Master in Comprehensive Management and Monitoring of Clinical Trials
IMF Smart Education
Key Information
Campus location
Online Spain
Languages
Spanish
Study format
Distance Learning
Duration
24 months
Pace
Full time
Tuition fees
EUR 476 / per year
Application deadline
Request info
Earliest start date
Sep 2024
Scholarships
Explore scholarship opportunities to help fund your studies
Introduction
master in clinical trials, master in clinical analysis, master in clinical trials, master in clinical trial monitoring
Clinical trials are a growing and highly competitive field of research, but employers find it difficult to hire people with the right skills and knowledge. This program has been designed in consultation with employers from academia and the pharmaceutical industry. You will bring the critical thinking and problem-solving skills that employers are looking for in this multidisciplinary and collaborative field.
Clinical trials are essential to discover whether new healthcare interventions improve patient outcomes. This program will provide an excellent foundation in clinical trials and will enhance the knowledge and understanding of those already working in this field. This is a growing area that offers many exciting career opportunities.
Why study at the IMF School of Biotechnology and Technology? Pharmaceutical?
Active experts
From professionals to professionals. Acquire the most in-demand knowledge in the Biotechnology, Biomedicine, Pharmacy and Nutrition Industry
Design your personalized training
Create your customized training itinerary, so that you access the professional market fully prepared, becoming a leader in the sector
innovative tools
Learn in virtual environments to live a unique academic experience with 3D learning tools
Access to practices
You will be able to do internships in prestigious pharmaceutical laboratories thanks to the agreements signed with IMF Smart Education
Practical cases
During your training you will be able to access practical cases that will bring you closer to business reality
Are we prepared to face this future in the field of comprehensive management and monitoring of clinical trials?
The need for rigorous evaluation of healthcare components is increasingly recognized around the world. This master's degree provides students with an understanding of clinical trials that will prepare them to work in this increasingly important field.
It is suitable for those who want to gain a general understanding of clinical trials, those who want to enter the sector, as well as those who have general or specialist experience in clinical trials and intend to expand their role in trial design, management, analysis and reporting. clinics in most countries.
Curriculum
Master designed by a committee of experts made up of doctors and active professionals in the field of Comprehensive Management and Monitoring of Clinical Trials. Their experience guarantees the suitability of the studies and the skills acquired, whether for entering the world of work or for professional improvement in the sector.
This team of experts, in addition to participating in the training program design committee, collaborates in tutoring and teaching the master's sessions.
General fundamentals of clinical development
- Introduction to the development of a medicine.
- Research, development and manufacturing process of products in the research phase.
- Pharmacodynamic and pharmacokinetic aspects. Bioequivalence and pharmacological bioavailability.
- Toxicological aspects: Preclinical Studies.
- Introduction to the dossier of the product in the research phase
Clinical trials and their main protagonists
- Definition, Characteristics and Classification of EECC.
- Promoter Responsibilities.
- Responsibilities of the Clinical Trials Monitor (CRA). Contract Research Companies (CRO).
- Responsibilities of the Research Team. The Data Collection Notebook (CRD).
- The participating subjects. Informed Consent and Study Insurance.
- The Protocol and the Investigator's Manual.
Regulation of clinical trials
- Ethical principles in human research.
- Regulatory environment of the clinical trial - GCP, ICH, Declaration of Helsinki.
- Regulatory environment USA (FDA), Europe (EMA) and National (AEMPS).
- General Data Protection Regulation + e-Health.
Clinical trial management
- Start-up - selection and submission of applications (Ethical Committees and Agencies).
- Recruitment: Essential milestones (researcher meeting, first patient in...).
- Management of medication and samples.
- Economic Aspects of the EC.
- Study management plans.
- Closure of the centers and closure of the study.
- Post-authorization studies.
Particularities of EECC and substudies
- Clinical Trials in Advanced Therapies: Gene Therapy.
- Clinical Trials in Advanced Therapies: Cellular therapy.
- Clinical Trials on Biological Products.
- Clinical Trials on Health Products.
- Substudies; Pharmacokinetics, Biomarkers and Omics.
