EVM for Pharmaceutical and BioTech: Planning and Managing Contract Research Organizations in an Earned Value Environment

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The College of Performance Management (CPM) has announced the topic and timing for its January Topical Webinar. The webinar will discuss the importance of proper EV management of contract research organizations for clinical trials.

humphreys associates earned value management

The College of Performance Management (CPM) has announced the topic and timing for its January Topical Webinar. The webinar will discuss the importance of proper EV management of contract research organizations for clinical trials, by R. M. “Ric” Brock. It will take place on Thursday, January 23rd at 12:00 p.m. U.S. Eastern Time. The webinar is free to CPM members and $25.00 for non-members. PMI members can earn 1 PDU with the webinar.

Most Pharmaceutical and Biological Technology companies employ Contract Research Organizations (CRO) to manage and conduct clinical trials/studies. How these trials are planned, tracked, and controlled are critical to effective project management regardless of what level of Earned Value requirements are used to manage the contract, whether full ANSI/EIA Standard-748 or the BARDA 7 Principles of Earned Value Management Tier 2 System Implementation. Knowledgeable and expert EV execution is critical. This Webinar will discuss the importance of proper subcontractor planning and management in an Earned Value environment.

The Webinar will address the following topics:

EV flow-down requirements
Planning a clinical trial being conducted by a CRO
Identifying and weighting activities
Time phasing the plan
Change incorporation
Establishing how progress will be tracked for EV determination
Ensuring that EV and Estimated ACWP are recognized in the same accounting period
Forecasting the Estimate To Complete (ETC)

Mr. Brock has been actively developing his skills in program management, operations leadership, and quality assurance in government and commercial environments since 1981. He has extensive experience working with all levels of an organization, from performing personnel to senior leadership, with a focus on continuously improving operating performance and customer satisfaction. He has proven skills in operations leadership, strategic planning, organizational development and team building, quality assurance and management, business development, program management, production and material management, planning and scheduling, schedule analysis, enterprise and manufacturing resource planning systems, and cost estimating systems. Examples of some of the companies he has worked for or supported as a consultant include Olin Corporation, United Technologies, Lockheed Martin, AVCO Aerostructures, Rockwell International, Computer Science Corporation, SAIC, Phillips Petroleum, Louisville Metropolitan Sewer District, Astra Zeneca, Centocor, Shire Pharmaceuticals, Newport News Shipbuilding, Harris Corporation, U.S. Navy, U.S. Army, Raytheon, MRJ Technology, and L3 Communications.

Ric Brock serves as Engagement Director of Humphreys and Associates and has extensive experience supporting Pharmaceutical companies in life cycle management, filing new drug applications, and launching new drugs. As the General Manager of a systems management and manufacturing operation business unit with sales in excess of $100M per year, he was responsible for strategic direction and daily leadership. He has also served as the Director of Operations, Director of Manufacturing, Director of Quality, Director of Management Control Systems, and Program Manager. His achievements while in these roles include the successful acquisition and integration of production assets with existing business units, the transition of a large volume production process to team based agile manufacturing cells, and leading a team that obtained ISO-9000 Quality Management Certification at three separate facilities. He was also responsible for reengineering a production/material control process resulting in a reduction of procurement lead-time by 75%, inventory levels by 30%, and staff by 25% while increasing production through-put by 20%.

Since 1978, Humphreys & Associates, Inc. has advocated and promoted the integration of technical, schedule, and cost components to achieve the full benefit of using a performance measurement system to enhance management visibility and control. They have a long tradition of leadership in the industry and providing a balance of proven and innovative EVMS processes to apply to project management challenges. This is reflected in their commitment to providing exceptional EVMS consulting services and training to every client. Humphreys & Associates

The College of Performance Management (CPM) is an international, non-profit professional organization dedicated to the disciplines of earned value, performance measurement and project management. Headquartered in Alexandria, Virginia, USA, CPM is the world’s leading source of education and information related to earned value management and other performance management techniques. For decades, the CPM Community has been responsible for leading, developing, promulgating and training people on the program management techniques used by the private sector, the U.S. Federal Government and around the world for successful program performance management. CPM is a growing body of professionals dedicated to managing projects on time and on budget. For more information, visit mycpm.org.

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Chris Humphreys