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?
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.
The integration with Oracle Health Sciences' suite of industry-leading applications will save organizations significant resources, as documents only have to be checked once early in the process, which will ensure that any issues can be found and corrected in a timely manner enhancing overall quality.
Transforming study startup requires a paradigm shift utilizing both technology and non-technology industry initiatives many of which are currently available to help sites improve operational efficiencies.
Opportunities and challenges lay ahead along the continuum from traditional to hybrid studies, a transition which requires additional infrastructure and associated risks to data protection and patient safety.
Choosing where to conduct a global clinical trial is a critical strategic decision that can impact an entire drug development program. When it comes to planning country selection, Fortuna Eruditis Favet (“fortune favors the prepared mind”).