Monitoring: study visits
- Pre-study visit
- Home Visit
- Onsite visit
- Remote Monitoring (RM)
- Risk Based Monitoring (RBM)
- Closing visit. Documentation development and reporting
- Essential Documents: Study File
Pharmacovigilance
- Guidelines on Pharmacopoeia and Pharmacovigilance: role of CIOMS, ICH, ISPE, ENCePP.
- Regulatory pharmacovigilance: EU perspective.
- Reporting of adverse events and global regulation.
- Signal detection and risk management.
- Post-marketing risk-benefit assessment.
- Pharmacological management in a clinical trial.
Biostatistics and data management
- Principles on data management.
- Data management regulatory guidelines and standard operating procedures.
- Data review and quality control.
- The role of biostatistics.
- Important concepts in biostatistics.
Quality: audits and inspections
- Standard Work Procedures (SOP).
- Audits and Inspections in Clinical Trials (I)
- Audits and Inspections in Clinical Trials (II)
- Frequent findings in Audits and Inspections.
The Master's Final Project (TFM)
The purpose of the Master's Thesis (TFM) is to individually evaluate the advanced knowledge and general skills of the degree acquired by the student through the completion of an original work, project, report or study. For the student, it is also an unbeatable opportunity to apply the knowledge acquired by recreating the environment and conditions of the real work context.
English course
- Basic, Preintermediate, Intermediate or Advanced.
- The student can choose one of the four levels.
Impact and value of Big Data
- Project management standards
- Agile project management
- Regulatory and ethical aspects
- Data governance
Agile methodologies. Scrum
- What is Scrum and how to apply it
- The Scrum Framework
- Self-organized teams
- The role of clients and stakeholders
- Agile product and project management
- Development and continuous integration
- How to evolve towards an agile organization
Career Opportunities
There is a strong job market for clinical research professionals with the increase in research being conducted and limited resources available. Employment in the clinical research profession is expected to see a large increase over the next few years.
With the number of registered clinical trials skyrocketing, along with an uptick in new reporting mechanisms and policies , there is a booming industry with careers in the following types of jobs:
- Clinical Research Associate
- Clinical research coordinator
- Patient recruitment specialist
- Medical Advisor
- Drug Safety Specialist
- CTA
- Clinical Research Regulatory Compliance Professional
Program Outcome
- Design a clinical study that incorporates sample size, placebo response, statistical significance, blinding, bias minimization, randomization, safety management, as well as concepts surrounding multiple analyzes and multiple arms treatment and assessment criteria.
- Understanding ethical issues, informed consent, inclusion and exclusion criteria regarding human protection and privacy, as well as safety as it relates to the drug development process.
- Understand the global clinical operations framework as it relates to Good Clinical Practice, study conduct and management; management of safety profiles and control and handling of products under investigation.
- Identify and explain the specific procedural, financial, documentation, and oversight requirements of PIs, sponsors, staff, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
- Data management as a fundamental role in a clinical trial, including electronic data capture, the importance of information technology in data collection, capture, management, correction and queries.
- Analyze the elements of communication between the center and the sponsor, health authorities and contracted research organizations, as well as understanding the multidisciplinary teamwork skills necessary to conduct a clinical trial.
- Conducting, analyzing and reporting high-quality clinical trials.
- Being able to intervene in clinical trials, as a researcher, member of Ethics Committees, CRA or in research and development teams of the pharmaceutical industry and CROs.
Scholarships and Funding
Admissions
Accreditations
Program Tuition Fee
Ideal Students
Our master's degree in Comprehensive Management and Monitoring of Clinical Trials (MEC) is designed for students who wish to enter the field of healthcare research or who wish to develop their career by expanding their skills and understanding of the design, implementation, management and presentation of clinical trials. clinical trial reports.
This program is suitable for healthcare professionals already working or seeking to specialize in clinical trials. It will complement and extend previous degree training and work experience, giving you the skills and knowledge to lead clinical trials.
It is advisable to have a solid degree-level training in one of the following areas: Medicine, Pharmacy, Health Sciences, Biological Sciences, Biotechnology...
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