April 2013

For Blood & Biologics Companies

Introduction to High Risk Software Automated Testing

by: Brett Castano, Clinical Operations Manager, RealityCorp

In today's world, high risk software applications are managing a majority of clinical trial data collected in the field. In the early 2000s, the clinical trial industry saw a switch from managing the data collection process through manual means to doctors utilizing secure software applications that allow the doctor to enter the data electronically through the use of a computer or mobile device. MasterControl itself is an example of a high risk software system that is utilized within the clinical trial industry, as it is focused on creating and regulating the process by which clinical trial documentation is managed. In this article, applications created by vendors (such as MasterControl) that will be utilized by doctors or other managers in the field to aide and assist in the management of clinical trials will be referred to as eClinical software, while the collective group of software providers comprise the eClinical industry (http://en.wikipedia.org/wiki/EClinical_trial_technology/).

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Five CAPA Tips that Help Ensure Compliance

by Seth A. Mailhot, Special Counsel, and Emily Theriault, Associate, Sheppard Mullin Richter & Hampton LLP

Having been intimately involved in how the U.S. Food and Drug Administration ("FDA") inspects current Good Manufacturing Practice ("cGMP") requirements for nearly two decades, I find myself repeating certain things to companies. Most often, the issues I repeat relate to Corrective and Preventive Action ("CAPA") systems. CAPA systems are a focal point in FDA inspections precisely because they are the process that manufacturers follow in case something goes wrong. In the same way that a person's character may be understood by trial through adversity, quality system auditors and FDA investigators understand a company's operations through its CAPA system.

A CAPA system is not only a regulatory mandate, it is the means by which a company may improve its quality system to minimize risks and avoid problems. A properly designed CAPA system provides a process by which a company can proactively and retroactively correct problems identified through the quality system. This requires a robust dataset to detect problems, a measured approach to finding solutions, a careful implementation of those solutions, and documentation to memorialize and communicate the changes made to others.

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Clinical Research: Common Challenges in Sponsor-CRO Relationship

by: Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

Outsourcing thrives in good times and bad. Life science companies rely on contract research organizations to complement in-house work in times of growth and expansion, but they also rely on CROs to reduce costs in times of financial downturn.

This is especially true with pharmaceutical companies that sponsor clinical trials. Over the past decade, the annual growth for drug sponsor spending for CRO services has outpaced annual increases in global spending in new drug development, 13.4 percent versus 9.1 percent, according to a 2010 research by the Tufts Center for the Study of Drug Development.

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