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
aspects of Pharmacovigilance for a study or fill in the gaps.
Laboratory Support Services Laboratory Support Services for clinical trials is another key department within PSIs Medical Affairs Division. PSI has a designated team of experts, with PhD qualifications, responsible for interacting with external labs. This group is actively involved in determining logistical feasibility, selecting and pre-qualifying central lab vendors, selecting and managing regional laboratories, and preparing project-specific, lab-related technical operating procedures (TOPs), including those used for shipping biological samples for central assessment. Laboratory Support Services experts work globally.
Medical Writing Services You can depend on PSIs Medical Writing to provide high quality regulatory documents at any point in your product’s development lifecycle – from the clinical development plan to the regulatory submission. Each of our dedicated medical writers has a scientific degree as well as experience in scientific and/or clinical research over a broad range of therapeutic areas. In collaboration with PSIs medical, regulatory and statistical experts, our Department of Medical Writing develops and provides: Clinical Study Reports, Protocols, Investigator Brochures, ICF, Patient Diaries, Safety Narratives, IND/BLA/ANDA, CTA & IMPD, Regulatory submission Support.
WWW.PSI-CRO.COM PSI CRO AG Corporate Headquarters Baarerstrasse 113a, 6300 Zug, Switzerland • Tel: +41 41 228 10 00
Global Office Locations North America: Ft. Washington, PA / Burlingame, CA / San Francisco, CA Latin America: Buenos Aires, Argentina Europe: Oxford, UK / Munich, Germany / Neusiedl am See, Austria Minsk, Belarus / Sofia, Bulgaria / Prague, Czech Republic / Tallinn, Estonia Budapest, Hungary / Milan, Italy / Warsaw, Poland / Bucharest, Romania Belgrade, Serbia / Kiev, Ukraine / Russian Federation: St. Petersburg, Moscow, Novosibirsk
Operational Presence by Region North America / Europe / Latin America Asia-Pacific / South Africa