BEHIND EVERY CURE FOR THE VARIOUS DISEASES THAT PLAGUED A HUMAN BODY, IS A TEAM OF SCIENTISTS AND THEIR TEAM OF SELFLESS CLINICAL RESEARCHERS.
Clinical research is part of the healthcare science that studies the health and illnesses in humans. It determines the effectiveness and safety of medications, devices, diagnostic products and treatment regimens intended for human use.
Clinical research also considers the ethical issues that could arise from their implementation for prevention, treatment, diagnosis or for relieving symptoms of a disease.
The Clinical Research Programmes offered are:
WSQ Specialist Diploma
WSQ Graduate Diploma
It’s the first of its kind in the clinical research industry. Endorsed and validated by the industry. Each diploma equips the students with practical knowledge and competency-based skills to prepare them for a career in the field of Clinical Research.
- WSQ Diploma in Clinical Research: 6 months
- WSQ Specialist Diploma in Clinical Research: 4 months
- WSQ Graduate Diploma in Clinical Research: 4 months
- A minimum of 15 students for the commencement of the course.
- Students will be informed two weeks in advanced before the start of the course.
• To provide trainees with skills and knowledge that will enable them to respond effectively in a rapidly changing health arena that is strongly influenced by healthcare trends and both local, and international legislations.
• To support and challenge trainees’ the development of their skills and knowledge to enable them to either enter the industry and/or for those already in the industry, to upskill themselves in order to be able to perform in their professional practice more effectively.
• To encourage trainees to leverage on their acquired skills and knowledge to adapt to the ever-changing landscape in clinical research. To provide students with the opportunity to critically evaluate and explore the complexities of conducting clinical research in the current healthcare and legislative environment.
WSQ Diploma in Clinical Research:
- Manage documentation in Clinical Research.
- Monitor progress in Clinical Trials.
- Apply principles of pharmacology in clinical research.
- Manage Lab related matters in Clinical Research.
- Apply ethical theories to trial design.
Course Modules & Synopsis
Manage Documentation in Clinical Research
In this module, you will handle documents in the clinical trials settings, perform efficient filing in clinical trial management and ascertain that the report is being handled by regulatory guidelines.
Monitor Progress in Clinical Trials
In this module, you will learn to perform specific tasks in monitoring clinical trials, manage the clinical trial site using a monitoring tool, perform data monitoring in clinical trials, manage the electronic data capture (EDC) and interpret electronic source data in clinical trials.
Apply the Principles of Pharmacology in Clinical Research
In this module, you will recognise the basic pharmacological principles in clinical trials, apply basic pharmacology in clinical trials and monitor the clinical research process to ensure that the correct pharmacological principles are used.
Manage Lab-related Matters in Clinical Research
In this module, you will identify the different laboratory-related matters, interpret Laboratory results in clinical trials, apply principles of toxicity in clinical trials and calculate the correct drug dosage and IV flow rate using given formula.
Apply Ethical Theories to Trial Design
In this module, you will identify and appraise the vital ethical theories that are employed within clinical research critically, determine the fundamental ethical principles that should be adhered to within clinical trial design to assure the safety of patients, verify that the moral laws are followed in clinical trials and document all non-compliance in accordance to organisational procedure.
Use of Biostatistics in Clinical Research
In this module, you will identify and appraise the pertinent literature surrounding biostatistics in clinical trials, discuss the biostatistical approaches applied in the clinical research process, determine if the correct biostatistical method is being used in the clinical research process and document all non-compliance in accordance to organisational procedure.
Interpret Clinical Development & Product Life Cycle in Clinical Research
In this module, you will identify the phases of the product life cycle, describe the relationship between clinical trials and product life cycle, identify the relationship between the product life cycle and the clinical trial and document how clinical trial industry audit the product life cycle.
Application of Clinical Trial in Drug Development Process
In this module, you will identify and appraise the phases of drug development in clinical trials, identify and appraise the stages of clinical development in clinical trials and describe the association between clinical development and drug development.
Apply Good Clinical Practices in Clinical Research
In this module, you will apply international principles of ethical conduct and subject protection, apply proper clinical practices guidelines (International Conference on Harmonisation (ICH), Food and Drug Administration (FDA), Singapore Good Clinical Practice (SG GCP) and European Union (EU) Clinical trials directive), apply European Union – Good Manufacturing Practice (EU-GMP) in Clinical Trials and differentiate FDA Regulations from EU Regulations.
Manage Clinical Research Trials
In this module, you will manage Clinical Trials, manage data management issues, report adverse events, perform drug accountability and track corrective and preventative actions.
Initiate a Clinical Trial
In this module, you will learn to prepare a research proposal in clinical trial management manage contract negotiation for clinical trials and adhere to safety regulations during reporting in a clinical trial.
- Clinical Trials
- Research & Development
- Multi-centre & Global Trials
- Phase I, II, III and IV drug trials
- Pharmaceutical Industries
- Therapeutics, Diagnostics, Theranostics
- Pharmacogenomics and Pharmacokinetics & Pharmacodynamics (PK/PD studies)
- Drug Formulations, Nutrition & Dietetics
- Drug Delivery & Drug Development
- Clinical Trial Hub – Singapore (All Drug Trial regulations are in place)
- Asia will have about 40-45% of Global Drug Trials.
- Clinical Research Associate (CRA) or
- Clinical Research Coordinator
- Clinical Trial Supervisor
- Trial Manager
- Sr Manager / Country Manager
- Asst Director
- Deputy Director
- Director (for example – Asia pacific)
- Global Director…
At least a C6 at GCE O/A Level English or equivalent or Academic IELTS 6.0 and above or equivalent.
Bachelor or equivalent in Life Sciences or relevant fields.
Application Fee (Non-Refundable and non-transferable)
For local students: S$50.00 (before GST)
(For Singaporeans / PRs / Foreigners with valid passes)
For international students#: S$600 (before GST)(For student pass holder)
Fee Protection Scheme***: Subject to prevailing market rate
Medical Insurance Fee****: Subject to prevailing market rate
***The Fee Protection Scheme (FPS) serves to protect students’ paid fees.
****It is compulsory for all local and international students to purchase medical insurance which is valid throughout their course of studies with the CSM Academy International.
Local students (Singaporeans, PRs & Non-student’s Pass holders) may opt-out for this scheme if they can provide the proof of adequate medical insurance coverage in Singapore.
– Payment of fees is in Singapore Dollars
– Payment method only by Cheque/ Nets/ Telegraphic Transfer
Please ask for a copy of our Programme Executives or Recruitment Agents.
The programme is nationally accredited under the Clinical Research Workforce Skills Qualifications (WSQ) framework. Upon completion of the programme, students will be awarded the WSQ Statement of Attainments (SOAs) and WSQ Qualifications under the Clinical Research WSQ framework.
SkillsFuture Credit information:
- You can submit your SkillsFuture claim 60 days before commencement of the programme. According to SkillsFuture SG, this window period is sufficient for individuals to make claims to facilitate earlier programme registration.
- Please inform the Programme Consultant on the usage of SkillsFuture Credit and advise the appropriate amount to be offset against the qualifying programme fees.
- You can then submit the claim via the SkillsFuture Credit Portal for the appropriate amount to be paid to CSM Academy International for your registered programme.
For more information, please visit http://www.skillsfuture.sg/credit