PEDIATRIC PSI brings a wide-ranging depth of expertise to the conduct of studies in pediatric populations. PSI has completed numerous such trials in a variety of indications, across all pediatric age groups and world geographies. We include our pediatricians, who focus primarily on pediatric programs, in both our operational and medical teams. PSI’s separate Feasibility Department, comprised of medical specialists, laboratory experts, imaging specialists, logisticians and regulatory experts, has conducted feasibility across a wide range of pediatric diseases. When we apply this process to your trial and combine it with our knowledge of the nuances and complexities associated with pediatric trials, we are able to provide recommendations for the best geography and sites that will align with the timeline you desire. Support personnel for any pediatric study at PSI include medical monitors, statisticians, regulatory officers, data managers, logistical experts and quality assurance. With a staff turnover rate of <6%, chances are good that noted team members have worked on a large number of pediatric studies. This experience enables PSI to use not only historical data but informs our knowledge of current practices. We apply our understanding to prepare for and overcome key challenges during the regulatory process and approval for all pediatric studies. We have all the means to ensure that a team of experts will run … It will be a great pleasure and privilege to cooperate with the PSI team again with a goal to achieve the most successful results in our pediatric study, based upon your past and current history of very productive collaboration with [sponsor].
your study. Our clients know that difficult studies are what PSI does best.
For more information about PSI, please visit our website WWW.PSI-CRO.COM or reach us at CONTACT@PSI-CRO.COM
Senior Project Manager, Switzerland