Regulatory Affairs Professionals Society

FDA investigator, experts seek to dispel misperceptions around 483s

Adhering to quality by design (QbD) principles and employing risk-based monitoring strategies should reduce the likelihood of ...
BioProcess International

Integrating Quality by Design Principles into Gene-Therapy CMC Programs: Establishing Manufacturing Control and Comparability

Quality by design is critical for cell and gene therapy manufacturing where process controls directly influence product ...
Drexel University

Quantitative Principles for Clinical Research

This certificate program addresses the needs of residents and fellows to attain knowledge in the basic principles of clinical research — analyzing data, understanding medical literature, and ...
Nature

Improving clinical trial design using interpretable machine learning based prediction of early trial termination

This study proposes using a machine learning pipeline to optimise clinical trial design. The goal is to predict early termination probability of clinical trials using machine learning modelling, and ...
Nature

Principles to guide clinical AI readiness and move from benchmarks to real-world evaluation

We propose straightforward principles to foster an evaluation-forward operating system that can transform the adoption of clinical artificial intelligence from a leap of faith into a stepwise, ...
News Medical

Insight into the Different Clinical Trial Study Designs

Clinical trials are well-controlled and designed experiments that aim to prove that an Investigational Medicinal Product (IMP) is effective. Clinical trial data is submitted to the national health ...
Boston College

Clinical Research Certificate

Whether you aspire to become a Clinical Research Associate, Clinical Trial Coordinator, Regulatory Affairs Specialist, or Clinical Data Manager, our Clinical Research Certificate program will empower ...
ascopubs.org

Global Equity in Clinical Trials: An ASCO Policy Statement

Unification of Efforts to Improve Global Access to Cancer Therapeutics: Report From the 2022/2023 Access to Essential Cancer Medicines Stakeholder Summit ASCO is a global professional society ...