A top three pharmaceutical company was seeking a partner to address challenges establishing and maintaining timelines for new studies and meeting submission deadlines to regulatory bodies
Lack of available internal resources with the required statistical programming knowledge to use across all therapeutic areas, especially in oncology.
Features of Engagement:
Ephicacy was selected as a partner for the global support of Biostatistics and Statistical Programming to provide a low-cost solution which would lead to improved data quality and data analysis leading to successful submissions.
Within 12 months of contract agreement, Ephicacy provided more than 50 resources to this sponsor’s studies, and continuing to reach the target value of 100 consultants in stats and programming in another 6 months.
Ephicacy teams supported the sponsor’s teams in both India and the United States for both individual statistical programming study level support and higher-level overarching programming and statistical consultancy.
Ephicacy initially supplied resources from the US and as the relationship grew due to the high quality of work, India and Ephicacy gradually increased the proportion of India based resources with a current ratio of US:India at 1:2
As the partnership matured, a better understanding of sponsor systems and processes was gained.
Identification of cross-study redundancy and the degree of standardization across studies allocated to Ephicacy was assessed to allow for efficiency in programming and statistical modelling.