MEDICAL AFFAIRS PSIs Medical Affairs Division works flexibly as you, the sponsor, define your specific needs. We work according to your SOPs, PSIs SOP’s or a customized version for the study. Your personal PSI medical team lead will prepare a Medical Monitoring Plan and/or a Safety Management Plan to give explicit, detailed instructions for study-specific medical monitoring and safety reporting processes. The Plan will be illustrated by workflow diagrams and step-by-step descriptions. The plans also detail communication lines and escalation pathways. PSIs Medical Monitoring Department is comprised of board certified physicians who work closely with your project team to provide a range of medical support services. We employ physicians, located in the America’s and across Continental Europe, who have clinical research experience and who understand each protocol and the challenges it poses. The Medical Monitor can assume any of the following responsibilities: Clinical development program consulting/KOL networking Medical and scientific support for regulatory submission planning and preparation Therapeutic area training and protocol training Pharmacovigilance support Prospective patient eligibility review/Analysis of Screen Failures Medical data review/Medical Coding/Laboratory data review Medical decisions regarding protocol compliance DMC and DSMB member selection, charter preparation, contracts, meeting preparation and management
Pharmacovigilance (Safety Reporting) Safety Reporting is a combined effort of the Pharmacovigilance safety officer, the medical monitor and the regulatory officer. PSIs Pharmacovigilance Department includes a Safety Desk that employs safety desk coordinators located in different time zones; North/South America and Europe. Our service features dedicated, toll-free safety lines in more than 40 countries, ensuring receipt of safety-related information 24/7, from any corner of the world. Depending upon the sponsor’s plan for managing SAEs/SUSARS, PSI can manage all