Implementation and management of a tailor made pharmacovigilance system in accordance with European legislation and according to quality system, from the management of reports to the implementation of risk minimization measures

 

Safety Management Plan (SMP) Development: monitoring and promotes early issue detection to help mitigate any safety risks in clinical trial subjects and patients.

Clinical Pharmacovigilance (PV) Auditing Services: verifying the appropriateness and effectiveness of the implementation and operation of a PV system, including its quality system.

Individual Case Safety Reports (ICSR) Processing and Submission: identifying, collect, and process Individual Case Safety Reports (ICSRs) in a systematic and robust manner,

Medical Monitoring: Inclusion/exclusion criteria issues, Protocol exemptions and deviations, Medical crisis monitoring for cases involving a study patient, Medication issues

Pharmacovigilance System Master File (PSMF) Development and Maintenance: creating and maintain a PSMF that accurately and comprehensively describes your company’s PV system in line with the legislative format

Risk Management Plan (RMP) Development and Maintenance: guiding you through the process of developing and maintaining a quality RMP that meets all regulatory requirements.