In today’s world, planning a clinical study is akin to the building of an infrastructure for a new nation. There are so many pitfalls and hurdles and requirements that for the small startup company, it can feel like the most daunting project in the world.
ISO 14155:2016 is an international and FDA consensus standard and true guide for anyone implementing a study, large or small. What is not in the standard can only be gained from experience. How do we choose our PI? What do we look for in our contract negotiations? What is the role of the biostatistician? How should the study be monitored? Have we chosen the right PI for this study stage? This presentation will provide tips for specific aspects that are often overlooked and result in time consuming extra work, loss of money (going over budget) and even failure to meet objectives within the study. This presentation will relate to Medical Device Studies; however, the main points are equivalent for both biologics and pharmaceuticals.