DrugBank

OCTOBER 30, 2024

This lets you focus on what matters most: driving meaningful results in drug research and development. Your Need for Accessible, High-Quality Data—Solved Pharmaceutical research and healthcare innovation demand timely access to comprehensive, up-to-date data.

Production 75

Production Clinical Trials Packaging Compliance 75

Vial

MAY 20, 2024

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. What is a Pre-Clinical CRO? The global preclinical CRO market was estimated to be valued at US$5.7

Clinical Research 52

Clinical Research Clinical Trials Research Trials 52

Conversations in Drug Development Trends

FEBRUARY 21, 2024

Unflinching attention to detail is required to manage AME study participants In AME studies, our top priority is balancing participant comfort and compliance with high-quality data collection. The post Why Proactive AME Studies are Critical to Accelerating Your Approval Journey appeared first on Worldwide Clinical Trials.

Clinical Trials 80

Clinical Trials Pharmacy Clinical Pharmacology FDA 80

Codon

JANUARY 21, 2024

Human challenge trials were an indispensable part of the development of the malaria vaccine, R21/Matrix-M, endorsed by the World Health Organization last October. But for all of their benefits, human challenge trials have their drawbacks. Jake himself has participated in both Zika and Shigella challenge trials.

Vaccine 108

Vaccine Trials Disease Treatment 108

Agency IQ

JUNE 7, 2024

While pre-pandemic, certain manufacturing facilities were required to comply with RRA records requests, the FDA only gained this authority to require compliance from BIMO facilities under the provisions of the Food and Drug Omnibus Reform Act (FDORA) in 2022. “To In general, the agency directs sponsors to section 5.2

FDA 40

FDA Compliance Regulations Production 40

Agency IQ

AUGUST 2, 2024

While the work on the pharma package will likely take quite some time, another deadline is coming up fast: the full transition of all clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation.

Regulations 40

Regulations Clinical Trials Production Trials 40