M.S. in Clinical Investigation and Development
The M.S. in Clinical Investigation and Development is a 36-credit master's degree p...
M.S. in Clinical Investigation and Development
Boston
INTAKE: Jan & Sept
Program Overview
The M.S. in Clinical Investigation and Development is a 36-credit master's degree program, typically completed full-time in two years, though part-time and online options may also be available for some aspects of the curriculum. It provides advanced academic training in the science of standards and the latest approaches to clinical research investigations. The program is specifically developed to prepare graduates for positions in federal or state healthcare agencies, clinical research organizations (CROs), managed-care institutions, hospitals, and other health-related organizations. It is particularly advantageous for those with a PharmD degree but offers significant value to anyone in a field where knowledge of good clinical practice (GCP), regulatory standards, and the safety and efficacy of regulated products (drugs, devices, biologics) is crucial. The curriculum includes a capstone experience and options for a practicum.
STEM-Designated: Yes, the M.S. in Clinical Investigation and Development program at MCPHS University is STEM-designated. This is a significant benefit for international students on an F-1 visa who attend the on-campus delivery of the curriculum, as it allows them to qualify for an additional two years of Optional Practical Training (OPT) for a total of three years of work authorization in the United States after graduation.
Curriculum: The curriculum for the M.S. in Clinical Investigation and Development is rigorous and comprehensive, covering critical aspects of clinical research. Core courses include "Pharmaceutical R&D: From Discovery to Market," "Research Methodology and Development of Protocols and Proposals," "Conducting Clinical Research Studies," "FDA and Regulatory Affairs," "Statistics in Clinical Research," "Laws and Regulations Governing Human Research," and "Health Epidemiology." The program also delves into topics such as ethics, the protection of human research subjects, and pharmacovigilance. A mandatory "Graduate Project in Clinical Research" or a "Capstone" experience (3 credits) allows students to synthesize their learning. Electives offer further specialization in areas like "Law and Health Policy of Drugs and Devices," "International Regulatory Affairs," "Development and Production of Medical Devices," or various topics in pharmaceutical economics and policy, and public health.
Research Focus: The M.S. in Clinical Investigation and Development program at MCPHS places a strong emphasis on the scientific and methodological aspects of clinical research. The curriculum includes dedicated courses on research methodology, protocol design, statistical analysis, and health epidemiology, which are foundational to conducting robust clinical investigations. The program culminates in a graduate project or capstone that often involves research. While not a Ph.D. program with extensive bench-to-bedside research, it trains students to effectively design, conduct, and monitor clinical trials. The focus is on the "science of standards" and applying proven approaches to clinical research, preparing students to contribute to the advancement of healthcare outcomes through evidence-based practices.
Industry Engagement: MCPHS University boasts strong industry engagement, which is integral to the Clinical Investigation and Development program. Located within a vibrant life sciences cluster, the university fosters an environment where students can "work and network with professional directors, actors, and choreographers." This is likely an error from search results for other programs, but the general principle of connecting students with industry is strong at MCPHS. The program's faculty often includes executives with experience in drugs, devices, biologics, healthcare, and policy, providing students with invaluable real-world insights. The curriculum is designed to meet pressing professional needs, and the university actively steers students toward careers in the life sciences industry, highlighting opportunities in R&D, medical affairs, regulatory affairs, and clinical development. Alumni networks also provide substantial connections for career building. The option for a practicum further enhances hands-on industry exposure.
Global Perspective: The M.S. in Clinical Investigation and Development program at MCPHS inherently incorporates a global perspective due to the universal nature of clinical research and drug development. The curriculum includes courses like "International Regulatory Affairs" and "Global Pharmaceutical Policy," which directly address the worldwide aspects of clinical investigation and product regulation. The program's goal to advance the quality of health outcomes "around the world" underscores its global outlook. By training professionals in regulatory standards and good clinical practice, MCPHS prepares graduates to contribute to international clinical trials and global health initiatives, ensuring the safety and efficacy of regulated products for diverse populations worldwide.
Location
Boston
Score
IELTS 7
Tuition Fee
USD 27825
Postgraduate Entry Requirements
Academic Qualifications: Applicants for postgraduate programs typically require a minimum academic achievement of 70% or above in their bachelor's degree.
