agreements (SDEA) Management

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Our SDEA Management services facilitate the effective exchange of safety data between parties, ensuring compliance with legal and regulatory requirements.

Qualified Person for Pharmacovigilance Services

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Our QPPV services provide expert oversight and guidance in pharmacovigilance, ensuring that our organization meets all regulatory obligations and maintains high safety standards.

Safety Data Migration Assistance

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Our team offers seamless migration of safety data, ensuring data integrity and continuity during transitions.