ICTQual AB Level 7 Postgraduate Diploma in Clinical Research and Drug Development (PgD Clinical Research)
The ICTQual AB Level 7 Postgraduate Diploma in Clinical Research and Drug Development (PgD Clinical Research) is designed for professionals seeking advanced knowledge and practical skills in the rapidly evolving field of clinical research. This qualification equips learners with the expertise to manage, design, and analyse clinical trials while understanding the full drug development lifecycle, from discovery to regulatory approval.
With increasing global demand for safe and effective medicines, there is a growing need for skilled professionals who can ensure compliance with ethical, regulatory, and scientific standards in clinical research. This programme provides learners with a comprehensive understanding of clinical trial design, data management, regulatory frameworks, and evidence-based decision-making, preparing them to make a meaningful impact in pharmaceutical, biotechnology, and healthcare organisations.
Learners will gain practical insights into trial methodology, risk management, and patient safety, while also developing the critical thinking and leadership skills required to oversee complex research projects. The curriculum balances theoretical knowledge with applied learning, enabling learners to confidently contribute to research teams, regulatory submissions, and innovative drug development initiatives.
This postgraduate diploma is particularly suited for professionals who wish to enhance their career prospects, expand their knowledge, and strengthen their Continuing Professional Development (CPD). By completing this qualification, learners are empowered to take on senior roles in clinical research, regulatory affairs, pharmaceutical development, and healthcare innovation, positioning themselves as trusted experts in a globally recognised and highly dynamic sector.
Level 7 Postgraduate Diploma in Clinical Research and Drug Development (PgD Clinical Research)
To enrol in ICTQual AB Level 7 Postgraduate Diploma in Clinical Research and Drug Development (PgD Clinical Research), learner must meet the following entry requirements:
This qualification, the ICTQual AB Level 7 Postgraduate Diploma in Clinical Research and Drug Development (PgD Clinical Research), consists of 6 mandatory units.
- Principles of Clinical Research and Trial Design
- Drug Development Process and Regulatory Requirements
- Clinical Data Management and Biostatistics
- Good Clinical Practice (GCP) and Ethical Compliance
- Pharmacovigilance and Risk Management in Clinical Trials
- Research Methods, Innovation, and Evidence-Based Decision Making
Learning Outcomes for the Study Units:
Principles of Clinical Research and Trial Design
- Understand the fundamental principles of clinical research and trial methodology.
- Analyse different clinical trial phases and study designs, including interventional and observational studies.
- Apply trial planning strategies to optimise efficiency, validity, and reliability of research outcomes.
- Evaluate the role of protocol development, participant recruitment, and trial monitoring in successful clinical research.
Drug Development Process and Regulatory Requirements
- Gain knowledge of the complete drug development lifecycle, from discovery to market approval.
- Understand the regulatory frameworks governing pharmaceuticals and biotechnology products globally.
- Analyse submission processes for regulatory approval, including documentation, compliance, and ethical considerations.
- Apply regulatory knowledge to ensure adherence to national and international standards during drug development.
Clinical Data Management and Biostatistics
- Develop proficiency in clinical data collection, management, and analysis techniques.
- Apply statistical methods to interpret clinical trial results and make evidence-based decisions.
- Evaluate data quality, integrity, and regulatory compliance in clinical research studies.
- Use software tools and methodologies for managing large-scale clinical datasets effectively.
Good Clinical Practice (GCP) and Ethical Compliance
- Understand the principles and guidelines of Good Clinical Practice (GCP).
- Apply ethical frameworks to ensure patient safety, informed consent, and data confidentiality.
- Evaluate the role of ethics committees, institutional review boards, and regulatory authorities.
- Demonstrate the ability to manage ethical dilemmas and maintain compliance in clinical research projects.
Pharmacovigilance and Risk Management in Clinical Trials
- Understand pharmacovigilance principles and post-marketing drug safety monitoring.
- Analyse risk management strategies to identify, assess, and mitigate adverse events.
- Apply international guidelines for signal detection, reporting, and benefit-risk assessment.
- Develop frameworks for maintaining patient safety and regulatory compliance throughout trials.
Research Methods, Innovation, and Evidence-Based Decision Making
- Gain advanced knowledge of research methodologies applicable to clinical and pharmaceutical studies.
- Apply quantitative and qualitative research methods to solve complex clinical problems.
- Understand the role of innovation and emerging technologies in clinical research and drug development.
- Critically evaluate evidence to support regulatory submissions, policy decisions, and healthcare outcomes.
The ICTQual AB Level 7 Postgraduate Diploma in Clinical Research and Drug Development equips learners with advanced skills and knowledge that open pathways to senior roles, research leadership, and global consultancy opportunities. This qualification is designed for professionals seeking to enhance their expertise in clinical trials, drug development, and regulatory compliance, while also supporting Continuing Professional Development (CPD) to remain competitive in a rapidly evolving healthcare and pharmaceutical industry.
Academic Progression
- Opportunities exist for further postgraduate specialisations, including advanced clinical trial management, pharmacovigilance, and regulatory science.
- Supports entry into professional development programmes focused on evidence-based research, drug innovation, and global clinical practices.
- Enables learners to contribute to scientific publications, journals, and international conferences, building academic credibility.
Professional Career Pathways
- Senior roles in clinical research, such as clinical research associate, clinical trial manager, or research coordinator.
- Leadership positions in pharmaceutical companies, biotechnology firms, and contract research organisations (CROs).
- Employment opportunities in regulatory affairs, drug safety, pharmacovigilance, and medical affairs teams.
- Roles in hospitals, research institutions, and healthcare organisations focused on trial governance, patient safety, and drug development.
- Opportunities to lead multidisciplinary research teams and oversee global clinical projects.
Consultancy and Industry Opportunities
- Consultancy roles advising pharmaceutical companies on clinical trial design, regulatory compliance, and drug development strategies.
- Advisory positions in global healthcare and biotechnology projects, including risk management and post-marketing surveillance.
- Engagement with regulatory agencies, healthcare authorities, and international policy groups to support evidence-based decision-making.
- Opportunities to provide expert guidance on innovative therapies, digital health solutions, and emerging research technologies.
- Independent consultancy roles in clinical research, trial optimisation, and regulatory strategy.
Continuing Professional Development (CPD)
- Enhances professional credibility by developing advanced clinical research and drug development skills.
- Encourages lifelong learning through engagement with research, innovation, and international best practices.
- Strengthens leadership, analytical, and decision-making skills for senior roles in pharmaceutical and healthcare sectors.
- Provides networking opportunities with professionals, researchers, and regulators globally.
- Supports the ability to influence clinical research policy, improve patient outcomes, and contribute to healthcare innovation.