English Language Proficiency:
- IELTS: Overall band score of 6.5 or 7.0 with a minimum of 6.0 in each component.
- TOEFL: Overall score of 90 or higher.
- PTE: Overall score of 73 or higher.
- DET (Duolingo English Test): Minimum score of 115.
Massachusetts College of Pharmacy and Health Sciences (MCPHS) in the United States offers a variety of scholarship opportunities specifically designed for international students to help make their education more affordable and accessible. These scholarships recognize academic excellence, leadership qualities, and financial need, enabling talented students from around the world to pursue their healthcare education without financial burden.
Merit-Based Scholarships: MCPHS provides merit-based scholarships that reward outstanding academic performance. International students with strong academic records, competitive test scores, and leadership potential may qualify for these scholarships, which can cover a significant portion of tuition fees.
Need-Based Financial Aid: While limited, some need-based scholarships and financial aid options are available to international students who demonstrate financial need. Applicants must provide evidence of their financial status and submit the required documentation during the admission process.
Program-Specific Scholarships: Certain colleges and departments within MCPHS offer specialized scholarships tailored to specific health science programs such as Pharmacy, Nursing, Physician Assistant Studies, and Public Health. These scholarships often prioritize candidates pursuing high-demand healthcare fields.
International Student Scholarship Opportunities: MCPHS frequently offers dedicated international student scholarships aimed at encouraging a diverse student body. These scholarships are competitive and awarded based on academic merit, leadership, and contributions to the community.
External Scholarships and Partnerships: International students at MCPHS are encouraged to explore external scholarship programs and partnerships offered by governments, private foundations, and international organizations. The university’s financial aid office provides guidance and resources to help students identify and apply for these opportunities.
A Master of Science (M.S.) in Clinical Investigation and Development from Massachusetts College of Pharmacy and Health Sciences (MCPHS) equips graduates with specialized knowledge and practical training in the intricacies of clinical research.
Clinical Research Coordinator (CRC): CRCs are vital in managing the day-to-day operations of clinical trials at research sites. They handle patient recruitment, data collection, regulatory documentation, and ensure adherence to study protocols and ethical guidelines.
Clinical Research Associate (CRA): CRAs often work for pharmaceutical companies or Contract Research Organizations (CROs), monitoring clinical trials at various sites to ensure compliance with protocols, GCP, and regulatory requirements. They verify data, review case report forms, and ensure trial integrity.
Regulatory Affairs Specialist: These professionals ensure that new medical products (drugs, devices, biologics) and ongoing clinical trials comply with all national and international regulatory guidelines set by bodies like the FDA. They prepare and submit regulatory documents and advise on compliance issues.
Clinical Data Manager: Clinical data managers are responsible for the collection, cleaning, validation, and management of data generated during clinical trials. They ensure data quality and integrity, which is crucial for accurate analysis and reporting.
Pharmacovigilance Specialist/Officer: These specialists monitor and evaluate the safety of pharmaceutical products once they are on the market. They collect, assess, and report adverse drug reactions, contributing to drug safety surveillance and risk management.
Biostatistician (Entry-Level/Support): While often requiring a specialized degree in biostatistics for advanced roles, an M.S. in Clinical Investigation and Development provides a strong foundation in statistics for clinical research, enabling graduates to support biostatisticians in data analysis and interpretation for clinical trials.
Clinical Project Manager: A more senior role, Clinical Project Managers oversee the planning, execution, and management of entire clinical trials, from study initiation to close-out. They manage budgets, timelines, resources, and cross-functional teams to ensure successful trial completion.
Medical Writer (Clinical Focus): Graduates with strong scientific writing skills can work as medical writers, creating clear, concise, and accurate documents related to clinical research, such as study protocols, clinical study reports, regulatory submissions, and scientific publications.
Quality Assurance/Quality Control Specialist (Clinical Trials): These specialists ensure that clinical trials adhere to standard operating procedures (SOPs), good clinical practices (GCP), and regulatory requirements. They conduct audits and inspections to maintain data quality and compliance.
Health Outcomes Researcher (Entry-Level): Leveraging knowledge of epidemiology and statistics, graduates can contribute to research focusing on the effects of healthcare interventions on patient outcomes and the economic value of new treatments, working in pharmaceutical companies, CROs, or academic research centers.
