Journal of Clinical Research & Bioethics

Nicole Powell

3^rd International Conference on Advanced Clinical Research and Clinical Trials

September 20-21, 2017 Dublin, Ireland

Nicole Powell

Statistics and Data Corporation, USA

Scientific Tracks Abstracts: J Clin Res Bioeth

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.

Biography :

Nicole Powell has spent over 12 years in the industry building effective partnerships mostly focused on CRO’s and sponsor relationships. She has a passion for creating specialized experiences for sponsors that enable the clinical trial process to run efficient and smooth. Her ability to combine real world trial experience with the many changes in the industry, over the past decade and beyond, is top notch and provides sponsors with an out of the box solution to create effective trials. Most of her concentration has been focused on evaluating partner relationships, new technologies, and the importance of correct data management and statistical application in trials. She currently plays a pivotal role in the International Business Development and Sales team at Statistics and Data Corporation (SDC) with offices in Boston and Phoenix.