Online Certificate in Clinical Trials Design & Research
Founded in 2014, the Clinical Trials Design and Research Graduate Certificate provides individuals a formal opportunity to further their knowledge in clinical trial design.
Clinical Trials Design and Research Graduate Certificate Highlights
High Quality Education
Students take this program to deepen their knowledge of various aspects of drug development, including regulatory, pharmaceutical, biopharmaceutical, medical device, contract research organizations, contract laboratories, manufacturing, as well as academic health centers and research institutions.
Along with our Clinical Trials Design and Research certificate, we offer a Masters in Pharmaceutical Sciences with an emphasis on Pharmaceutics/Drug Development as well as the Global Regulatory Affairs in Drug Development certificate. These three options are all online, asynchronous and available to part-time and full-time students.
All credits taken as part of this certificate may be subsequently applied toward the Masters in Drug Development Sciences.
Flexibility
- 100% online
- Only 12 credit hours
- Start in the fall, spring, or summer semester
Support from Application through Graduation
At UC, you’ll have a full support team behind you:
Enrollment Services Advisor: Your partner through the application process, getting enrolled, and starting your program
Student Success Coordinator: Helping you prepare for classes and stay on track
Access to Resources: Access to university resources that will support you through your program including online learning expectations and resources, health and wellness resources, and academic support
The online Certificate in Clinical Trials Design & Research is 12 credit hours and can be completed in 1 year. The program in aims to program a global view of the contemporary scientific, regulatory, economic, and operational issues pertaining to all phases of clinical trials-starting from early clinical pharmacology to market launch and beyond.
| Course | Title/Description | Credit |
|---|---|---|
| PHDD8050 | Phase I/II Clinical Trials Research and Design This course will provide an understanding on the early clinical drug development activities for newchemical entity that has received IND approval. Concepts of early clinical pharmacology studies, typically conducted in a Phase I setting such as single and multiple dose pharmacokinetics, dose escalation studies to determine the safety and tolerability of drug, mass balance and drug metabolism studies and bioavailability studies will be taught. Emphasis will then be placed on Phase II trials as proof-of-principle, and on the dose-ranging requirements for Phase II. Trial designs including cross-over and parallel group will be discussed. The importance of Phase I/II trials for making dose selections for Phase III will be explored, as will the use of Phase II trials as a go/no-go decision point. The importance of exposure-response (PK/PD) information in guiding the go/no-go decision will also be discussed. The use of biomarkers and pharmacogenomic information in decision making will be addressed. Activities which run in parallel to PhaseI/II trials, including formulation development and clinical supplies and toxicology studies will be discussed. |
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| PHDD8060 | Statistical Principles in Clinical Research The course is designed to teach the statistical principles involved in designing clinical research studies to support new drug development programs. Statistical analysis techniques commonly used will be discussed as well as the newer approaches being considered. Statistical topics addressed in regulatory guidelines will be discussed. Emphasis will be placed on the use of statistical software such as JMP. Hands on exercises using the latest version of JMP will be conducted in various classes. |
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| PHDD8070 | Phase III/IV Clinical Trials and Research This course will provide a comprehensive background in the design and conduct of large, multicenter Phase III clinical trials of investigational compounds. Emphasis will be placedon the conduct of studies that include patients with varying demographics (age, gender, genetic background and disease state such as renal and hepatic). Issues pertaining to clinical operations, project management, human subjects protections and data safety monitoring will be discussed. An introduction to principles of population pharmacokinetics and pharmacodynamics will be included. The course will include conceptsof post marketing surveillance of approved drugs for drug safety and idiosyncratic reactions, global approaches for pharmacovigilance and compliance with ICH guidelines for recording and dissemination of adverse events. Issues pertainingto pharmacoepidemiology and clinical utilization/effectiveness of the drug will also bediscussed. Pre-Requisite: To take this course you must: Have taken the following Course PHDD8050 min grade C/Pass. |
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| PHDD8080 | Pharmaceutical Economics and Management This course will provide students a background in project management issues in the conduct of global clinical trials, financial aspects of drug development and pharmacoeconomics of approved drug/drug products. The first module will focus on logistic and strategic issues of project management encountered in modern drug development. It includes exposure to principles of project management of complex programs involving: pharmaceutical development, operations, and regulatory affairs. In addition, the corporate challenges involved with portfolio management and optimization will be presented focusing on tools used for optimum decision making. This knowledge base will be applied towards selective case presentations with the goal to identify critical decision points in the process that dramatically impact the successful launch of a new product. The second module will emphasize the business and financial aspects of drug development, including biotechnology and other innovative small pharmaceutical companies that derive their funding primarily from venture capital funding, business strategies, outsourcing and merger and acquisitions. Valuation of the new chemical/molecule as it evolves in the drug development pipeline will be discussed. |
The Clinical Trials Design and Research Graduate Certificate program is designed for individuals working in the scientific, regulatory, and business aspects of drug development.
