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Clinical trial companies see immense relevance on US FDA Electronic Submission Safety Reports

AuroBlog - Aurous Healthcare Clinical Trials blog

Clinical trial companies see immense relevance on US FDA Electronic Submission Safety Reports. The guidance provides instructions about how the individual case safety reports (ICSRs) from investigational new drug (IND) need to be supported with Adverse Event Reporting System (AERS).

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How Pharmacogenomics Can Benefit Your Clinical Trial

Worldwide Clinical Trials

In the increasingly advancing world of medicine, personalized care is a key factor that can progress your drug development efforts. One way to ensure customized disease management is to utilize pharmacogenomics (PGx) in your clinical trial. Reduces Trial Failures Oftentimes, clinical trials may fail due to a lack of efficacy.

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New Weight Loss Drug May Launch in US After Promising Clinical Trial

AuroBlog - Aurous Healthcare Clinical Trials blog

Pharmaceutical giant Eli Lilly said Thursday it will seek approval to add its diabetes drug to the buzzy US weight loss market after achieving promising results in a new clinical trial. Tirzepatide, currently approved to treat type 2 diabetes under the name Mounjaro, is taken once a week as an injection.

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Insights from Industry Experts: Examining the Patient Experience in Clinical Trial Design

Worldwide Clinical Trials

With the necessary prioritization of various factors when designing your clinical trial, the patient experience can be overlooked or improperly addressed in study design. However, incorporating the patient experience into your design is one of the best ways to ensure your drug development program is a commercial success.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management.

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How using AI in clinical trials accelerates drug development

Pharmaceutical Technology

The need for new medical treatments and drugs has never been greater. But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S.

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NPPA looks into fixation of retail price of drugs under phase IV clinical trials

AuroBlog - Aurous Healthcare Clinical Trials blog

The National Pharmaceutical Pricing Authority (NPPA) may fix the retail price of formulations which are under phase IV clinical trials based on the company’s application submitted to the central drug regulator for conducting the phase of clinical trials and other documents along with the relevant form.