The QualCert Level 6 Diploma in Clinical Research and Drug Development (D Clinical Research) is a specialised qualification designed for professionals aiming to advance their careers, expand their expertise, and strengthen their Continuing Professional Development (CPD) within the pharmaceutical and healthcare industries. This advanced-level diploma equips learners with the knowledge and practical skills required to manage, oversee, and contribute effectively to clinical research projects and drug development processes.
This programme provides comprehensive coverage of essential topics, including clinical trial design, regulatory compliance, ethical considerations, data analysis, and post-marketing surveillance. Learners will gain a deep understanding of the drug development lifecycle, from pre-clinical research through to commercialisation, enabling them to play a pivotal role in bringing safe and effective treatments to market. Emphasis is placed on practical application and evidence-based approaches, ensuring learners are fully prepared to meet the demands of this critical sector.
Centres delivering this qualification must ensure they employ competent and qualified staff with relevant expertise in clinical research and drug development. They are also required to provide sufficient resources, learning materials, and appropriate facilities to maintain a high standard of training and support. These measures guarantee an effective learning environment that supports learner achievement and professional growth.
By completing the QualCert Level 6 Diploma in Clinical Research and Drug Development, learners will be well-positioned for senior or specialist roles in pharmaceutical companies, clinical research organisations, healthcare institutions, or regulatory bodies, making a meaningful impact on global health and innovation.
Course Contents of QualCert Level 6 Diploma in Clinical Research and Drug Development (D Clinical Research):
The QualCert Level 6 Diploma in Clinical Research and Drug Development (D Clinical Research), consists of a structured set of study units designed to provide learners with in-depth and comprehensive knowledge. The qualification includes a total of 1200 Total Qualification Time (TQT), 600 Guided Learning Hours (GLH), and awards 120 credits.
| Unit Ref# | Unit Title | Credits | GLH | TQT |
| QC30070- 1 | Principles of Clinical Research and Trial Design | 20 | 100 | 200 |
| QC30070-2 | Regulatory Compliance and Good Clinical Practice (GCP) | 20 | 100 | 200 |
| QC30070-3 | Drug Development Lifecycle and Approval Processes | 20 | 100 | 200 |
| QC30070-4 | Data Management, Biostatistics, and Clinical Trial Analysis | 20 | 100 | 200 |
| QC30070-5 | Pharmacovigilance, Risk Management, and Post-Marketing Surveillance | 20 | 100 | 200 |
| QC30070-6 | Research Ethics, Innovation, and Emerging Trends in Clinical Research | 20 | 100 | 200 |
Entry Requirements for the QualCert Level 6 Diploma in Clinical Research and Drug Development (D Clinical Research):
Minimum Age
- Learners must be 18 years or older at the time of enrolment.
Educational Background
- A recognised Level 5 qualification in pharmacy, pharmaceutical sciences, biomedical sciences, healthcare management, or a related discipline, or
- An undergraduate degree or equivalent professional qualification in a relevant field.
Experience
- Professional or practical experience in clinical research, drug development, or healthcare-related roles is strongly recommended to enhance applied learning.
Language Proficiency
- Learners must demonstrate English language proficiency, equivalent to CEFR Level B2 or IELTS 5.5 or higher, to engage successfully with course materials and assessments.
Commitment to CPD
- Applicants should show a clear commitment to Continuing Professional Development (CPD) and an active interest in advancing their knowledge in clinical research and pharmaceutical development.
Access to Required Resources
- Learners must have access to a suitable study environment, including a reliable internet connection, essential learning materials, and any relevant software or tools for completing assignments, research, and projects.
These requirements ensure that learners have the academic background, experience, and resources necessary to succeed in the QualCert Level 6 Diploma in Clinical Research and Drug Development and to contribute effectively to the pharmaceutical and healthcare sectors.
