Pharmacovigilance

Home Pharmacovigilance

Pharmacovigilance

Welcome to CodeStat Solutions, where Pharmacovigilance excellence meets dedication to safety throughout the entire life cycle of your program.

Our Pharmacovigilance services are designed to ensure that global safety reporting in clinical trials is conducted with precision, timelines are met, and site staff are supported and educated on safety protocols. At CodeStat Solutions, our experienced and highly trained safety team comprises physicians, registered nurses, clinical pharmacists, and medical technologists, each specializing in the collection, evaluation, and submission of safety data in clinical trials. With a focus on concise and rapid exchange of safety information among all stakeholders, our team ensures that your safety profile is managed and analyzed comprehensively.

Partner with our dedicated Pharmacovigilance team to receive regulatory knowledge and expert medical expertise tailored to your specific needs. We offer flexible Pharmacovigilance solutions that can function as an extension of your safety department or as your external Pharmacovigilance team, providing support at the study, program, or company level.

Our comprehensive range of Pharmacovigilance services includes:

  • Evaluation of existing settings, including literature research, reporting, PSURs, and alarm plans
  • Implementation of Pharmacovigilance systems
  • Compilation of Risk Management Plans (RMPs)
  • Tailor-made solutions for your organization, including training and internal audits

At CodeStat Solutions, we are committed to ensuring the safety and well-being of patients throughout the drug development process. Trust us to be your reliable partner in Pharmacovigilance, providing efficient workflows, regulatory compliance, and dedicated support every step of the way.