The Most Important Compliance Best Practices You Need to Know

Pfizer is penalized for violating U.S. racketeering law. The drug giant now, has to pay a hefty amount of $142.1 million for promoting Neurontin for unapproved uses, illegally. In last few months, the world has witnessed many similar cases where the drug making companies are getting more and more involved with illegal or noncompliant means of producing drugs, which often bring these companies into limelight and brought down their reputation. This article highlights the pharma companies that have been under the spotlight for non-compliance so far this year.

This article outlines key aspects of the overall drug development process with focus on the role of nonclinical safety evaluations at each stage of the development and also provides definitions of key terminology used in nonclinical toxicology. Three key decision points are addressed: Drug discovery (focus on lead optimization), nonclinical (or preclinical) safety evaluations prior to first-in-human studies and clinical development and nonclinical studies required for marketing decisions.

Clinical data capture has brought in the use of modern computer front-ends but the back-end processing still lags behind in sophistication. The current processes are very cumbersome, time consuming and non-repeatable.

The solution to warehousing the ever-changing structures of clinical data will require 1) a single, multi-trial repository based upon abstract rather than directly representational data models, and 2) adaptive, meta data-driven ETL programming.

To learn more on the impact of such a transformation by way of simplified validation, elimination of redundant processes and increase revenue by reducing time-to-market read on..