Health Decisions CEO Authors First Complete Guide to Adaptive Clinical Research
Wiley Publishers Releases “The Agile Approach to Adaptive Research: Optimizing Efficiency in Clinical Development,” by Michael Rosenberg, MD, MPH.
Durham, NC, January 25, 2010 --(PR.com)-- The drug development industry’s first full-spectrum guide to adaptive clinical research will be released Friday, January 22 from John Wiley & Sons Publishers. Presenting a comprehensive exploration of fresh and demonstrated solutions to the sinking productivity levels of the last decade, “The Agile Approach to Adaptive Research: Optimizing Efficiency in Clinical Development” is intended to arm researchers with tools and knowledge to navigate the rapidly diversifying landscape of the future.
According to author Michael Rosenberg, MD, MPH, the key to improving the success rate of new drugs and devices is agile clinical development, which he defines as the expansion of the adaptive research concept to all trial functions. This means identifying and implementing the right mix of adaptations—both design and operational—to meet the objectives of each unique study.
"By enabling better, earlier decisions, agile clinical development provides a far faster and less costly path to market, by as much as forty percent compared to traditional approaches," said Dr. Rosenberg. "These gains in efficiency reduce investment risk and make it possible to treat currently underserved populations, representing a wealth of opportunity for those willing to embrace adaptive methodologies."
“The Agile Approach to Adaptive Research” includes real-world case histories and examples from Dr. Rosenberg’s two decades as founder and president of Health Decisions (www.HealthDec.com), a full-service CRO specializing in high-efficiency adaptive solutions. Under Dr. Rosenberg’s guidance, Health Decisions has achieved benchmark successes for its sponsors with its Agile Clinical Development platform¾a flexible yet secure network of processes and technology that integrates adaptive design with adaptive operations.
In support of Dr. Rosenberg’s book, Health Decisions will hold a weekly drawing for free copies. To enter, visit www.HealthDec.com/page/book-giveaway.
“The Agile Approach to Adaptive Research” is also available from Wiley & Sons Publishers (www.wiley.com/WileyCDA/WileyTitle/productCd-0470247517.html) and Amazon (www.amazon.com/agile-approach-adaptive-research-pharmaceutical/dp/0470247517).
For more information, please contact Katie Hendrick by email at khendrick@HealthDec.com or by phone at +1.919.967.1111 x116.
About the Author
Dr. Michael Rosenberg has been active in clinical research for more than 30 years, designing or conducting more than 300 studies worldwide in a range of therapeutic areas. Early in his career, he realized that excellence in clinical research requires elevating managerial standards to the same high level as scientific standards. He founded Health Decisions in 1989 to develop a more efficient approach to managing clinical trials.
Before founding Health Decisions, Dr. Rosenberg served as Executive Director and Chief Executive Officer of the American Social Health Organization, Director of the Reproductive Epidemiology Division of Family Health International, and Chief, Reproductive Health Activity, at Centers for Disease Control. He currently serves on the Leadership Council of the Harvard School of Public Health and as co-principal investigator of the Clinical and Statistical Coordinating Center for Contraceptive Research, National Institutes of Health. He has published more than 200 scientific articles, serves on the editorial boards of Current Drug Discovery and Contraceptive Technology Update, and is a reviewer for several journals.
Dr. Rosenberg also serves as Clinical Professor of Obstetrics and Gynecology at the University of North Carolina School of Medicine and Adjunct Professor of Epidemiology at the UNC School of Public Health. He is a Fellow of the American College of Physicians (Internal Medicine), the American College of Epidemiology, and the American College of Preventive Medicine. He completed his undergraduate and medical degrees at the University of California and received a Master's Degree in Epidemiology and Biostatistics from the Harvard School of Public Health.
About Health Decisions
Health Decisions (www.HealthDec.com) is a global clinical research organization (CRO) committed to helping drug and device companies achieve greater success. Our sponsors rely on us to help them prove the value of their pipelines both faster and with the smartest possible allocation of funds. Through Agile Clinical Development—a strategic combination of adaptive design and adaptive operations—Health Decisions optimizes every facet of clinical research from design protocol to the most detailed day-to-day management, so sponsors can make the most of competitive market opportunities.
Health Decisions is headquartered in Durham, NC, with over twenty years of experience helping sponsors achieve success in Phase I-IV trials across all major therapy areas. For more information, please visit the company's website at www.HealthDec.com.
About John Wiley & Sons
Founded in 1807, John Wiley & Sons, Inc. has been a valued source of information and understanding for more than 200 years; helping people around the world meet their needs and fulfill their aspirations. Wiley and its acquired companies have published the works of more than 350 Nobel laureates in all categories: Literature, Economics, Physiology/Medicine, Physics, Chemistry, and Peace.
Wiley’s core businesses include scientific, technical, medical, and scholarly journals, encyclopedias, books, and online products and services; professional/trade books, subscription products, training materials and online applications and Web sites; and educational materials for undergraduate and graduate students and lifelong learners. Wiley’s global headquarters are located in Hoboken, New Jersey, with operations in the US, Europe, Asia, Canada, and Australia. The Company’s Web site can be accessed at www.wiley.com. The Company is listed on the New York Stock Exchange under the symbols JWa and JWb.
