The Association of Clinical Research Organizations (ACRO) represents the world's leading clinical research organizations. ACRO's members provide specialized services that are integral to the development of drugs, biologics, and medical devices. ACRO advances clinical outsourcing to improve the quality, efficiency, and safety of biomedical research.

ACRO reaches out to:

Clinical research organizations of any size, who can rely on ACRO to represent the clinical trials industry to sponsors, health policy makers and the public, and to advance the common interests of research and development services companies.

Pharmaceutical, biotechnology and medical device companies, who call upon CRO resources and expertise to help bring new treatments to patients quickly and safely.

Legislators and regulators, who need unbiased information about clinical trials in order to make decisions in the best interest of patient care and safety.

Patients and patient advocacy groups, who dedicate themselves to furthering research and improving treatments for specific diseases or populations.

Media, who may gather facts about medical research and require authoritative information from clinical trial experts.

ACRO membership at-a-glance

2008 Chair: David Spaight, President, MDS Pharma Services
2007 Chair: Jeffery McMullen, President and CEO, PharmaNet Development Group
2006 Chair: Candace Kendle, Chairman and CEO, Kendle
2005 Chair: Josef von Rickenbach, Chairman and CEO, PAREXEL International
2004 Chair: Chris Kuebler, Chairman and CEO, Covance
2003 Chair: Fred Eshelman, CEO, PPD
2002 Chair: Dennis Gillings, Chairman and CEO, Quintiles Transnational

• ACRO member companies employ more than 40,000 people worldwide, conduct research in over 60 countries, and generate an estimated two-thirds of a more than $10 billion worldwide industry.
  
  
• CROs provide a wide range of research services to pharmaceutical, biotechnology, and medical device company sponsors, including consultation with study design, investigator recruitment, study monitoring, and data analysis.
  
  
• Each year, approximately 80,000 clinical trials focused on the development of new drugs, new medical devices, and new treatments are conducted by more than 30,000 investigators . The work involves approximately 20 million persons.
  
  
• The drug discovery and development process is extremely time-consuming and expensive. The Tufts Center for the Study of Drug Development estimates that the cost to develop a new prescription drug increased from $231 million in 1987 to $897 million in 2003, and it typically takes between 10 and 15 years to develop a new prescription drug and obtain approval to market it in the United States.
  
  
• The clinical stage is the most time-consuming and expensive part of the drug development process, making up over 38% of the total research and development expenditure. On the whole, roughly 25% of all clinical trials are outsourced. Of phase I-III trials not conducted in-house by the sponsor, CROs are involved in about 64%, while approximately 36% are conducted in academic medical centers.
  
  
• It is estimated to cost between $1 million to $ 1.3 million each day a drug's approval is delayed, based on lost revenue potential for a top-selling drug. Because it is not always financially practical to maintain redundant development staffs, drug companies commonly rely on outsourcing to CROs to shorten product development time and cut fixed overhead costs, leading to timelier drug introduction and greater sales revenues over time.

• The Common Rule, which applies to research conducted or funded by Federal agencies, such as National Institutes of Health (NIH).
  
  
• U.S. Food and Drug Administration (FDA) regulations, which apply to commercially sponsored clinical research related to the development, review, and approval of new drugs, biological products, and medical devices.
  
  
• Broadly, the Common Rule uses a system of assurances , while FDA regulations employ a compliance model that requires detailed documentation.