Pharmacy, medical, nursing, and business graduates already working in drug development will benefit from this online degree program.
Prerequisites
- A U.S. bachelors degree from a regionally accredited college or university or an equivalent degree from a foreign country
- A grade-point average (GPA) of at least 3.00 or foreign equivalent
- Some experience in drug development or clinical research
- For international students, a Test of English as a Foreign Language (TOEFL) of at least 90 (internet-based) or 235 (computer-based), or a Duolingo English Test of at least 110 is accepted.
- GRE is not required for the graduate certificate
Complete the online application and submit the application fee.
Standard Application Fees:
- $65.00 for domestic applicants to most degree programs
- $70.00 for international applicants to most degree programs
- $20.00 for domestic applicants to Graduate Certificates
- $25.00 for international applicants to Graduate Certificates
- Application fees are waived for Summer 2026 applications submitted by March 1st, 2026
- Application fees are waived for Fall 2026 applications submitted by July 1st, 2026
- Fee waivers are automatically applied for applicants who:
- are currently serving in the US armed forces
- are veterans of the US armed forces
All applicants are required to upload unofficial transcripts during the application process, showing all undergraduate and graduate course work completed, including degrees granted and dates of conferral.
Official transcripts are not required until the student has received and accepted an offer of admission from the university. Once the offer has been confirmed, the student must submit official transcripts.
Students who have received degrees from the University of Cincinnati do not need to submit official paper copies of their UC transcripts.
Transcripts can be submitted electronically or by mail. To see if your transcript(s) can be ordered electronically, visit the links below and search for your previous school(s).
- Parchment
- Please select “University of Cincinnati – Main Campus” as the recipient of your transcript.
- National Student Clearinghouse
- Please have your transcript sent directly to admissions@uc.edu.
If you do not see your past school(s) listed on either site, please contact the school(s) directly. Then, mail your sealed, unopened, official transcripts to:
Please mail sealed, unopened, official transcripts to:
University of Cincinnati
Office of Admissions
PO Box 210091
Cincinnati, Ohio 45221-0091
Two letters of reference are required.
References should come from individuals who can attest to your academic and professional skills. Letters of recommendation from family, friends, current students, politicians, or clergy are not accepted.
A professional and current resume.
Provide a few paragraphs on why you plan to pursue this program and how you plan to use this degree in the future.
| Term | Application Deadline | Classes Start |
|---|---|---|
Summer 2026 Fall 2026 Spring 2027 |
April 1, 2026 August 1, 2026 December 1, 2026 |
May 11, 2026 August 24, 2026 January 11, 2027 |
The University of Cincinnati's online course fees differ depending on the program. On average, students will accrue fewer fees than students attending on-campus classes.
The one fee applied across all UC Online programs is the distance learning fee. Students living outside the state of Ohio must also pay an additional “non-resident” fee to enroll in courses at UC Online. This fee is lower than the out-of-state fee for traditional on-campus programs.
To view tuition information and program costs, visit the Online Program Fees page.
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We offer over 130 degrees from undergraduate to doctoral programs. Each program is supported by a team of Enrollment Services Advisors (ESAs) who are here to help answer any questions you have.