Pharmacovigilance

Pharmacovigilance

Patient safety is critical not only during product development but also for marketed products.

Bones Medical supports successful pre-approval and post-market pharmacovigilance (PV) and Medical Information (MI) expertise for pharmaceutical drugs (brand and generic), biologics, radiopharmaceutical drugs, natural health products, and medical devices.

Pharmacovigilance, or drug safety, is crucial to understanding a drug, biologic or combination product’s risk-benefit profile and protecting the welfare of patients by systematically detecting and assessing adverse events.

Our experienced experts deliver pharmacovigilance services at all levels, including specialists, senior consultants, strategists, and safety physicians.

Medical monitors work closely with the sponsor and sites to perform qualified medical reviews of e.g., SAEs/SUSARs as well as providing general oversight and immediate support when safety issues arise. At Bones Medical, we understand that when it comes to safety, what we do is as important as how we do it, and in addition to regulatory compliance, we believe that clear communication, efficient reporting procedures, and seamless collaboration are essential for success.

Our services include

The following areas are covered by our quality management system, which guarantees the excellent quality of work delivered by Bones Medical:

• Literature surveillance
• Individual case management including follow up and submission to competent authorities
• Investigator’s Brochure updates
• Secure storage of cases in a validate database
• Risk/benefit assessment for your product
• Case narrative preparation
• Medical writing for DSURs and PSURs

Whether you are looking to partner for case processing support, aggregate safety reports, literature searching, medical assessment, or for an end-to-end product portfolio maintenance program, we adapt our solutions to meet your unique needs.