The Future Of Outsourcing In Clinical Research – Preparing For A Changing Global Landscape



The Future Of Outsourcing In Clinical Research – Preparing For A Changing Global Landscape

Date: December 7, 2016
Time: 1:00pm-2:30pm, EST US
Duration: 90-Minutes
Price: $299 – Includes Bonus Handouts!
Course Description:

Clinical studies over the last decade have shifted towards a model involving both on-site and off-site resources, plus internal and external personnel. We, as an industry, are now at a point where the majority of clinical research projects are now handled by Contract Research Organizations, also known as CROs. Once in the hands of the CRO, the projects are often plagued with challenges that seem insurmountable, including increased operational costs, longer duration of clinical trials, competition for productive clinical trial sites, and reduced or stagnant internal staff. Additionally, the pharmaceutical industry traditionally has a history of low operational efficiency, which is complicated by the movement to establish more vigorous control over healthcare costs by governments worldwide.

This course will examine some of the operational changes with regard to global outsourcing that the pharmaceutical industry must make if the expectation is to remain efficient and competitive in the drug development business, all while putting the patient first.

This 90-minute interactive online course will examine the “pros and cons” of outsourcing in the clinical research space, as well as how to develop a modified model to keep pace with our changing environment. Topics to be discussed include:

Common mistakes made when selecting CRO partners, and the mistakes made after project launch
Ways to ensure your relationship with the CRO remains efficient, productive, and focuses on patient outcomes
A look at the future of the outsourced model in clinical research – how to best prepare for tomorrow

Who Should Attend

This course will be of greatest benefit to:

Anyone involved in outsourcing clinical operational tasks to a CRO
Sponsor and vendor personnel at an operational level
Individuals tasked with managing and or interacting with a CRO
Clinical research study monitors, CRAs, and QA Auditors

Instructor Bio
For over 10 years, Michael Pierro has provided consulting services to the Biotechnology, CRO and Pharmaceutical Industry in the areas of clinical operations (Standard Operating Procedures, Project Management and Clinical QA GCP auditing) and GCP/SOP training (live & Internet delivery). In this work, he draws on over 30 years of experience in clinical operations and training in the pharmaceutical & biotechnology industry.

Previously employed by Barnett International, Michael served as Director, Business Development: Consulting & Clinical Training responsible for development and implementation of GCP related standard operating procedures, specialized compliance related training programs and related consulting services. Clients include Pharmaceutical, Biotechnology, CROs, University Medical Centers and US Federal Government.

Immediately prior to joining Barnett, Michael was Director of Global Training for Hoechst Marion Roussel’s (Aventis) Global Clinical Quality Assurance Department. In this role, he directed all GCP Auditing, SOP and technical training programs and activities within the company’s Global Drug Development Center and other development sites throughout the world. In previous roles with Hoechst Marion Roussel and other major pharmaceutical companies, Michael served as a Senior CRA, Manager of Phase IV Clinical Operations and Chairperson of the SOP Steering Committee and GCP Auditor. He was involved in several NDA and SNDA preparations and filings as well as other reports to the regulatory agencies.

Ad Reference ID: 392582a13d40081c

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