Finding qualified investigator sites who can deliver patients is always a challenge, but these recruitment challenges are amplified when the study has started and teams find themselves behind with their enrollment projections. As the project goes into “rescue mode” study teams must not only find additional sites, but also engage with them to activate them quickly.
Join the presenters to hear the results of one such S.O.S. – a case study where a sponsor found sites in a highly competitive therapeutic area, with a number of competing ongoing studies, and successfully rescued their study. They will also discuss how combining a technology-enabled solution with the knowledge of industry experts provides the best solution for identifying appropriate sites, engaging with them and activating them efficiently.
- Understand how to use technology to ‘pre-qualify’ sites ahead of a site visit, and minimise burdens on the site
- Describe the benefits of sharing as much information as possible with investigators during site identification
- Discover industry best practices that can both automate and expedite several key steps in the site activation process
- Learn how to harness the power of your existing site data and documents to shorten activation in a rescue situation
William Turnbull, Local Study Leader, AstraZeneca
As a CRA for AstraZeneca, Mr. Turnbull is involved with trials from study concept through database lock and study close-out activities. His primary responsibility is to monitor the progress of the clinical sites participating in studies to assure protocol is followed and the data is reported accurately and in a timely fashion. He is also keenly involved with feasibility, study startup, budgeting and contracting of studies working with data management teams, CRO’s, sites, and other third parties to identify and resolve operational issues to keep studies moving forward.
Bill has been with AstraZeneca for 15 years and prior to that worked as a scientist for DuPont Pharmaceuticals and Quest Pharmaceuticals. He has a B.S. in Biology from Saint Joseph’s University.
Kirsty Kwiatkowski, Director, Feasibility and Site Identification, DrugDev
Site Services Director Kirsty Kwiatkowski oversees the DrugDev Investigator Network and all Site Services projects. Kirsty is passionate about clinical trials research and influencing the evolution of the clinical trials process. She is a stealth organizer (organizing people without them knowing it!) and brings to DrugDev many years of clinical and regulatory operations experience.
Kirsty’s pre-DrugDev career was spent managing clinical trials and teams of clinical trialists at Vernalis, Johnson & Johnson and Pharm-Olam, working across all phases of clinical research and several therapeutic areas. Kirsty completed her biochemistry degree at York University.
Jim DiCesare, Vice President, Contracting & Regulatory Services, DrugDev
Mr. DiCesare leads a highly skilled and experienced team of individuals who are responsible for delivering study startup services to clinical trial sponsors and CROs. This includes both the collecting, reviewing, processing and tracking of essential site regulatory documents as well as negotiating clinical trial agreements (CTA’s) and developing investigator site budgets. Mr. DiCesare joined CFS in 2006 as Director of the Pharmaceutical Services Group and advanced quickly to his current position. CFS Clinical was acquired by DrugDev in 2013.
Earlier in his career, Mr. DiCesare spent 14 years in the financial services and Pharmaceutical industries. Most recently, he spent more than 9 years at Merck & Co., Inc., providing clinical trial financial management and commercial outsourcing services in support of the Clinical Development Programs Department. He held positions of increasing responsibility while at Merck, culminating in the position of Senior Manager of Financial Operations. Prior to Merck, Mr. DiCesare spent 5 years in the financial services industry where he held various senior-level positions within the internal audit departments of Harleysville National Corporation and PNC Bank Corporation.
Mr. DiCesare has a B.S. in Accounting from Kutztown University in Kutztown, PA.
Who Should Attend?
Senior level executives involved in clinical operations management for pharma, biotech companies or CROs.
DrugDev simplifies life at the clinical trial site through technology and services that enable sponsors, CROs and investigators to do more trials together. By providing study startup solutions, global payments by CFS Clinical, and a clinical trial optimization platform by TrialNetworks, DrugDev creates and drives standards to improve quality, shorten timelines and reduce cost. In addition, DrugDev maintains the industry’s largest global network of opt-in sites actively seeking new trial opportunities, and serves as the third-party host of the pre-competitive Investigator Databank sponsored by Novartis, Janssen, Merck, Lilly and Pfizer. Learn more at http://www.drugdev.com/