Advanced Clinical Research and Clinical Trials

Biography

Biography: Nicole Powell

Abstract

Statement of the Problem: Costs and regulatory requirements in our industry are ever increasing and many Sponsors are not aware of how to choose the correct service partner to fit their needs when costs and resources are such a large constraint. Larger CRO’s aren’t inherently set to work with smaller/mid-size Sponsors and therefore don’t have the complete flexibility to create customized solutions to meet the very specific and individualized needs of, for example a virtual Sponsor. Emphasis needs to be placed on statistical consulting from the beginning of the study. Additionally, there are many new technology solutions being pushed upon Sponsors that it is sometimes hard to get past the buzz words and truly evaluate what you need to create an efficient clinical trial.

Methodology & Theoretical Orientation: Sponsors need to decide what existing internal capabilities they have, along with the experience their internal employees bring. They also need to understand the technologies their team is familiar with good and bad experiences and pull from the internal resources they have before exploring partnering options. Once that is established they must look outward to find a partner which shares the same values, service approach and ability to meet their unique needs.

Findings: An increased importance placed on statistics early on in the protocol process can help save time as the trial continues, and can help avoid potential introductory questions by Regulatory Agencies. A chosen partner needs to compliment internal services, have open communication plans put in place and most importantly have long standing relationships with other strategic partners to meet all of the Sponsors needs with less work from the Sponsor. An already established strategic partnership network of specialty providers creates a seamless experience for the Sponsor and a long-standing relationship to develop and execute an efficient trial