###
According to author Michael Rosenberg, MD, MPH, the key to improving the success rate of new drugs and devices is agile clinical development, which he defines as the expansion of the adaptive research concept to all trial functions. This means identifying and implementing the right mix of adaptations—both design and operational—to meet the objectives of each unique study.
"By enabling better, earlier decisions, agile clinical development provides a far faster and less costly path to market, by as much as forty percent compared to traditional approaches," said Dr. Rosenberg. "These gains in efficiency reduce investment risk and make it possible to treat currently underserved populations, representing a wealth of opportunity for those willing to embrace adaptive methodologies."
“The Agile Approach to Adaptive Research” includes real-world case histories and examples from Dr. Rosenberg’s two decades as founder and president of Health Decisions (www.HealthDec.com), a full-service CRO specializing in high-efficiency adaptive solutions. Under Dr. Rosenberg’s guidance, Health Decisions has achieved benchmark successes for its sponsors with its Agile Clinical Development platform¾a flexible yet secure network of processes and technology that integrates adaptive design with adaptive operations.
In support of Dr. Rosenberg’s book, Health Decisions will hold a weekly drawing for free copies. To enter, visit www.HealthDec.com/page/book-giveaway.
“The Agile Approach to Adaptive Research” is also available from Wiley & Sons Publishers (www.wiley.com/WileyCDA/WileyTitle/productCd-0470247517.html) and Amazon (www.amazon.com/agile-approach-adaptive-research-pharmaceutical/dp/0470247517).
For more information, please contact Katie Hendrick by email at khendrick@HealthDec.com or by phone at +1.919.967.1111 x116.
About the Author
Dr. Michael Rosenberg has been active in clinical research for more than 30 years, designing or conducting more than 300 studies worldwide in a range of therapeutic areas. Early in his career, he realized that excellence in clinical research requires elevating managerial standards to the same high level as scientific standards. He founded Health Decisions in 1989 to develop a more efficient approach to managing clinical trials.
Before founding Health Decisions, Dr. Rosenberg served as Executive Director and Chief Executive Officer of the American Social Health Organization, Director of the Reproductive Epidemiology Division of Family Health International, and Chief, Reproductive Health Activity, at Centers for Disease Control. He currently serves on the Leadership Council of the Harvard School of Public Health and as co-principal investigator of the Clinical and Statistical Coordinating Center for Contraceptive Research, National Institutes of Health. He has published more than 200 scientific articles, serves on the editorial boards of Current Drug Discovery and Contraceptive Technology Update, and is a reviewer for several journals.
Dr. Rosenberg also serves as Clinical Professor of Obstetrics and Gynecology at the University of North Carolina School of Medicine and Adjunct Professor of Epidemiology at the UNC School of Public Health. He is a Fellow of the American College of Physicians (Internal Medicine), the American College of Epidemiology, and the American College of Preventive Medicine. He completed his undergraduate and medical degrees at the University of California and received a Master's Degree in Epidemiology and Biostatistics from the Harvard School of Public Health.
About Health Decisions
Health Decisions (www.HealthDec.com) is a global clinical research organization (CRO) committed to helping drug and device companies achieve greater success. Our sponsors rely on us to help them prove the value of their pipelines both faster and with the smartest possible allocation of funds. Through Agile Clinical Development—a strategic combination of adaptive design and adaptive operations—Health Decisions optimizes every facet of clinical research from design protocol to the most detailed day-to-day management, so sponsors can make the most of competitive market opportunities.
Health Decisions is headquartered in Durham, NC, with over twenty years of experience helping sponsors achieve success in Phase I-IV trials across all major therapy areas. For more information, please visit the company's website at www.HealthDec.com.
About John Wiley & Sons
Founded in 1807, John Wiley & Sons, Inc. has been a valued source of information and understanding for more than 200 years; helping people around the world meet their needs and fulfill their aspirations. Wiley and its acquired companies have published the works of more than 350 Nobel laureates in all categories: Literature, Economics, Physiology/Medicine, Physics, Chemistry, and Peace.
Wiley’s core businesses include scientific, technical, medical, and scholarly journals, encyclopedias, books, and online products and services; professional/trade books, subscription products, training materials and online applications and Web sites; and educational materials for undergraduate and graduate students and lifelong learners. Wiley’s global headquarters are located in Hoboken, New Jersey, with operations in the US, Europe, Asia, Canada, and Australia. The Company’s Web site can be accessed at www.wiley.com. The Company is listed on the New York Stock Exchange under the symbols JWa and JWb.
###
Contact
Health Decisions
Katie Hendrick, Marketing Specialist
919-960-1111x116
www.HealthDec.com
Katie Hendrick, Marketing Specialist
919-960-1111x116
www.HealthDec.com
Contact
Categories