Pharmacovigilance
Clinexa utilizes industry-leading PV systems for delivering full range of PV solutions. We offer a broad range of expertise for supporting the safety oversight of marketed products including supporting safety oversight for clinical trials. Our PV team provides has expertise in preparing and reviewing pharmacovigilance documents. Other services that we provide include but are not limited to:
– Safety narratives
– Coding for AEs, SAEs, medications and medical history
– Causality and seriousness assessment
– Advisory services for pharmacovigilance
– PSURs & DSURs