Resources

Industry Links

Clinical Research Primer
Background Information on Clinical Research in the USA.

FDA Intro
How FDA Evaluates Regulated Products

FDA Guidance
Guidance: Find out the Agency's current thinking on various topics.

Japan (MHLW)
Japan's Ministry of Health, Labor and Welfare

Europe (EMA, Formerly EMEA)
European Medicines Agency

CDISC
Clinical Data Interchange Standards Consortium (ODM, STDM, ADaM)

MedDRA MSSO
The Medical Dictionary for Regulatory Activities is the standard for coding medical terminology.

WHO Drug Dictionary (UMC)
The World Health Organization Drug Dictionary from Uppsala Monitoring Center - the standard for coding medicinal products (drugs).

LOINC
Lab Standardization: Logical Observation Identifiers Names and Codes

DIA
The Drug Information Association

Applied Clinical Trials
Journal with archives, links to international agencies, current pharma stock quotes.

Society for Clinical Research Associates
An organization dedicated to the continuing education and development of clinical research professionals.

Society for Clinical Data Management
An organization dedicated to advancing the discipline of clinical data management.

Contract Pharma
Find information on outsourcing your research and clinical trials.