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May 2010

How Will Personalized Medicine Have an Impact on Clinical Trials?

Abel Ureta-Vidal

How can genomics have an impact on the management of your clinical trials? With the growing understanding of genetic code within personalised medicine, could this signal a change in the size and scope of clinical trials? What does this mean for the pharma industry and the patient? Personalised medicine is a current buzz word but what does it actually mean? Some say it has the potential to affect the entire landscape of our healthcare system - over the next ten to 20 years.

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Top Five GCP Violations in a Clinical Study

Michelle Sceppa

Clinical trials are conducted to allow safety and efficacy data to be collected for health interventions (e.g., drugs, biologics, devices, therapy protocols). These trials can only take place once satisfactory information has been gathered on the quality of the non-clinical safety. The regulations that provide a platform for the quality of the data are Good Clinical Practices or GCPs.

A significant portion of FDA regulations/requirements and Industry Guidelines pertain to Good Clinical Practices (GCPs). That being said, what are the basic principles of these regulations as they pertain to clinical trials? Good Clinical Practices provide a unified standard for the conduct of clinical trials.

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How Auditing Supports Supply Chain Management

Dennis Arter

One of the fundamental rules of auditing is to measure and evaluate against requirements. While requirements come from multiple sources in an internal and registration audit, for supplier audits these requirements always come from the contract. (Contracts come in a number of different forms, such as purchase orders, letter agreements, etc.) Three things need to be considered, when writing a supplier contract: technical requirements, accept-reject criteria and/or management system requirements.

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Did you know that supplier evaluations differ from audits in scope, requirements? EduQuest, a global team of compliance experts, recently answered a query regarding supplier evaluations and audits. You might find this to be of interest to your company as well!
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