PSI Feasibility Services
form the core of our medical affairs department. In an industry where as many as 85% of clinical trials fall behind schedule due to poor patient enrollment
, PSI delivers refreshing predictability.
Medical Consulting, Monitoring and Training
Clinical trial medical consulting, monitoring and training are part of PSI clinical trials services. The PSI medical experts
provide comprehensive support to investigators and clinical teams, providing consultations and advice on medical aspects of clinical trials.
Individual projects are assigned to experts who understand each protocol. These specialists monitor the medical aspects of the study, advising investigators and project manager’s when required.
PSI operations, medical and project management staff are provided with ongoing training in the latest treatment approaches to a variety of diseases, not to mention treatment standards throughout PSI areas of operation. We are confident that the medical consulting, monitoring and training services provided by PSI can make a genuine difference to the success of your clinical trial.
Pharmacovigilance is an essential aspect of the clinical trial process, and an area in which PSI boasts considerable experience. PSI carries out stringent safety reporting for all clinical trials. Features of our service include 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
Laboratory support services for clinical trials is another key area of medical affairs in which PSI specializes. PSI has a designated team of experts with PhD qualifications in microbiology responsible for interacting with external labs. This group is actively involved in the feasibility logistical process, 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. Clinical trial laboratory support services experts are available globally