The FDA published its first batch of clinical data summary documents under a transparency pilot program launched earlier this year. …

The study start-up phase sets the tone for a clinical research trial and is crucial to the overall success of a program. The critical nature of this phase places significant pressure on all stakeholders. The strength of the relationship between the site and CRO during study start-up is an important factor in creating a successful study outcome. Rather than a customer and vendor relationship, sites and CROs should strive to develop strategic alliances, partnering seamlessly through an entire clinical study and beyond. The study start-up stage offers ample opportunities for sites and CROs to establish the foundation of a trust-based relationship. …