The Level 7 Postgraduate Diploma in Clinical Research and Drug Development (PgD Clinical Research) is an advanced qualification designed for professionals seeking to deepen their expertise in clinical research, pharmaceutical development, and drug evaluation. This programme is not intended for fresh entrants; it is specifically tailored for experienced healthcare and pharmaceutical professionals who wish to enhance their career prospects, expand their knowledge, and actively contribute to their Continuing Professional Development (CPD).
Learners on this programme will gain comprehensive knowledge of the clinical research process, including trial design, ethical considerations, regulatory compliance, and data analysis. The course emphasises evidence-based approaches to drug development, equipping learners with the skills to manage clinical trials, evaluate therapeutic interventions, and ensure adherence to international regulatory standards.
Delivered in line with international standards, the programme combines theoretical understanding with practical application. Learners engage with real-world case studies, research projects, and interactive learning activities, enabling them to make informed decisions that positively impact patient safety, trial integrity, and organisational performance.
Centres delivering this qualification are required to uphold the highest standards of teaching. They must employ competent and qualified staff with expertise in clinical research and drug development, while providing learners with access to all necessary materials, resources, and facilities. This ensures a high-quality learning experience, fostering learner success and professional growth.
By completing this Level 7 Postgraduate Diploma, learners position themselves as leaders in clinical research and drug development, equipped to navigate complex research environments, influence strategic decision-making, and contribute effectively to the advancement of healthcare and pharmaceutical innovation.
Course Overview
Qualification Title
LICQual Level 7 Postgraduate Diploma in Clinical Research and Drug Development (PgD Clinical Research)
Total Units
6
Total Credits
120
GLH
600
Qualification #
LICQ2201227
Qualification Specification
To enroll in the Level 7 Postgraduate Diploma in Clinical Research and Drug Development (PgD Clinical Research) , applicants must meet the following criteria:
|
Qualification# |
Unit Title |
Credits |
GLH |
|---|---|---|---|
|
LICQ2201227-1 |
Principles of Clinical Research |
20 |
100 |
|
LICQ2201227-2 |
Clinical Trial Design and Methodology |
20 |
100 |
|
LICQ2201227-3 |
Regulatory Affairs and Compliance in Drug Development |
20 |
100 |
|
LICQ2201227-4 |
Pharmacovigilance and Drug Safety |
20 |
100 |
|
LICQ2201227-5 |
Biostatistics and Data Analysis in Clinical Research |
20 |
100 |
|
LICQ2201227-6 |
Clinical Research Leadership Project |
20 |
100 |
By the end of this course, learners will be able to:
Unit 1: Principles of Clinical Research
Learning Outcomes:
- Critically evaluate the principles and frameworks underpinning clinical research.
- Analyse ethical considerations, regulatory requirements, and governance in clinical studies.
- Apply evidence-based approaches to plan and assess clinical research activities.
- Demonstrate advanced understanding of trial phases, study designs, and research methodologies.
Unit 2: Clinical Trial Design and Methodology
Learning Outcomes:
- Critically assess the design and methodology of clinical trials, including randomisation, blinding, and control strategies.
- Evaluate the selection of appropriate study populations, endpoints, and trial protocols.
- Apply methodological principles to ensure data integrity, reliability, and validity.
- Develop strategies to address challenges and optimise clinical trial outcomes.
Unit 3: Regulatory Affairs and Compliance in Drug Development
Learning Outcomes:
- Analyse national and international regulatory frameworks for drug development and clinical trials.
- Apply compliance strategies to ensure adherence to Good Clinical Practice (GCP) and ethical guidelines.
- Evaluate regulatory submission processes and documentation requirements for approvals.
- Develop approaches to mitigate risks and maintain regulatory compliance throughout drug development.
Unit 4: Pharmacovigilance and Drug Safety
Learning Outcomes:
- Critically assess pharmacovigilance systems and safety reporting standards.
- Monitor and evaluate adverse drug reactions, signal detection, and risk management practices.
- Apply strategies to improve patient safety and ensure regulatory compliance.
- Analyse safety data to support evidence-based decision-making in clinical research.
Unit 5: Biostatistics and Data Analysis in Clinical Research
Learning Outcomes:
- Apply quantitative and qualitative statistical methods to analyse clinical trial data.
- Critically interpret research outcomes to inform evidence-based clinical decisions.
- Evaluate data validity, reliability, and potential sources of bias.
- Develop advanced skills in statistical reporting and data presentation for regulatory submissions.
Unit 6: Clinical Research Leadership Project
Learning Outcomes:
- Design and implement a clinical research project addressing a real-world challenge.
- Demonstrate project management, leadership, and problem-solving skills in clinical research settings.
- Critically evaluate project outcomes using appropriate performance and research indicators.
- Reflect on professional practice and propose evidence-based recommendations for clinical research improvement.
