SCRI - The Program
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About the course
The course is aimed at graduates who aim to be part of the clinical Industry. The course is designed by the industry experts keeping in mind latest development and multi-fold requirements of clinical Research Industry. The course intends to provide a holistic view of the Clinical Research industry and provide insights into each element which contribute the clinical research requirements. In addition to the specifics of clinical research, the course would also prepare candidates for a career in corporate setting with focus on communication and other skills.
The course will cover all the elements of clinical research and will be blend of classroom courses ( 4 hours a day , 5 days a week for 4months) and 1 month of the job training with exposure.
Course Details:
- Course Name: Post Graduate Diploma in Clinical Research
- MODULE DETAILS
- Introduction to drug discovery and development
- Clinical trial terminologies
- History of clinical research
- Pre-clinical trials
- Definition of clinical trial
- Phases of clinical trials
- Introduction to pharmacology
- Routes of drug administration
- Pharmacodynamics and pharmacokinetics
- Bio-availability and bio-equivalence
- History of clinical research guidelines
- International Conference on Harmonization (ICH)
- Guidelines for Good Clinical Practice
- ICMR Guidelines for human subjects research
- Drug and cosmetic act
- NDCT Rules 2019
- Ethics committee role and responsibilities
- Informed consent documents
- Clinical trial protocol designing and writing
- Informed consent preparation
- Investigator’s Brochure (IB)
- Writing clinical trial report
- Project management – basics
- Project financing
- Conducting clinical trial feasibility
- Selection of an investigator and site
- Clinical trial stakeholders
- Ethics committee and regulatory submissions
- Investigator responsibilities
- Sponsor and monitor’s responsibilities
- Recruitment techniques
- Retention of clinical trial subjects
- Essential documents
- Investigational product – labelling and packaging
- Documentation in clinical trial conduct
- Safety and adverse event reporting
- Project auditing and preparation
- Introduction to CDM and statistics
- CRF designing
- Clinical data entry
- Electronic data capture
- Data validation
- Clinical data coding
- SAE reconciliation
- External data validation and reconciliation
- Data and tests for data analysis
- Maintaining quality in clinical research
- Handling audits and inspections
- Clinical trial management system
- Electronic Trial Master File (eTMF)
- Communication and soft skills
- Presentation skills
- Developing curriculum vitae
- Attending interviews
- Corporate compliance
16 weeks (4 months) of off-line classroom training
4 weeks (1 month) of on-job training
Course highlights
- Course designed by industry experts
- 100% industry trainers
- Daily case studies presentation and discussion
- Assignments on real time industry case studies
- Includes training on soft skills development
- Course Fees – 1.5 lacs
Eligibility:
- Eligibility: Freshers / Experienced candidates can apply
- B Pharm/M pharm
- B.Sc, M.Sc, ( Botany, Microbiology, Zoology, Chemistry, Biochemistry, Life sciences, Biotechnology, and Bioinformatics or similar lifesciences graduates)
- MBBS, BDS, BAMS, BHMS
Selection criteria
- The Selection would be based on an online general aptitude test (MCQ’s)and subjective questions followed by Personal interview. Entrance exams to be conducted on 18th September 2022
- The entrance exam shall be conducted online and shall by remotely proctored.
- Shortlisted candidates will be called for personal round of interview (Personal only, in exceptional cases Virtual)
- Candidates will be selected based on their Merit Rankings
- Selected candidates will be sent joining letters
- This course is completely in offline mode and all candidates will have to relocate to Thane, Mumbai and have to attend classes in person
Important Dates
- Announcement of Examination dates / Pattern: 15th August 2022
- Conduction of online exam: 18th September 2022
- Announcement of results and call letters for interview: 19th September 2022
- Interview: Virtually or Face to face – 20st to 23rd of September 2022
- Deadline for fees: 27th to 30th September
- Course Start date: induction: 3rd October 2022
- Start of classes: 10th October 2022
- SIRO reserves the right to change the dates and is subject to COVID restrictions
Placement Assistance
- 100% Placement Assistance provided in CROs and Pharmaceutical companies
- Interview preparatory sessions
- Resume Building
- Mock Interviews
- Please Note The Course Does Not Gaurantee A Job In Either Siro Or Any Other Group Company. Scri Shall Make All Efforts In Preparing The Candidates For Internviews And Would Be Gettting In Touch With Various Companies For Campus Interviews And Placements.
Testimonials
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Course Details
- 4 months of continuous classroom training, working on Live projects
- 1-month mandatory internship after training provided by SCRI
- SIRO Own CRO live Projects
- World-wide Clinical research Industry based SOP’s training
- Trainers with minimum of 10+ years of experience
