Clinical Guest Contributors
-
How Is RIM Software Transforming Regulatory Compliance?
6/20/2025
Regulatory information management (RIM) software tools streamline global regulatory processes on a single cloud-based platform throughout the entire product life cycle.
-
Why CRA Proficiency Needs A Boost From Better Assessment And Training
6/20/2025
CRAs intend to fulfill clinical research’s commitment to patient safety. Yet, some fall short of true proficiency, and Gerald DeWolfe contends better evaluations and training can help.
-
EMA Guideline On Clinical-Stage ATMPs Comes Into Effect: On The Verge Of Convergence?
6/19/2025
The EMA’s Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials came into effect on July 1, 2025
-
Single Peptides & Pig Testing: How Longhorn's Developing Its Universal Flu Shot
6/19/2025
CEO Jeff Fischer discusses Longhorn's long-acting universal flu vaccine, from its suitability for testing in pigs to overcoming vaccine hesitancy.
-
BioMarin Generates Patient Experience Data With Early And Often Engagement
6/18/2025
BioMarin Pharmaceutical's Ebony Dashiell-Aje, Ph.D., discusses how early and often patient engagement facilitates rich patient experience data generation.
-
5 Ways To Make Your Investigator Meetings Fun And Functional
6/17/2025
Discover five ways CROs and sponsors can better engage and communicate with site staff for better relationships and better trials.
-
2 Ways To Overcome The Challenge Of Developing Neurological Rare Diseases Drugs
6/16/2025
GRIN Therapeutics CEO Bruce Leuchter, MD, explores how integrating new business models and technological advances will be crucial to developing new treatments for rare neurological disorders.
-
Hidden Compliance Risks In Start-Up That Could Derail Your Clinical Trial
6/13/2025
Kulkarni Law Firm Senior Attorney Edye T. Edens explores the risks embedded in clinical trial start-up activities, such as site activation, contract execution, delegation of responsibilities, and cross-border data flows.
-
A Look At Elsa, The FDA's New AI Digital Assistant
6/12/2025
The U.S. FDA recently launched its very own generative AI tool called Elsa. It's designed to assist FDA employees across various functions, from scientific reviewers to investigators.
-
J&J Survey Of Oncologists Reveals Challenges With Awareness & Access
6/12/2025
J&J President, U.S. Solid Tumor Biljana Naumovic discusses the company's Oncology Care Index, which revealed issues with oncology provider awareness of and access to clinical trials.