Medical Affairs

PSI’s Medical Affairs Department is a concentration of medical experts involved in a variety of project-specific activities.

Feasibility Services

PSI is distinguished on the marketplace by its consistent ability to deliver timely patient enrollment into clinical trials. This PSI’s strength comes across as particularly valuable and refreshing in the industry where, according to multiple sources, 80 to 90% of clinical trials fall behind schedule due to poor patient enrollment.

One of the key factors contributing to PSI’s patient recruitment success is the company’s determination to invest ample time and MD resource into the assessment of study feasibility.

Several years ago, PSI set up a dedicated feasibility unit staffed with experienced physicians of various therapeutic backgrounds, laboratory experts, imaging specialists, logisticians, and regulatory advisors.

Each project receives a thorough assessment performed by dedicated full-time feasibility staff in order to assess the study feasibility along the lines of its medical feasibility, clinical feasibility, logistical feasibility and regulatory feasibility.

When embarking on a new project we need to be confident that we can deliver it on time, so nothing is left to chance. Our feasibility experts around the world will give your protocol a thorough review and provide recommendations on the choice of sites, countries and realistic timelines.

Please contact us today to discuss feasibility of your clinical trial.

Medical Consulting, Monitoring and Training

PSI’s medical experts are always available to support the investigators and clinical teams with consultations and advice on the medical aspects of the study.  In addition to PSI’s project managers and CRAs in Central/Eastern Europe and Latin America, who all hold medical degrees, specialists in the per-protocol indication are assigned to projects to monitor various medical aspects of the study and to advise both investigators and PSI teams on medical issues whenever there is a need.  Medical Affairs also organizes regular training for PSI clinical employees in the latest treatment approaches to various diseases, as well as current treatment standards across the countries where PSI operates.

Pharmacovigilance

PSI carries out stringent safety reporting for all projects, including a 24/7 safety desk, safety narratives and submissions to the authorities in the countries where PSI operates.  For studies requiring close drug safety monitoring, PSI organizes Data Safety Monitoring Boards (DSMBs), developing a charter, defining membership and organizing and documenting meetings by dedicated medical staff.

Laboratory Support Services

PSI has a designated team of experts with PhD qualifications in microbiology responsible for interacting with external labs.  This group is actively involved in selecting and pre-qualifying central lab vendors, preparing project-specific lab-related technical operating procedures (TOPs), including those used for shipping biological samples for central assessment.

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