Throughout the life cycle of the program, Product Safety ensures timelines are met in global safety reporting in clinical trials, supports and educates site staff, and provides a safety profile through management and analysis of the safety data as part of their Pharmacovigilance services. Our experienced, highly trained safety team is composed of physicians, registered nurses, clinical pharmacists, and medical technologists. These safety and surveillance experts specialize in the collection, evaluation, and submission of safety data in clinical trials. The cornerstone of all of the Product Safety services is the concise and rapid exchange of safety information among all parties.

The Sainalytics Pharmacovigilance team offers the regulatory knowledge and dedicated medical expertise to provide you with a flexible Pharmacovigilance solution tailored to your needs. Sainalytics proposes an organizational structure that ensures the most efficient work-flow and processes.

Sainalytics Pharmacovigilance can work as an extended arm to your safety department, or as your external Pharmacovigilance team, on a study, program or company level, offering the following services for Investigational Medicinal Products and Medicinal Devices, both during clinical development and post-authorization.

Our product safety team also provides:

  • Evaluation of the existing setting (literature research, reporting, PSURs, alarm plans, etc.),
  • Implementation of PV systems,
  • Compilations of Risk Management Plans (RMPs),
  • Tailor-made solutions for your organization-training and internal audits, etc.