Need end-to-end drug safety support for your clinical or post-marketing journey? We’re here to help
Developing safe and effective drugs or medical devices requires more than innovation — it demands rigorous monitoring and safety analysis at every stage. At Aptitude Solution, we offer comprehensive pharmacovigilance and drug safety consulting services, from preclinical phases through post-marketing surveillance. Our experienced team ensures your products meet all safety standards while supporting compliance with FDA and DEA regulations.
1.
Collect & Document Safety Data
We gather adverse event (AE) and product complaint (PC) reports from all channels — calls, emails, faxes, and field reps — and document them properly.
2.
Analyze & Process Cases
Our experts craft detailed AE narratives, review medical histories, and handle follow-ups, ensuring complete and accurate case files.
3.
Maintain Reporting Systems
We input, update, and manage cases in client databases (e.g., IRMS) and generate weekly/monthly/periodic safety reports as needed.
4.
Ensure Ongoing Compliance
From literature searches to backup support for medical information teams, we help you stay audit-ready and compliant throughout the product lifecycle.
Services we provide
Adverse Event (AE) Case Intake & Narrative Writing
Capture and detail every AE case, complete with timelines, medical history, and event description.
Product Complaint (PC) Management
Intake, follow-up, and documentation of product-related complaints in compliance with client SOPs.
Follow-up Handling
Ongoing communication to ensure case completion and data accuracy.
IRMS & Database Documentation
Skilled use of client systems for complete and accurate case entry and tracking.
Regulatory & Literature Monitoring
Periodic safety literature review and reporting to support compliance and regulatory readiness.
Medical Information Call Center (MICC) Support
Day-to-day assistance with high-volume case management and backup coordination.
