By Joseph Arcangelo, inSeption Group
There seems to be a conventional wisdom stating a Phase III study should be handled by a large CRO. After all, large CROs generally have the resources on-hand to staff such a study within the sponsor’s ambitious timeline. In fact, while this model might be advantageous for expansive studies in non-critical indications, it usually fails to meet the personnel needs of sponsors executing Phase III studies in critical indications, ranging from oncology and neurological disorders to development of orphan drugs.
Understanding the pros and cons when deciding between a large CRO and a more niche partner requires an examination of all factors affecting scale-up to a Phase III study: therapeutic area, the dynamics of business operations between large and small organizations, how such organizations scale up employee numbers, and more.