Diploma in Clinical Research
Course Overview
Clinical Research is a systematic study for new drugs in human subjects to genenate dita for discovering or verifying the Clinical, Pharmacological including Pharmacodynamic and Pharmacokinetic or adverse effects with the objective of determining safety and efficacy of the new drug
Clinical Research is conducted in 4 phases:
Phase 1-Triab
This is the first time the new drug is administered to a small number, around 20-80 healthy informed volunteers under the close supervision of a doctor. The purpose is to determine whether the new compound is tolerated by the patient's body & behaves in the predicted way
Phase 2-Trials
In this phase, the medicne is admistered to a group of approximately 100-300 informed patients to determine its effect it also to check for any unacceptabile side effects.
Phase 3-Trial
In this phase, the group is between 1000 5000, for company to use statistics to analyze the results. If the results are favorabile, the data is presented to the licensing authorities for a commercial license
Phase 4- Thals
This is a surveillance operation phase after the medicine is made available to doctors, who start prescribing t. The effects are monitored on thousands of patients to help identify any unforeseen side effects
The clinical triab market worldwide is worth over USD 26 billion and the industry has employed an estimated 2,10,000 people in the US & OMY 70.000 in the UK, and that form one-third of the total reserch and designet suff. There are more than 2,50,000 positions vacant globally is salaries vary in the region of appradmately USD 40,000 per annum for a Clinical Research Coordinatox A career in Clinical Research offers esculent job opportunities in USA, Europe, Singapore & India
Curriculum
What would you study :
SEMESTER I
Module I: Pharmaceutical Medicine & Drug Therapy
Module II: Pre-Clinical Development |
Module III: Clinical Research Overview
Module IV: Ethics in Clinical research
SEMESTER II
Module 1: Regulations and Schedule Y
Module II: Global Regulations |
Module III: Designing of Clinical Trials
Module IV: Monitoring of Clinical Trials
Eligibility Criteria
Eligibility:
- 10+2 / Graduate or appearing in final year of Graduation in any discipline
Duration:
- 08 Month Online/offline (Hybrid) Part time.
- Course run at Jigyasa University Dehradun
- Selection based on personnel Interview
Career Opportunities
Career Avenues in Clinical Research:
-
Clinical Research Associates:
– Tomonitor clinical trials, ensure compliance with clinical trial protocol, checks clinical sites activities,make on-site visits,CRFs -
Clinical Research Investigators:
– Conduct BA/BE studies, writing /revising SOP, review of protocols, investigators brochures, ICF & CRFS Protocol, CRF & ICF preparations plans and conduct of BA/BEIEC/IRB affairs-GC. -
Study Coordinators:
– Provides safety & protection while collecting Et managing the study data. -
Data Manager/Biostatistician:
– Design, study Et predict the seriousness of disease, seriousness of disease, evaluate new treatment and effectiveness of medication, participate in research design, data collection, choosing & implementing appropriate methodologies, interpreting the results. -
Regulatory Affairs Managers:
– Review. Et registration of documents, evaluation of technical data, liaison with regulatory authorities. -
Clinical Trials Auditors:
– Conducts audits for regulatory function within trial department to assure compliance with GLP/GCP in accordance with established FDA regulations and company policies & standard operating procedure.
Placement
Companies List for Job Opportunities and previous students are placed.
- TCS
- MAX Health Care
- Patanjali
- Quintiles
- HCG
- JSS
- Cipla
- Cognizant
- HCL
Scope and Highlights
A Diploma in Clinical Research opens up exciting opportunities in the rapidly expanding pharmaceutical, biotechnology, and healthcare industries. The course provides essential knowledge in drug development, clinical trial management, regulatory affairs, and ethical guidelines. Graduates can work as Clinical Research Associates (CRAs), Clinical Trial Coordinators, Data Managers, or Regulatory Affairs Executives in hospitals, research organizations (CROs), pharma companies, and international clinical trial teams. The duration typically ranges from 6 months to 1 year and includes both theoretical and practical training. With growing demand for evidence-based healthcare and global clinical trials, the diploma offers excellent career growth and a strong foundation for higher education or certifications in clinical and pharmaceutical sciences.