Worldwide’s tradition of excellence is centered on central nervous system (CNS) therapeutic expertise and in particular in neurodegenerative disorders such as Parkinson’s disease (PD). Our unparalleled research experience in Parkinson’s disease allows us not only to understand the complexities associated with Parkinson’s clinical study design, but also to operationally implement specific design features through the use of innovative strategies and tools that mitigate risks and challenges inherent in this type of study.
Since 2008, we have conducted nine Parkinson’s disease clinical trials in Russia, Ukraine, Romania, Italy and the US. The PD studies encompassed over 1,100 randomized patients across more than 100 sites and the study duration ranged from six to 26 weeks, with most studies being 12 weeks in duration. Therapeutic interventions included different compounds of the class of dopamine D2 receptor agonists.
The range of clinical development services we provided varied from study to study, and included some, if not all, of the following: project management, safety monitoring, clinical monitoring, regulatory services, depot and logistics. In these PD studies, patient enrollment has always met the anticipated metrics in relatively short periods of time, enabling all trials to be completed on time and under budget.