article thumbnail

Opinion: Subject, not suspect: The new hazards of conducting clinical research in the Dobbs era

STAT News

Here’s a scenario anyone who has done clinical research will recognize: A 32-year-old woman participating in a Phase 1 healthy-volunteer crossover clinical trial tested negative for pregnancy when she enrolled and agreed to use contraception during the course of the trial, as specified in the protocol.

article thumbnail

WCG Publishes Report Providing Assessment of Motivators Across All Clinical Research Stakeholders

WCG Clinical

Princeton, NJ, July 12, 2023 – WCG, one of the world’s leading providers of solutions that measurably improve the quality and efficiency of clinical research, released its 2023 Avoca State of the Industry Report. Avoca joined the WCG family of companies in April 2021. For more information, visit www.theavocagroup.com.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

CDISC standards in clinical research

pharmaphorum

In this blog, we provide an overview of the CDISC standards used in clinical research. For example, an Adverse Events dataset and the variables it contains. Content standards fall under these four stages of the research process: Protocol Representation Model (PRM). Two groups of CDISC standards. Data exchange standards.

article thumbnail

Risk Assessment for use of Engineered Genetic Materials in Clinical Research

Advarra

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. IPs containing engineered genetic materials may pose risks potentially not anticipated by the clinic’s standard infection control policies.

article thumbnail

Leading clinical packaging companies in contract marketing

Pharmaceutical Technology

Unlike commercial pharmaceutical packaging, the primary consideration in clinical trial packaging is protecting the product quality and reliability for research. Finding the best clinical trial packaging services providers.

Packaging 100
article thumbnail

EMA sets out proposals to reform EU’s clinical trials framework

pharmaphorum

The European Commission, EMA and national regulators within the EU have launched an initiative to change the way clinical trials are designed and run in order to position the bloc as an international “focal point” for clinical research.

article thumbnail

A review of Japan’s drug discovery and development landscape  

Drug Discovery World

DDW Multimedia Editor Megan Thomas takes a broad look at the drug discovery and development landscape in Japan and highlights how it is bolstered by government policies, investment, collaboration, start-up ecosystems and academic research. . Developing and securing human resources with digital skills.