Novella Clinical


Planning for Success: Global Oncology Trials

March 18, 2016

Many pharmaceutical, biotechnology and medical device companies have adopted globalization as a business model for their clinical trials. This model is especially pertinent within oncology with the number of competing trials consistently rising while patient access across North America and Western Europe has plateaued. While this geographic diversity of oncology trial sites has potential to open future markets, it also adds logistical hurdles ranging from import and export licenses to regulatory approval to variances in standard of care. This white paper explores several of the areas critical to the success of global oncology trials, including study planning, conducting feasibility and navigating regulatory submissions.