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25 Reasons Why Pharmaceutical Companies Need a Unified Clinical Trial Management Platform

Cloudbyz

Clinical trials are the backbone of drug development, and managing these trials efficiently is paramount. In recent years, the need for a unified clinical trial management platform has become increasingly evident.

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Accelerating Consumer Product Research with Unified Clinical Trial Management Solutions

Cloudbyz

This is where unified clinical trial management solutions come into the picture, enhancing efficiency, reducing time to market, and ensuring high-quality, scientifically validated consumer products. A delay in trials or approval can significantly impact the product’s success and the company’s bottom line.

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Beginner’s Guide to 21 CFR Part 11 Compliance

Advarra

As electronic documentation usage increases in clinical trials, organizations must make sure they’re still protecting participants’ health and safety without sacrificing quality or efficacy. One way to do so is to ensure the software platforms you are using to conduct research are in line with federal regulations.

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Why a Platform Approach is Vital for Clinical Research Management Transformation

Cloudbyz

As it becomes more complex with growing volumes of data, evolving regulations, and the pressure for faster drug development, traditional methods of clinical research management are no longer sufficient. Let’s delve into why this method is paramount for the transformation of clinical research management.

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Q&A: The IND Journey Phase I – Navigating Success

Advarra

The sponsor is the pharmaceutical company conducting the trial. If you mean using a different contract research organization (CRO) for the different phases of clinical trials – that’s different. For good clinical practice (GCP), refer to ICH E6 (R2) Section 5 and address all quality elements.

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Pfizer to Provide U.S. Government with an Additional 3.7 Million Treatment Courses of PAXLOVIDâ„¢ to Help Combat COVID-19

Pfizer

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor. There are limited clinical data available for PAXLOVID.

Drugs 110
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U.S. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™

Pfizer

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor. There are limited clinical data available for PAXLOVID.

Drugs 69