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SCRS Resource Guide Network

Sites, Sponsors, CROs: Discover the solutions your clinical research teams need with SCRS.

Stream Line the Budget & Contract Process to Avoid Study Delays

Tuesday, June 10, 2014 12:00pm - 1:00pm EDT  
Host: SCRS Resource Guide Network
By: James M. DiCesare, VP and General Manager, Contract & Regulatory Services, CFS Clinical

Course Description

Starting up a clinical trial is a complex and protracted process with many facets including labor intensive site regulatory document review, contract negotiations, and budget development. Surveys continue to demonstrate this process as the prime cause of study delays. Are you using best practices to streamline the study startup process and reduce the administrative burden on sites and sponsors? Is there a better way? Attend this session and you will learn business processes and technologies that can help shorten the time to FPI.

Learning Objectives

1. Reducing redundancies to speed up site document collection and contract negotiations
2. Ease site burden through smart technologies
3. Improving investigator relationships with efficient business and financial practices

Presenter

James M. DiCesare
James M. DiCesare

VP and General Manager, Contract & Regulatory Services, CFS Clinical

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 collection, review, processing and tracking of essential site regulatory documents as well as the negotiation of clinical trial agreements (CTA’s) and investigator site budgets. Mr. DiCesare has been with CFS since 2006 when he joined the organization as Director of the Pharmaceutical Services Group.

Prior to joining CFS, 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.