The LICQual Level 7 Postgraduate Diploma in Clinical Research and Drug Development (PgD Clinical Research) is designed for professionals who want to advance their expertise in clinical trials, drug innovation, and regulatory compliance. This internationally recognized postgraduate diploma in clinical research online is ideal for pharmacists, researchers, healthcare managers, and policy makers seeking career growth, specialization, and global accreditation. Whether you are working in hospitals, pharmaceutical industries, government agencies, or academic institutions, this program equips you with the skills to thrive in modern healthcare and drug development environments.
1. Practicing Pharmacists Seeking Clinical Research Expertise
- Pharmacists aiming to move into advanced clinical research roles
- Professionals looking for international recognition through PgD Clinical Research qualification
- Those wanting to strengthen knowledge in drug development and therapeutic innovation
- Pharmacists seeking eligibility for advanced postgraduate pathways
- Individuals aiming to enhance patient‑centered pharmaceutical care with research insights
2. Pharmaceutical Industry Professionals
- Experts working in drug manufacturing, development, and regulatory affairs
- Professionals seeking Level 7 Clinical Research diploma UK accredited credentials
- Those aiming to improve knowledge in clinical trial design and compliance standards
- Industry specialists preparing for leadership positions in pharmaceutical companies
- Individuals wanting to align product strategies with global healthcare regulations
3. Hospital and Clinical Pharmacy Managers
- Hospital pharmacists managing complex therapeutic cases with clinical trial drugs
- Clinical pharmacy leaders working with multidisciplinary healthcare teams
- Professionals seeking postgraduate diploma in clinical research online flexibility
- Those aiming to improve patient safety through evidence‑based therapies
- Managers preparing for strategic leadership roles in healthcare institutions
4. Healthcare Policy Makers and Administrators
- Government officials involved in healthcare planning and regulation
- Policy makers seeking PgD Clinical Research international qualification for credibility
- Administrators aiming to design cost‑effective and compliant healthcare systems
- Professionals responsible for evaluating drug approval and reimbursement policies
- Leaders preparing for strategic roles in healthcare management
5. Academic and Research Professionals
- Lecturers and trainers in pharmacy, medicine, and healthcare education
- Researchers seeking accredited postgraduate diploma in clinical research for academic credibility
- Those aiming to publish studies on drug development and clinical trials
- Educators wanting to align with global accreditation standards
- Academic staff preparing students for advanced clinical research practice
6. International Healthcare Professionals
- Pharmacists outside the UK seeking globally recognized qualifications
- Professionals aiming for international career mobility in clinical research
- Those wanting affordable postgraduate diploma in clinical research and drug development options
- Practitioners seeking flexible online learning opportunities
- Healthcare workers preparing for advanced licensing or accreditation
7. Early‑Career Graduates and Aspiring Specialists
- Recent pharmacy or healthcare graduates seeking specialization in clinical research
- Individuals wanting to fast‑track career success with PgD Clinical Research
- Those aiming to build strong foundations in drug development and trial management
- Graduates preparing for leadership and advanced postgraduate studies
- Professionals seeking mentorship and structured career pathways
To deliver the Level 7 Postgraduate Diploma in Clinical Research and Drug Development effectively, centres must meet the following requirements:
- Accreditation and Recognition: Centres must be accredited by recognised national or international educational authorities and approved to deliver postgraduate-level programmes in clinical research, pharmaceuticals, or healthcare.
- Qualified Academic Staff: Centres should employ competent and experienced teaching staff with expertise in clinical research, drug development, regulatory affairs, and pharmacovigilance at Level 7 or equivalent.
- Learning Resources: Centres must provide access to comprehensive learning materials, including textbooks, regulatory guidelines, research journals, case studies, and digital learning platforms.
- ICT and Online Learning Infrastructure: Reliable internet access, computers or laptops, and secure online platforms are required to facilitate interactive learning, research, and assessments.
- Practical and Research Facilities: Centres must provide facilities for project work, simulations, and research activities relevant to clinical trials and drug development.
- Assessment and Quality Assurance Systems: Centres should maintain robust assessment processes, including formative and summative evaluations, with quality assurance procedures aligned with international standards.
- Learner Support Services: Centres must provide academic guidance, career advice, and access to professional networks to support learner progression and success.
These requirements ensure that centres deliver a high-quality, internationally recognised programme, providing learners with the knowledge, skills, and practical experience needed to excel in clinical research and drug development roles.
Assessment and Verification
All units within this qualification are subject to internal assessment by the approved centre and external verification by LICQual. The qualification follows a criterion-referenced assessment approach, ensuring that learners meet all specified learning outcomes.
To achieve a ‘Pass’ in any unit, learners must provide valid, sufficient, and authentic evidence demonstrating their attainment of all learning outcomes and compliance with the prescribed assessment criteria. The Assessor is responsible for evaluating the evidence and determining whether the learner has successfully met the required standards.
Assessors must maintain a clear and comprehensive audit trail, documenting the basis for their assessment decisions to ensure transparency, consistency, and compliance with quality assurance requirements.
