All studies are driven by patient safety as a priority. With over 54,000 patients recruited into our projects since 2005, we place high importance on introducing patient centricity principles into every stage of a trial. With that in mind, the Palleos Pharmacovigilance and Medical monitoring teams cover a range of safety tasks and responsibilities in the course of a study.
Prioritizing patient safety, we meticulously manage adverse events, adhering to all regulatory standards. Our flexible safety processes tailor communication of patient safety data to sponsor needs. Our comprehensive Safety & Pharmacovigilance services encompass safety management plans, MedDRA coding expertise, case management, and safety oversight, including Phase I SRC review and ICSR processing (Phase I-IV, including NIS). We provide medical assessment of ICSRs, regulatory reporting, electronic safety reporting, medical review of subject data, DSUR preparation, tabulated safety data for DSMBs/MAHs, and post-marketing surveillance. Experience with eDrug Safety solutions (e.g., VigilanceONE, PcVmanger) is also available.
Palleos Medical Monitoring Services encompass medical surveillance of your trials by experienced clinicians to ensure patient safety and signal detection/interpretation. The Medical Monitoring service also comprises quality control and approval of your trial documents in order to comply with the ethical standards and regulatory requirements for clinical research. Futhermore, our medical experts provide training on specific medical topics.
“Drug development is a costly and time-consuming process. Therefore, it is vital to obtain all-encompassing information on drug safety to ensure its speedy marketing authorization and prevention of unfavorable outcomes.”
Managing Director
