The future success of the life science industry in bringing new products to market rests on the ability of sponsors and CROs to work together successfully, providing both parties a compelling incentive to strengthen their partnership with the help of the right structure, tools, and strategies.
Globalization is adding to the complexity of running clinical trials and the pursuit of global trials is increasing. Globalization has an obvious impact on organizational structure of clinical operations teams, but what do the industry metrics have to say about cycle time performance of multi-country vs. single country studies? And economies of scale in clinical trials?
As medical practitioners increasingly seek to provide proactive management for their patients health, new digitally enabled therapies are being developed that consider disease progression and early preventative measures.
Contemporariness is particularity a problem for multi-country studies spanning numerous regulatory agencies. The key challenges arise from not having clearly defined contemporariness in operational SOPs – this has resulted in audit findings.