Bruce Babbitt, Peter Smith, Marta Jimenez, Parexel

Nov 02, 2007
By Pharmaceutical Executive

CONSULTANTS CAN HELP companies when they need to:

  • Augment resources and expertise for a defined time period or project
  • Improve process performance
  • Implement a risk-management strategy
  • Work with regulators and understand how to comply with new guidelines
  • Access broad knowledge of industry best practices

DRIVE PROCESS PERFORMANCE

In today's highly competitive industry environment, the ways in which business processes are designed and executed have become as important as the innovation of the products themselves. Achieving innovation and effectiveness in operational performance is based on an in-depth knowledge of GxP regulatory requirements and expectations; expertise in business strategy, process, and organizational design; and a belief in the following principles:

  • Efficiency ("doing things right") and effectiveness ("doing the right things") require a well-thought-out, risk-based road map that spans from mastering the basics to achieving operational excellence.
  • Not all companies are created equal. What works for a top pharmaceutical organization may not work for an emerging biotech—and vice versa.
  • Processes, though supported by technology, must not be technology-driven. Reliance on technology alone to detect and analyze signals and/or risk may be misleading and actually increases risk.

IMPLEMENTING A CULTURE OF QUALITY AND SAFETY


Bruce Babbitt
In clinical development good clinical practice requires that quality control be applied to each stage of data-handling to ensure data integrity and to develop and market products that are safe and efficacious. Quality is the responsibility of all persons involved in manufacturing, and a system needs to be in place to manage and control quality with written procedures and standards.

Companies are very much aware of their responsibilities to comply with these requirements. They are also aware of the cost of poor quality and its impact on the company's ability to achieve business goals and objectives. With this in mind, most companies have established quality-control systems and standards (e.g., policies, written procedures, training programs, etc.) that each relevant employee is required to adhere to.


Marta Jimenez
Yet quality does not occur simply because someone has read a policy or a standard operating procedure or attended a training session. Mastering quality and sustaining it consistently over time requires commitment.

A culture of quality is when people's beliefs, behaviors, and the infrastructure that supports them are driven by a shared commitment to do the right things right every time. Having quality at the core of business responsibilities and accountabilities is fundamental to providing safe products to the market.

LEVERAGING GLOBAL CAPABILITIES

Regulation and drug development throughout the world involves a substantial amount of detail. A consultancy's global capabilities and local knowledge acquired in a wide array of geographies is advantageous to the client who does not want to manage a team of independent service providers.

INSIDER INFORMATION

Parexel Consulting is a life sciences consultancy that helps companies design and execute biopharmaceutical and medical-device product strategies through a fusion of scientific, regulatory, and business expertise. It specializes in three main areas: clinical and manufacturing excellence, product development, and regulatory affairs. Parexel Consulting is a division of Parexel International.

Bruce Babbitt, a principal consultant with Parexel Consulting, can be reached at
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Peter Smith (not pictured) is vice president for pharma compliance. He can be reached at