Learning Outcomes for QualCert Level 6 Diploma in Clinical Research and Drug Development (D Clinical Research):
Principles of Clinical Research and Trial Design
- Analyse advanced clinical research methodologies and study designs
- Evaluate ethical considerations and informed consent processes in clinical trials
- Apply knowledge of trial phases to develop effective research protocols
- Assess study feasibility, site selection, and participant recruitment strategies
- Implement quality assurance measures to maintain research integrity
Regulatory Compliance and Good Clinical Practice (GCP)
- Interpret international regulations and guidelines governing clinical trials
- Apply Good Clinical Practice (GCP) principles to ensure compliance and participant safety
- Develop strategies for monitoring and reporting regulatory compliance issues
- Evaluate the impact of changing regulations on clinical research operations
- Implement standard operating procedures (SOPs) for regulatory adherence
Drug Development Lifecycle and Approval Processes
- Explain the stages of drug discovery, pre-clinical research, and clinical development
- Evaluate approval pathways for new drugs, generics, and biologics
- Analyse the role of regulatory agencies in the approval process
- Apply knowledge of submission requirements to prepare documentation for drug approval
- Assess challenges and opportunities in global drug development
Data Management, Biostatistics, and Clinical Trial Analysis
- Apply data management principles for accurate and secure handling of clinical trial data
- Use biostatistical methods to analyse clinical research results
- Interpret data to inform evidence-based decisions in drug development
- Evaluate the reliability and validity of clinical trial findings
- Develop comprehensive reports and presentations based on trial data analysis
Pharmacovigilance, Risk Management, and Post-Marketing Surveillance
- Implement pharmacovigilance systems to monitor drug safety and adverse events
- Analyse risk management plans to ensure ongoing product safety and compliance
- Evaluate post-marketing surveillance strategies and their regulatory requirements
- Apply risk assessment tools to identify and mitigate potential safety concerns
- Develop communication strategies for reporting safety issues to stakeholders
Research Ethics, Innovation, and Emerging Trends in Clinical Research
- Evaluate ethical considerations and dilemmas in clinical research decision-making
- Analyse the impact of innovation and emerging technologies on clinical research practices
- Identify global trends shaping the future of clinical trials and drug development
- Apply ethical frameworks to develop solutions for complex research challenges
- Integrate innovative approaches to enhance efficiency and effectiveness in clinical research
The Course is ideal for :
- Professionals working in pharmaceutical companies, clinical research organisations, or healthcare institutions who wish to progress into senior or specialist roles
- Learners aiming to enhance their career prospects in clinical trial management, drug development, or regulatory affairs
- Graduates in pharmacy, biomedical sciences, life sciences, or healthcare looking to develop advanced expertise in clinical research
- Research coordinators, clinical trial associates, or study managers seeking to strengthen their knowledge and leadership skills
- Quality assurance or compliance officers interested in expanding their understanding of Good Clinical Practice (GCP) and regulatory frameworks
- Individuals aspiring to contribute to innovation, ethical practices, and improved outcomes in clinical research and drug development
- Learners committed to Continuing Professional Development (CPD) within the pharmaceutical, healthcare, or life sciences sectors
- Professionals seeking to influence clinical research strategies and support the development of safe, effective medical treatments
- Employ competent and qualified staff with expertise in clinical research, drug development, and assessment practices
- Provide suitable facilities and learning environments that promote effective teaching, assessment, and learner engagement
- Ensure access to up-to-date learning materials, research tools, and industry-standard resources for all learners
- Maintain robust internal quality assurance (IQA) systems to monitor delivery quality, assessment standards, and learner progress
- Offer clear and transparent assessment procedures with guidance to support learners in meeting qualification requirements
- Ensure reliable IT infrastructure and internet connectivity for blended or online delivery where appropriate
- Provide comprehensive learner support services, including academic guidance, career advice, and pastoral care
- Adhere to all relevant health, safety, and safeguarding regulations to protect both learners and staff
- Keep accurate and secure records of learner achievements and assessments for verification and auditing purposes
- Demonstrate a commitment to continuous improvement, regularly reviewing delivery methods, teaching standards, and learner outcomes