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Ensuring Patient Safety with Comprehensive ICSR Management

Spontaneous reports, literature cases, and regulatory authority submissions require seamless processing to maintain compliance and safeguard public health. Effective Individual Case Safety Report (ICSR) management is critical for identifying potential safety concerns, ensuring timely reporting, and meeting global regulatory requirements.

Alchemy’s End-to-End ICSR Management: Excellence at Every Step

Alchemy provides a complete ICSR management solution, from case intake and data processing to medical review and regulatory submission. Our experienced pharmacovigilance professionals handle all case types, ensuring accuracy, consistency, and compliance with regional and international regulations

End-to-End ISCR Coordination

Ensuring structured safety case reporting with full regulatory alignment.

Rapid Compliance Turnaround

Streamlined workflows for efficient Individual Case Safety Report submissions.

Global Regulatory Familiarity

ISCRs tailored for region-specific compliance (US, EU, APAC).

Data Accuracy & Consistency

Robust validation process to minimize data discrepancies.

Why Choose Alchemy for ICSR Management?

  • Expedited & Periodic Reporting – Expertise in managing both expedited and periodic safety submissions globally.
  • Advanced Automation Tools – Smart systems ensure efficient processing and real-time compliance tracking.
  • Global PV Operations – 24/7 pharmacovigilance support for seamless, uninterrupted monitoring.
  • End-to-End PV Solutions – Comprehensive services covering the full case lifecycle from intake to submission.
3500

ISCRs processed

48

Hour Turnaround

0%
Accuracy Rate
24/7
Case Handling
Testimonials

Voices of Trust

“Alchemy streamlined our entire ISCR process, ensuring 100% compliance with global reporting timelines.”

Auralis Pharma

PV Operations Manager

“Their proactive communication with sites and regulators was instrumental in keeping our studies inspection-ready.”

Nexvita Therapeutics

Clinical Safety Lead

“From triage to submission, Alchemy’s ISCR team delivered exceptional accuracy and responsiveness.”

Veltrix Bio

Pharmacovigilance Specialist

“Thanks to Alchemy, our ISCR metrics improved by over 40% across two major studies.”

Argento Healthcare

PV Compliance Director

Discuss Your Needs with Our Experts

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