Clinical Research Course
Post Graduate Diploma in Clinical Research
More than 350 students already recruited at various organizations.
Clinical trials are systematic investigations in human subjects intended to gather safety and efficacy data of a new drug.
The clinical trials conducted all over the world follow universally accepted guidelines and regulations.
These trials for new drugs are conducted on human subjects or patients only after abundant satisfactory information has been collected on its quality and safety through pre-clinical studies and which have an approval from the required health and ethical authorities.
Post Graduate Diploma in Clinical Research is run by Ruby Hall Clinic Pune, who impart quality education to students looking for a career within the industry.
Designed to turn Life Sciences graduates into well-rounded, thinking individuals who will add value to the companies who hire them.
The course includes a balance of theory and honing of soft skills that will increase your chances of employability.
It is our desire that you enjoy this course; learn from it which will give you a feel of working in a live set up. It is our aim that you will increase the pool of bright, enthusiastic and knowledgeable professionals and make even brighter.
Preparing Future Healthcare Leaders
Course Details (Post Graduate Diploma in Clinical Research)
CLINICAL RESEARCH OPERATIONS
- Introduction to Clinical Research & Drug Development
- Research Methodology and Bio Statistics
- Quality Management and Clinical Trial Documents
- Regulations in Clinical Research
- Ethical Guidelines in Clinical Research
- Career pathways in Clinical Research
- Fundamentals and overview of Pharmacovigilance
- Guidelines – E2A,E2B,E2E
- AE / ADR /SAE Reporting
- PSUR / CIOMS / Med WATCH
- Eudravigilance and Signal Detection
CLINICAL DATA MANAGEMENT
- Introduction and overview of Clinical data Management
- Clinical data Management Systems
- Clinical data Management Guidelines, standards and regulations
- Electronic data capture (EDC)
- Case Report Form
- Data validation and cleaning
Rs. 45,000 + GST -18% (Total =Rs.53,100 /-)
Payment plans: By Cash/Post dated Cheques at the time of Admission.
First Installment - Rs.20, 000/- + GST (Total = Rs.23, 600 /-)
Second Installment - Rs.15, 000/- + GST (Total =Rs.17,700/-)
Third Installment - Rs.10, 000/- + GST (Total =Rs. 11,800/-)
B.Sc/M Sc, B,Pharm,B PTh, Biotech, Nursing Graduates, BAMS, BHMS, BDS, MBBS
- Degree Certificate/Mark Sheet
- ID proof & Two Passport size Photographs
Six Months + One month Internship (Optional)
Clinical Research Operations
Clinical Data Management