The QualCert Level 7 Postgraduate Diploma in Clinical Research and Drug Development (PgD Clinical Research) is a highly specialised qualification designed for professionals aiming to advance their expertise, broaden their career prospects, and make impactful contributions to the pharmaceutical and healthcare sectors. This programme equips learners with advanced knowledge of clinical research methodologies, ethical standards, regulatory frameworks, and the complete drug development process from concept to market authorisation.
Learners will gain practical and theoretical skills in clinical trial design, data management, pharmacovigilance, and regulatory compliance. The qualification emphasises evidence-based practice, strategic decision-making, and innovation, preparing learners to address complex challenges in clinical research and drug development.
Ideal for professionals seeking Continuing Professional Development (CPD), this diploma enables learners to specialise in areas such as protocol development, risk assessment, and the management of multi-phase clinical trials. It prepares participants for senior-level roles within pharmaceutical companies, research organisations, hospitals, and regulatory bodies.
Centres delivering this qualification must ensure that teaching staff are competent and experienced in clinical research and drug development. They must also provide access to up-to-date resources, industry-relevant materials, and modern facilities to guarantee a high-quality learning experience and learner success.
The PgD Clinical Research and Drug Development empowers learners with the expertise and confidence to contribute to the advancement of safe, effective, and innovative healthcare solutions in a rapidly evolving global market.
Course Contents of QualCert Level 7 Postgraduate Diploma in Clinical Research and Drug Development (PgD Clinical Research):
The QualCert Level 7 Postgraduate Diploma in Clinical Research and Drug Development (PgD Clinical Research), offers 120 Credits, requiring a Total Qualification Time (TQT) of 1200 hours, including 600 Guided Learning Hours (GLH).
| Unit Ref# | Unit Title | Credits | GLH | TQT |
| QC30102- 1 | Principles of Clinical Research and Ethics | 20 | 100 | 200 |
| QC30102-2 | Clinical Trial Design and Methodology | 20 | 100 | 200 |
| QC30102-3 | Drug Development Process and Regulatory Affairs | 20 | 100 | 200 |
| QC30102-4 | Data Management, Biostatistics, and Analysis | 20 | 100 | 200 |
| QC30102-5 | Pharmacovigilance and Safety Monitoring | 20 | 100 | 200 |
| QC30102-6 | Emerging Trends and Innovations in Drug Development | 20 | 100 | 200 |
Entry Requirements for the QualCert Level 7 Postgraduate Diploma in Clinical Research and Drug Development (PgD Clinical Research):
Minimum Age:
- Learners must be at least 21 years old at the time of enrolment.
Educational Background:
- A bachelor’s degree or an equivalent qualification in pharmacy, pharmaceutical sciences, medicine, life sciences, or a related healthcare field.
- Applicants with alternative qualifications or extensive industry experience may be considered on a case-by-case basis.
Professional Experience:
- Relevant professional experience in clinical research, pharmaceuticals, drug development, or healthcare is recommended.
- Experience in clinical trial management, regulatory submissions, or pharmacovigilance will be an advantage.
Language Proficiency:
- LLearners must demonstrate proficiency in English, both written and spoken, to engage effectively with course materials and assessments.
- Non-native English speakers may be required to provide evidence such as IELTS or an equivalent qualification.
Commitment to CPD:
- Applicants should show a strong commitment to lifelong learning and ongoing professional development within clinical research and pharmaceutical sectors.
Access to Required Resources:
- Learners must have reliable internet access, a computer or laptop, and any necessary software for online study and assessments.
- Centres must provide access to updated learning resources, case studies, and clinical research tools to support high-quality learning.
Learning Outcomes for the QualCert Level 7 Postgraduate Diploma in Clinical Research and Drug Development (PgD Clinical Research):
Principles of Clinical Research and Ethics
- Critically evaluate the fundamental principles and methodologies of clinical research.
- Demonstrate a thorough understanding of ethical frameworks, informed consent, and the rights of research participants.
- Analyse global regulatory requirements and ethical standards for clinical investigations.
- Apply ethical decision-making to complex scenarios in clinical trials.
- Assess the role of Institutional Review Boards (IRBs) or Ethics Committees in safeguarding participant welfare.
Clinical Trial Design and Methodology
- Design advanced clinical trial protocols that meet regulatory and scientific standards.
- Apply statistical principles and sampling techniques to optimise study reliability and validity.
- Evaluate risk-based monitoring approaches to ensure efficient and compliant data collection.
- Integrate adaptive trial designs and innovative methodologies to address emerging challenges.
- Critically assess trial feasibility, budgeting, and timelines for operational success.
