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Association of the British Pharmaceutical Industry
This site provides information and statistics on the pharmaceutical industry,
ABPI publications, as well as education, training, and career resources.

Association of Clinical Research Organizations
The ACRO site highlights the key issues for CROs and also provides market trends. In addition, it also acts as a resource for pharma and biotech sponsors, patients, and patient advocates.

Association of Clinical Research Professionals
Beyond its extensive training and education resources, ACRP is a one-stop
source for public policy updates. Also available to its members is an online
community, including eForums, a member directory, and a resource library.

Biotechnology Innovation Organization
BIO's site provides information regarding national, state, and local issues of
industry. Users can also find BIO news, blogs, and podcasts through this site.

CDISC, Clinical Data Interchange Standards Consortium
Provides free downloadable CDISC standards, news on the latest initiatives, an active discussion board, links to regulatory documents and published articles, and a CDISC Glossary of clinical research terms, acronyms, and abbreviations.

CISCRP, Center for Information & Study on Clinical Research Participation
Visitors can find a wealth of information and resources—facts, figures, Web
sites—and have the chance to connect with patients, caregivers, and families by joining the Clinical Research Volunteers Community.

Clinical Trials Transformation Initiative
Laying out the background, scope, and principles of this initiative, the site also provides an area for any interested party to submit a project idea, information on becoming a member, as well as a breakdown of the members behind CTTI.

Drug Information Association
Find out about upcoming DIA events, webinars, training, internships, and
certification programs. DIA's online community is for members only, but
non-members are still able to access the job bank and view resumes.

EFGCP: Impact on Clinical Research of European Legislation
A report that aims to measure and analyse the direct and indirect impact of the Clinical Trials Directive 2001/20/EC and related legislations in the EU.

EPEMED: European Personalized Medicine Association
A not-for-profit organization bringing together global forces in personalized medicine.

EUCROF: The European CRO Federation
An orgaization that aims to promote clinical research of high quality in Europe in general and in the European Union in particular.

HL7, Health Level Seven
Six main categories make up this standards developing organization's site:
About HL7, Events, Members Only, Membership, Resources, and Work
Groups. Most resources are accesible to nonmembers, including the bookstore.

Pharmaceutical Research and Manufacturers of America
Visitors can find PDFs on topics like cancer and women's health, instructional videos, helpful links, a database that lists drugs currently in clinical trials or at FDA for review, and reports on medicines in development.

Regulatory Affairs Professionals Society
Visitiors can make use of professional advancement opportunities, pick up
a Title 21 CFR Pocket Guide at the bookstore, scan for a new job or
employee, check out upcoming meetings, or peruse the available coureses.

Society for Clinical Data Management
An educational portal leads to SCDM's upcoming webinars as well as
numerous resources for the clinical data manager certification exam,
which SCDM offers. The site also features a job postings section.

Society of Clinical Research Associates
Find upcoming meetings, conferences, and in-person courses. Make use of
instructions for submitting articles for the SoCRA Source journal, a classified section for clinical research jobs, and information on certification programs.

Society of Quality Assurance
The purpose of this site is to serve the needs of members,
and to inform prospective members and the general public about SQA, what opportunities it offers and what its members do.



FDA Home Page
Providing information for consumers, industry, and health professionals,
this site covers current science and research, regulations and laws, backgroundinformation about the FDA, new drug approvals, and drug safety information.

FDA Electronic Submissions Gateway
Enabling the submission of regulatory information for review, this is the
FDA's Agency-wide solution for accepting electronic regulatory submissions.

FDA–European Union
This site covers the international activities taking place between the FDA
and European Union's European Agency for the Evaluation of Medicinal
Products and European Commisson.

Current Guidances
This site provides all guidance documents set out by the FDA, organized
by the Agency's different centers and also including those from the
Office of the Commissioner.

The Center for Biologics Evaluation and Research (CBER)
Find information regarding the different types of products CBER regulates,
read documents frequently requested by the Freedom of Information Act,
and learn about training programs, meetings, and research in this area.

The Manual of Regulatory Standard Operating Procedures and Policies
This manual covers the procedures and policies that are in place for
operations that take place within the FDA.

The Center for Drug Evaluation and Research (CDER)
The official site for the drug branch of the FDA, which includes news,
general safety and side effects information, new drug approvals,
and alerts and warnings for approved drugs. Visitors can also find details
guidances developed by the agency and enforcement information.

