Program Overview
This 36 credit e-learning program was designed after extensive consultation with professionals, representing industry, government, and academia, who are involved in clinical research and new therapeutic product development. The Clinical Research Organization and Management program (CROM) was created and implemented to meet the educational and professional needs of individuals employed or conducting investigations in this increasingly complex and highly regulated field of therapeutic product investigation.
The CROM program is taught in an online format providing maximum student flexibility. No residency requirement or on-site classes are mandated. Courses are conducted in such a manner as to maximize the opportunities for learning, both from student to student as well as from a highly experienced faculty, comprised of outstanding teachers, among them - researchers, administrators, lawyers, and scientists from academia and industry.
The program combines five modules of study devoted to clinical research and related administrative and regulatory issues:
Innovative Product Research and Development
- Courses were designed to hone skills in the essentials for developing new therapeutic products encompassing the basic and clinical sciences and for understanding the trends in clinical research. Emphasis will be placed on research and development in the following areas
- Pharmaceuticals
- Biologics
- Medical devices
- Additional courses will focus on
- Current trends in clinical research
- Clinical trials in diverse populations
- Good clinical research practices
- Health outcomes and economics
- Biotechnology development and regulations
- Regulatory Compliance and Law
- Compliance to ethical, legal, and regulatory standards is essential for ensuring quality research. Using these professional requirements, courses were designed to build a solid core of knowledge in the areas necessary to guarantee the integrity of research involving a human population. Courses such as
- Ethical issues for clinical research
- Foundations of compliance
- Regulatory affairs in R&D
- Issues in compliance and monitoring
- Pharmaceutical law - Part I and Part II
- Quality assurance audits
- Biostatistics and Data Management
- A clinical trial that is improperly designed puts the human research participant at great risk. The following courses will focus on design and data management
- Biostatistical methods
- Epidemiology
- Clinical trial design – basic and advanced
- Data management
- Clinical Research Management and Safety Surveillance
- This module encompasses a variety of courses necessary to better understand project management, the vagaries of the innovative product development industry, and strategies for coping and surviving in this ever shifting environment. Courses include
- Research bioinformatics
- Clinical research administration
- Pharmacovigilance
Drexel University College of Medicine
Office of Professional Studies in the Health Sciences
245 North 15th Street, Mail Stop 344, Room 4104 NCB
Philadelphia, PA 19102
(215) 762-4692
Email: medicalsciences@drexelmed.edu
www.drexel.com