Program Overview

This two- to three-year, 36 credit, evening and 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. In addition, a Certificate in Clinical Research (15 credits) is offered. The Clinical Research Organization and Management Graduate 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
    • Pharmacology of adverse events
    • Writing for clinical research and interpreting medical literature
    • Case studies in the health care industry

• Business and Strategic Planning of New Product Development
  • Intellectual property and technology transfer
  • Business of outsourcing technology and development
  • Financial planning and analysis of clinical trials
  • Negotiating skills
  • Leadership seminar

Who should Apply?

The M.S. in Clinical Research was designed for individuals already trained in the area of clinical sciences, as well as for others who desire focused training in the proper conduct of clinical research. The courses and the content are ideal for:

 Residents and fellows in all therapeutic specialties

• Nurses acting in the role of research coordinator
• Doctors of Pharmacy and Pharmacists
• Nurse Practitioners
• Physician Assistants
• Industry representatives (i.e., CRAs, Project Managers, medical monitors, etc)

 Application Procedures

The application process requires that applicants submit:

Click here to download the application form

• Miller Analogies Test Score (For more information click here)
• Self-Assessment Essays:
  • Discuss personal goals, conditions, or career aspirations that motivate you to pursue graduate study at Drexel University.
    
  • What are your most important accomplishments?
    
  • What do you expect to achieve through this program?
    
• Two recommendations
• College transcripts
• Current resume
• An interview will be required as part of the admission process

Application Deadlines:

• Spring 2008 Application: November 5, 2007
• Summer 2008 Application: April 14, 2008
• Fall 2008 Application: June 13, 2008
• Spring 2009 Application: November 5, 2008 

 Contact Us

To ask about policies, admission criteria, course scheduling and content, please contact:

Linda DiMario, R.Ph., R.N., MSN, MPH
Assistant Professor Family Medicine
Executive Director, CROM
Drexel University College of Medicine
Post-Baccalaureate Pre-Professional Education
245 North 15th Street, Mail Stop344
Philadelphia, PA 19102-1192
Phone: 215-762-4692
Linda.DiMario@drexelmed.edu

or

William Hirschhorn, M.S.
Director of CROM Education
Drexel University College of Medicine
Office of Professional Studies in the Health Sciences
245 N. 15th Street, Mail Stop 344
Philadelphia, PA 19102-1192
Phone: 610-292-9525
William.Hirschhorn@drexelmed.edu

To ask about procedural and application issues please contact:

Melanie J. Fields, B.S.
Program Coordinator
Drexel University College of Medicine
Office of Professional Studies in the Health Sciences
245 N. 15th Street, Mail Stop 344
Philadelphia, PA 19102-1192
Phone: 215-762-4692
Fax: 215-762-8803
Melanie.Fields@drexelmed.edu

For specifc program information please visit: www.drexel.com.