Sign up for Email Updates from the FDA
All available CDER mailing lists.

The Data Standards Manual
This manual compiles all of the standardized nomenclature monographs
that have been reviewed and approved by the FDA Data Standards Council.

Guidance documents specific to CDER
A record of guidance documents arranged by subject, as well as links to
additional information about guidances, including updated lists of ones that
are new, revised, or withdrawn.

The CDER Manual of Policies & Procedures
Users can find information on all of the review and approval processes
CDER is responsible for, contact details for people within the Center, as
well as a search option for FDA acronyms and abbreviations.

CDER's regulatory guidance section
A comprehensive list of CDER's guidances and enforcement information.

The Office of Regulatory Affairs (ORA)
A resourceful site that includes compliance, inspectional, and science references, a list of popularly requested documents, recent ORA publications, and hot topics, such as training courses, GLP and AIP lists, and ORA events.

FDA and ORA site
Find links to all content related to Compliance References used by FDA personnel.

The Compliance Policy Guide
Revisions and updates to ORA's Compliance Policy Guides Manual,
dating from 1998 to present.

Guide to Inspections
This site provides reference materials for investigators and FDA personnel
for inspections.



Centers for Medicare & Medicaid Services
This site provides a listing of different CMS programs and detailed
information for each, an up-to-date newsroom, the top 10 links on the
site, as well as numerous links related to research, statistics, and data.

Children and Clinical Studies
The National Heart Lung and Blood Institute here offers an entire site
dedicated to the practice of clinical research in children.

European Medicines Agency
The official EMA site includes basic Agency information, including its
committees, events, meetings, job opportunities, and press releases. Beyond
this, there's information on products, EU legislation, and emerging science.

National Institutes of Health
Along with a detailed overview of the Agency, the site provides an A-Z
index of health topics, grant information, current industry news, research
results, and a listing of the institutes, centers, and offices that make up the NIH.

Agency for Healthcare Research and Quality (AHRQ)
AHRQ supplies a variety of clinical information ranging from scientific
reviews, treatment and research findings, comparative clinical effectiveness and technology reviews to current and archived clinical practice guidelines.



Applied Clinical Trials Blog
The Applied Clinical Trials blog offers area of discussion on news and analysis of the business and trends in the clinical trials industry.

BioClinica Trial Blazers Blog
BioClinica's Trial Blazers blog covers the latest news on clinical trials direct from industry experts.

Drug and Device Law
This blog is devoted to discussing topics related to pharmaceutical and
medical device product liability litigation.

This blog covers the regulatory aspects of medical products. Users can
also find FDA links, industry news updates, and links to relevant videos
on YouTube.

Pharmaceutical Executive 
Discourse, dialogue, and discussion about global pharma matters.
PRIM&R's Amp&rsand Blog
Public Responsibility in Medicine and Research (PRIM&R) provides news through its blog, discussions on ethic-related topics.

Wall Street Journal's Health Page
Covering health and the business of health, WSJ's health blog presents analysis of the latest news in industry.



Canada Trials
Both patients and researchers can find here clinical trials information in Canada. Along with finding medical news, patients can find support groups, researchers can post a trial, and sponsors can search center profiles.
CDISC Acronyms, Abbreviations, and Initials
Will be updated December 2016
These translations help make sense of initials commonly used by clinical researchers around the world.
CDISC Clinical Research Glossary
Will be updated December 2016
A glossary that includes even more terms relevant to clinical trials professionals.
CenterWatch Clinical Trials Listing Service
Beyond being a global news source for clinical research professionals and patients, CenterWatch offers directories, analysis, and market research.
As a service of the U.S. National Institutes of Health this is a registry of federally and privately supported clinical trials conducted globally.

The Federal Register
A Web-based filing of the rules, proposed rules, and notices of Federal agencies and organizations, as well as executive orders and other presidential documents, which are provided from the year 2000 and on.

Practical Considerations for Clinical Trial Sites Using Electronic Health Records Certified for Clinical Research
This paper from the EHRCR Project addresses regulatory considerations regarding clinical trial sites using electronic health records.

WHO International Clinical Trials Registry Platform (ICTRP)
This site facilitates access to worldwide information about controlled trials
and their results, trial registration, datasets, and news.

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