Drug Development Process and Regulatory Affairs
- Explain the complete drug development process, from discovery through pre-clinical and clinical phases to market approval.
- Evaluate regulatory submission requirements, including Investigational New Drug (IND) and New Drug Applications (NDA).
- Assess global regulatory pathways and harmonisation efforts for drug approvals.
- Apply knowledge of lifecycle management, variations, and post-approval changes.
- Analyse the impact of regulatory changes on drug development strategies.
Data Management, Biostatistics, and Analysis
- Design and manage clinical trial databases to ensure data integrity and security.
- Apply advanced biostatistical techniques to analyse clinical trial outcomes.
- Interpret statistical results to make evidence-based recommendations for regulatory and clinical decisions.
- Evaluate data validation, cleaning, and quality control processes.
- Utilise modern data management tools and software for efficient trial execution.
Pharmacovigilance and Safety Monitoring
- Implement robust pharmacovigilance systems for adverse event detection and reporting.
- Analyse post-marketing surveillance data to ensure ongoing drug safety and efficacy.
- Develop and execute risk management plans to minimise potential harms.
- Evaluate regulatory requirements for pharmacovigilance across multiple jurisdictions.
- Apply best practices in safety signal detection and risk–benefit analysis.
Emerging Trends and Innovations in Drug Development
- Investigate the impact of digital health technologies, artificial intelligence, and big data on clinical research.
- Assess the opportunities and challenges of personalised medicine and precision therapies.
- Evaluate the role of global regulatory harmonisation in accelerating drug approvals.
- Analyse innovative strategies for improving clinical trial efficiency and patient engagement.
- Develop forward-thinking approaches to adapt to future trends and disruptions in drug development.
The QualCert Level 7 Postgraduate Diploma in Clinical Research and Drug Development is designed for learners who aim to excel in the pharmaceutical, biotechnology, and healthcare industries. This qualification supports professionals who wish to advance their careers, broaden their expertise, and make meaningful contributions to clinical research and healthcare innovation.
Pharmacists and Healthcare Professionals
- Practising pharmacists seeking advanced knowledge in clinical research and drug development.
- Healthcare professionals involved in clinical trial management, ethics, and regulatory compliance.
- Individuals responsible for evaluating therapeutic interventions and their impact on patient care.
Clinical Research Associates and Trial Managers
- Professionals managing clinical trials, monitoring protocols, and ensuring compliance with Good Clinical Practice (GCP).
- Individuals aiming to enhance their expertise in clinical data analysis and study coordination.
Researchers and Academics
- Scientists and researchers focusing on drug discovery, translational medicine, or clinical study design.
- Professionals conducting or supervising clinical investigations and wishing to develop advanced analytical skills.
Regulatory Affairs and Quality Assurance Specialists
- Learners involved in regulatory submissions, ethics committee communications, and pharmacovigilance.
- Professionals ensuring that clinical research adheres to international regulatory frameworks.
Future Leaders and Innovators
- Individuals aspiring to leadership or consultancy roles within pharmaceutical organisations, hospitals, or research institutions.
- Learners committed to driving innovation, improving patient outcomes, and shaping the future of healthcare through evidence-based practices.
To ensure the highest quality of education and training, centres offering the QualCert Level 7 Postgraduate Diploma in Clinical Research and Drug Development must meet the following essential requirements. These standards guarantee that learners receive exceptional guidance, resources, and support throughout their studies.
Qualified and Competent Staff
- Centres must employ experienced tutors and assessors with relevant academic and professional qualifications in clinical research, drug development, or related pharmaceutical sciences.
- Staff should possess up-to-date industry knowledge and practical experience to deliver comprehensive and accurate training.
- Continuous professional development (CPD) for teaching staff is essential to maintain current expertise.
Adequate Learning Resources and Facilities
- Centres must provide fully equipped classrooms or virtual learning platforms that meet professional standards.
- Access to modern digital resources, industry publications, and relevant clinical research software or tools must be available for learners.
- Facilities should include secure and well-organised systems for managing learner assessments and records.
Robust Quality Assurance Processes
- Centres should implement internal quality assurance (IQA) procedures to maintain the integrity and consistency of assessments.
- Regular monitoring, evaluation, and feedback processes should be in place to ensure continuous improvement.
- Compliance with data protection and confidentiality standards is mandatory.
Support Services for Learners
- Centres must offer comprehensive academic and administrative support, including guidance on study techniques, research skills, and career progression.
- Clear communication channels should be provided for resolving learner queries promptly and effectively.
Commitment to High-Quality Delivery
- Centres must demonstrate a commitment to excellence in training delivery and learner success.
- They should foster an inclusive and professional learning environment that promotes collaboration, innovation, and achievement.