Each year, the process of developing new drugs and new therapies for market becomes more and more complex. A diverse group of stakeholders including sponsors, CROs, regulatory bodies, patients, physicians & hospitals, ethics committees, vendors, etc., each have their own specific needs and requirements which need to be considered. A constantly changing environment with new regulations, new treatment options and competing investigational therapies compounds the issues further.
What Does it Take to Successfully Execute Large, Global, Phase III Programs?
Syneos Health leaders reveal a proven method to thrive in this complex environment
Syneos Health leaders reveal a proven method to thrive in this complex environment
In addition, the complexity of managing a trial goes up exponentially when considering a large global study where geopolitics, differing regulatory requirements, cultural and language differences, variances in standards of care, socioeconomics and much more must be taken into consideration. It’s a challenge many clinical developers face in today’s global marketplace, but one that many times must be undertaken to access the limited patients available to meet enrollment targets.
So, what does it take to successfully execute a program of this nature? Clifford McIntosh, Vice President, Strategic Alliance Management, Syneos Health and Alexandria Wise-Rankovic, Ph.D., Senior Vice President, Clinical Development, CNS, Syneos Health, will break down some of the best practices and crucial elements for executing programs in this challenging environment.
