The clinical research enterprise has a remarkable record of determining the safety and efficacy of new medicines. It's a global undertaking, requiring the methodical and painstaking compilation of information on the experience of hundreds of thousands of study participants with new treatments.

Clinical trials follow a careful scientific methodology that emphasizes the well-being of its participants and the accuracy of the data gathered. Around the world, hundreds of thousands of researchers are engaged in this work, bridging the space between laboratory and doctor's office. They help a treatment's potential translate into fact by determining if it's safe to use and effectively addresses the conditions it is designed to treat.

Over the years, the performance of researchers, research monitors and others has become integral to the drug development process. Clinical Research Organizations (CROs) have become experts on the design, execution and management of clinical trials, and drug sponsors rely on them to shoulder an increasing proportion of the work involved in testing a new medication's performance. According to the Tufts Center for the Study of Drug Development (CSDD) - which in 2006 published the first independent, third-party examination of the CRO industry’s rapid growth – outsourcing to CROs has increased the speed and efficiency of the pharmaceutical product pipeline while maintaining high levels of data quality and regulatory compliance.

Through the Association of Clinical Research Organizations (ACRO), CROs are deeply involved in efforts to examine the clinical trial process and find ways to improve it. For example, ACRO is one of the first organizations to begin working with the Clinical Trials Transformation Initiative (CTTI), a public-private partnership hosted by the Duke University Medical Center under the auspices of the U.S. Food and Drug Administration. Made up of representatives from government, industry, patient advocacy groups, professional societies and academia, CTTI's mission is to develop new standards and identify new methods and technologies that will enhance safety measures, boost data quality even further, and make the research process more efficient.    

ACRO is also active in efforts to develop biomarkers as research tools. We see the impressive potential the use of biomarkers can have on making effective treatments available to patients who not so long ago might have been without hope. Our member companies serve on three steering committees of The Biomarkers Consortium, a public-private research partnership run by the Foundation for the National Institutes of Health (NIH) supporting the discovery and development of biomarkers for use in drug development, preventive medicine and diagnosis. With our partners in the drug sponsor companies, regulatory agencies and  other areas of research and medicine, we share the common goal of seeing this work done safely, effectively and with a high level of quality.

Because of the growing role CROs play in medical research, it makes sense for us to share our expertise by participating in efforts to develop new types of medical treatments or new approaches to research. Our expertise is fundamentally important, and by taking leadership roles in such endeavors, we can ensure issues involving patient safety and data accuracy are thoroughly addressed. We're welcomed in these discussions because safety and accuracy top the list of priorities for everyone involved in clinical research, whether they're a researcher, a drug sponsor or a government official.

Today's clinical research enterprise has an impressive record of transitioning new treatments into the market safely and efficiently, and both regulators and drug sponsors recognize CROs for the excellence of their contribution. Because such excellence is at least partly based on a desire to constantly improve, we view participation in organizations such as the CTTI and The Biomarkers Consortium to be an important component of our work.