Best Practices for Managing Clinical Trials Materials

Best Practices for Managing Clinical Trial Materials - Webinar CD/Transcript

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It's a fact: A whopping 85% of sponsors fail to deliver their clinical trial materials on time and complete.

And a recent survey revealed that over 75% of sponsors say their clinical trial materials supply chain is “ineffective.”

Is your organization one of those falling short?  If so, here's how to begin solving your problem.

With clinical trial sites increasingly scattered around the globe, supply planning and distribution can make or break a study.

Investigational products must be manufactured, stored and distributed in strict accordance with Good Manufacturing Practices, utilizing labeling and packaging that match the trial protocol.

But only effective master planning can ensure that deliveries of those products will not be not delayed at the risk of the inventory expiring.

Sponsors are well aware of the examples of catastrophic failures in managing clinical trial materials. A 2010 earthquake in Chile destroyed thousands of frozen samples for clinical trials … Hurricane Katrina destroyed virtually all clinical trial materials at Tulane and Louisiana State University in 2005 … floods in Iowa in 2008 wiped out more than $200,000 worth of clinical trial facilities and materials.

But skipping even the simplest day-to-day best practices can derail a trial, such as overlooking expiry dates on existing stock, storing materials at improper temperatures  in customs warehouses, and making last-minute deliveries to the wrong address.

Today, sponsors simply cannot afford such errors. In this webinar, a leading clinical trial materials and supply chain expert will provide proven best practices to improve your company's forecasting of clinical trial materials needs, teach you what FDA and international regulatory authorities require and provide tips for managing catastrophes.

You will learn:

  • How to develop a robust, compliant supply based on proven master planning that focuses on dependent and independent demand forecasting.
  • The secrets to leveraging master planning to control key planning stage elements: Patient recruitment, expiration dating of supply and integration across all manufacturing steps. Metrics will be identified and explained that will help you create an accurate Demand Calculation program to ensure enough product is developed and shipped at the right times.
  • Ways to identify the most serious production threats to a strong materials program, including shortening of expiration dates due to lack of long-term stability data, the necessity to package small product lots with placebos in the same packaging, and the need to package and track small product lots.
  • How master planning will make it possible to generate and control accurate records and master files.
  • Tips for handling catastrophic events.
  • The latest FDA and EU materials requirements — and proven compliance tools.

With the high cost and strict handling requirements for products entering clinical development, the logistics of clinical trial supplies are clearly more critical than ever.  Firms conducting or relying on clinical trials have begun to realize that an effective materials process, based on effective processes and sound principles, are the foundation of a successful trial.

The Best Practices for Managing Clinical Trial Materials webinar  CD and transcript will help you see that an effective materials process, based on effective and sound principles, can become the foundation for a successful trial. Order your webinar CD and transcript today.

  • Drug manufacturers
  • Biologics manufacturers
  • Combination products manufacturers
  • CROs
  • Clinical trial sites
  • Distribution vendors

Hedley Rees is a member of the Steering Committee of the Advanced Manufacturing Supply Chain Initiative at Oxford BioMedica.  Currently the Managing Consultant at Pharma Flow specializing in international supply and trial issues, Rees has also held senior positions at Bayer UK, British Biotech, Vernalis, Ortho-Clinical Diagnostics, and OSI Pharmaceuticals. Rees is the author of the acclaimed book "Supply Chain Management in the Drug Industry."