February 2013

For Pharmaceutical Companies

Featured Articles

Peter H. Calcott

The EMA Guidance for Process Validation

by Peter H. Calcott
Calcott Consulting LLC

In February 2012, the Committee for Proprietary Medicinal Products (CPMP) issued the latest version of the new EU Guidance for Process Validation (PV). At the end of October, the opportunity for consultation (comments period) closed, marking the time when the various committees review the comments for inclusion or modification of the document. Sometime in 2013, the formalized document will be issued for use. However, generally, what is presented at this stage is often close to the final version. So a review of the current thinking is very opportune at this time.

As the 21st century continues to drive itself forward, it is becoming clear that the US Food and Drug Administration (FDA) is striving to meet modern challenges. Of especial relevance to executives in industries regulated by the FDA is the immediate impact—for the foreseeable futureā€”of the trends shaping agency action. These actions may include the issuance of guidance documents, inspectional strategies and medicinal product approvals/disapprovals. When considering these potential actions, the business executive has a simple question: Will I, my firm, or our products get caught in the crossfires of change without being prepared?

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Brett Castano

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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Cindy Fazzi

New Report Highlights Need to Reduce R&D Cost

by Cindy Fazzi
Marketing Communications Specialist, MasterControl, Inc.

Most pharmaceutical and biotechnology companies already feel the pressure to reduce their R&D costs. A recent report showing a decline in the ROI for R&D among some of the world's biggest companies is not going to ease the pressure.

A report by Deloitte and Thomson Reuters shows that the average rate of return from R&D in 2012 among the world's top 12 pharmaceutical and biotechnology companies was 7.2 percent-down from 7.7 percent in 2011 and 10.5 percent in 2010.

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