Regulatory

FDA Home Page
FDA CBER What's New
FDA Electronic Common Technical Document (eCTD) Information
International Conference on Harmonization (ICH)
European Agency for the Evaluation of Medicinal Products (EMEA)
Medicines Control Agency (MCA)
Canadian Heath Products and Food Branch
21CFR Part 11 Information

Professional  Associations

Drug Information Association (DIA)
Pharmaceutical Research and Manufacturers of America (PhRMA)
BioPharmaceutical Network - PhRMA Working Group on Adaptive Trials
Society for Clinical Trials (SCT)
American Statistical Association (ASA)
ASA Biopharmaceutical Section
Eastern North American Region/International Biometric Society (ENAR)
Western North American Region/International Biometric Society (WNAR)
Regulatory Professionals Society (RAPS)
International Society for Pharmacoepidemiology (ISPE)

Implementation

ClinicalTrials.gov NIH-Sponsored Clinical Trials Registry
CDISC - Clinical Data Interchange Standards Consortium
Association for Clinical Data Management
Society for Clinical Data Management, Inc.
Project Management Institute
Medical Dictionary for Regulatory Activities (MEDRA)
Applied Clinical Trials

Journals

Drug Information Journal
Controlled Clinical Trials
Clinical Trials Journal
Journal of the American Statistical Association
A Journal of the International Biometric Society
Statistics in Medicine  
Statistical Methods in Medical  Research

Ethics

The Declaration of Helsinki
The Nuremberg Code
CIOMS International Ethical Guidelines for Biomedical Research Involving
Human Subjects
IRB Guidebook, OHRP
Ethical Guidelines for Statistical Practice