Clinical Research News

Welcome to Clinical Research News. Read our articles to stay ahead of current industry trends and key regulatory developments.
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Bronchoscopy for Local PK Studies in Healthy Volunteers

For drug products that are not intended to be absorbed into the bloodstream, bioavailability may be assessed by measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of action.

Manufacturing Virus for Human Challenge Studies

The Viral or Human Challenge Model (HCM) is increasingly being considered by those wishing to accelerate the development of novel agents in the treatment of infectious diseases.

Optimizing the Sponsor-CRO Relationship Through a Hybrid Outsourcing Strategy

Within the pharmaceutical industry, there are six dominant methods used to model outsourcing strategy between a sponsor company and a clinical research organization (CRO): Ad Hoc, Preferred Provider, Functional Outsourcing, In-sourcing, Sole-Provider, and Compound-based Outsourcing

European Regulatory Authorities Explained

We introduce and explain the EU regulatory landscape.

How to Improve Patient Recruitment in Viral Challenge Testing

One of the most important challenges in realizing high quality clinical trials is patient recruitment.

Regulatory Requirements for Viral-Challenge Studies: Influenza Case Study

In virus challenge studies, healthy volunteers are administered a pathogenic or virulent strain of virus. We discuss the regulatory requirements for this practice.

Implementation of CDISC ADaM in the Pharmacokinetics Department

The FDA encourages the use of Clinical Data Interchange Standards Consortium (CDISC) standards for submission of clinical trial data.