Selecting & Managing CRO's Training Course :

Who Should Attend
Learning Objectives
Description
The content of this course will assist pharmaceutical and biotechnology researchers and managers and their counterparts in the CRO industry in understanding the requirements for a well-designed and successful outsourcing program that is completed on time, within budget, and in compliance with FDA regulations and ICH guidelines. The types of CROs and the various outsourcing requirements will be presented to assist in designing the sponsor-generated outsourcing program. Proposal solicitation and evaluation, site visits, contract negotiations, and other items necessary for identifying and selecting a CRO will be discussed. Research study planning, monitoring, problem assessment and correction, and other areas involved in successfully managing a CRO will be presented. FDA views and legal obligations of CROs and sponsors, including generation and review of study reports submitted in INDs and NDAs, will be detailed. Emphasis will be given to the overall management of CROs; how to resolve issues of monitoring, timeline lags, and effective communication.
01/01/0001 To 01/01/0001
Training Company
The Center for Professional Advancement (CfPA)
Industry
Clinical Research Organization
Course Category
Address
New Brunswick, NJ New Brunswick,