Good Clinical Practices
EMU’s graduate certificate in good clinical practices is designed to provide an opportunity for individuals to obtain the skills necessary to enter the various professions supporting the drug and medical device development process. Professionals currently participating in the clinical research enterprise can increase their knowledge base as well as their research/creative skills and facilitate a pathway for upward mobility.
During the past ten years, there has been tremendous growth in the expenditures for pharmaceutical research and development, made by both traditional pharmaceutical companies and by the emerging biotechnology industry. This growth has been fueled by many factors, including the emergence of new discoveries and manufacturing technologies, new drug therapies, the Human Genome Project, high throughput screening and the need for new pharmaceuticals and medical devices that has been generated by population growth and the aging of the “baby boom” generation. New drug and medical device technologies have created a steady flow of clinically significant candidates for pharmaceutical and medical product development.
The growth of this industry has been global and has seen the emergence of countries in the developing world (China, India, Eastern Europe and South America) as sites for the conduct of clinical trials. It has been estimated that for every physician clinical investigator, there are six support staff whose skills are essential to the development process that adds new drugs and devices to the marketplace. These include clinical coordinators, project managers, clinical monitors, data coordinators and regulatory affairs professionals.
There is strong demand for these individuals in both the U.S. and Europe, but especially in the developing countries. This shortage is expected to continue as the number, size and complexity of clinical studies on new chemical entities and biotechnology related products increases. Graduates will have the knowledge bases and the hands-on skills to help fill this global need.
Program of Study
- CLRA 510 Introduction to Drug Development (3)
- CLRA 520 Clinical Study Management I (3)
- CLRA 530 Clinical Study Management II (3)
- CLRA 540 Advanced Topics in Clinical Research Administration (3)
- CLRA 550 Preceptorship in Drug Development (3)
- ESLN 592 Professional Healthcare Communication for International Students (3)
*Required for all students who require a TOEFL score to enter the University.
For More Information
Stephen A. Sonstein, Ph.D.
Director, Clinical Practices
Eastern Michigan University
206E Marshall Building
Ypsilanti, Michigan 48197
734.487.1238 | Fax: 734.487.4095
Read more information by downloading the fact sheet [PDF].