LICQual Level 6 Diploma in Clinical Research & Drug Development
The discovery of new medicines and therapies is one of the most powerful drivers of progress in healthcare. Every breakthrough treatment begins with rigorous testing, careful monitoring, and a commitment to patient safety. This is where clinical research and drug development play a vital role. Without structured research and development, innovative ideas would never translate into safe, effective treatments that improve lives.
The LICQual Level 6 Diploma in Clinical Research and Drug Development (D Clinical Research) highlights the importance of this discipline in shaping the future of medicine. Clinical research and drug development are not simply about trials and approvals—they are about advancing science, ensuring ethical standards, and delivering therapies that meet global healthcare needs. As new technologies, biologics, and personalized treatments emerge, professionals trained in this field are essential for bridging laboratory discoveries with real‑world patient outcomes. For learners, engaging with this subject is more than academic—it is an opportunity to contribute to groundbreaking innovation, strengthen pharmaceutical standards, and play a pivotal role in advancing healthcare worldwide.
Program Outline
The LICQual Level 6 Diploma in Clinical Research and Drug Development (D Clinical Research) is a structured qualification designed to provide learners with advanced knowledge of pharmaceutical innovation and clinical practice. Comprising 6 specialized units and worth 120 credits, the program introduces learners to areas such as clinical trial design, drug safety monitoring, regulatory frameworks, ethical considerations, biostatistics, and global healthcare policies in clinical research and drug development.
This section explains how the course equips learners with the ability to understand clinical research and drug development, apply evidence‑based approaches, and align with international standards effectively. It highlights the type of learners the program is aimed at, the skills they will gain, and the career pathways available upon completion. Readers will also discover how this internationally recognized qualification opens opportunities in hospitals, pharmaceutical companies, biotechnology firms, and research institutions, making it a valuable credential for anyone aspiring to build a career in clinical research and drug development.
Unit Structure
| Qualification | Unit Title | Credits | GLH |
| LICQ2201195-1 | Introduction to Clinical Research | 20 | 80 |
| LICQ2201195-2 | Clinical Trial Design and Methodology | 20 | 80 |
| LICQ2201195-3 | Regulatory Compliance and Ethics in Clinical Research | 20 | 80 |
| LICQ2201195-4 | Data Management and Statistical Analysis | 20 | 80 |
| LICQ2201195-5 | Pharmacovigilance and Risk Management | 20 | 80 |
| LICQ2201195-6 | Advanced Clinical Research Project | 20 | 80 |
Who Can Benefit
The LICQual Level 6 Diploma in Clinical Research and Drug Development (D Clinical Research) is designed for individuals who want to specialize in pharmaceutical innovation and clinical practice. This program is particularly valuable for those who aim to address challenges such as drug safety, trial efficiency, and compliance with international standards. It helps learners strengthen their expertise, improve employability, and prepare for roles where clinical research and drug development are central to healthcare advancement.
Ideal Learners
- Students aspiring to enter pharmaceutical sciences with a focus on clinical research.
- Entry‑level professionals seeking structured training in clinical research and drug development.
- Pharmacy assistants wanting to expand knowledge of trial monitoring and compliance.
- Community pharmacy staff preparing for responsibilities in drug development.
- Hospital pharmacy technicians aiming to strengthen skills in clinical trial processes.
- Healthcare professionals transitioning into clinical research and drug development roles.
- Career changers interested in pharmaceutical innovation and healthcare improvement.
- Ambitious learners who want to develop practical skills for clinical research and drug development careers.
What You’ll Be Able to Do
Unit 1: Introduction to Clinical Research
By the end of this unit, learners will be able to:
- Explain the principles and objectives of clinical research in drug development
- Analyse the roles and responsibilities of clinical research professionals
- Evaluate different types of clinical studies and their applications
- Apply foundational knowledge to support clinical research activities
Unit 2: Clinical Trial Design and Methodology
By the end of this unit, learners will be able to:
- Demonstrate understanding of clinical trial phases and designs
- Analyse protocol development, randomisation, blinding, and control strategies
- Evaluate trial methodologies to ensure reliability and validity
- Apply trial design principles to plan and conduct clinical studies
Unit 3: Regulatory Compliance and Ethics in Clinical Research
By the end of this unit, learners will be able to:
- Explain national and international regulations governing clinical research
- Evaluate ethical considerations and Good Clinical Practice (GCP) requirements
- Apply informed consent procedures and patient safety protocols
- Ensure compliance with regulatory frameworks during clinical trials
Unit 4: Data Management and Statistical Analysis
By the end of this unit, learners will be able to:
- Demonstrate knowledge of clinical data collection, storage, and management
- Analyse trial data using appropriate statistical methods
- Evaluate the integrity and reliability of research data
- Apply data management and statistical techniques to support evidence-based conclusions
Unit 5: Pharmacovigilance and Risk Management
By the end of this unit, learners will be able to:
- Explain principles of pharmacovigilance and post-marketing surveillance
- Analyse adverse event data and implement risk mitigation strategies
- Evaluate regulatory requirements for safety reporting
- Apply risk management procedures to ensure patient safety and regulatory compliance
Unit 6: Advanced Clinical Research Project
By the end of this unit, learners will be able to:
- Plan and execute an independent clinical research project
- Critically review literature and existing data to support project objectives
- Develop solutions and strategies for clinical trial management challenges
- Present project findings professionally, demonstrating analytical and decision-making skills
