Clinical Trials - Kendall Life Sciences LLC - FDA protocols
Specialized Life Sciences Consulting Group

Clinical Trials
 

Prescription Drug Evolution

How our team can guide you through the entire journey

Clinical Trials

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After obtaining required regulatory approvals, clinical trial work may begin. Clinical trials are generally divided into formal “Phases” each with varying obligations and endpoints. At times, it may become necessary to have formal meetings with the FDA to discuss patient experience or Phase end-points. As more data becomes available, the approved clinical trial protocols may need to be amended in order to obtain necessary data.

The Challenge

Clinical Trial management is subject to strict legal and regulatory requirements and controls. Adherence to these requirements is critical to maximize patient safety and to ensure that clinical trial data can adequately support a future New Drug Application (NDA). Regardless of the strength of the data produced by clinical trials, if such trials are not conducted in accordance with regulatory standards, the results may not be used as part of the future NDA.

The Strategy

Understanding the regulatory scheme is imperative to successful clinical trial outcomes. KLS team of experts help clients navigate this regulatory landscape. KLS understand which obligations must be controlled by the drug sponsor and which may be delegated to third-parties. When delegation is appropriate, KLS understand how to effectively ensure that necessary formalities are in place.

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