Cliniminds Programs are Certified & Accredited by
Pharmaceutical Society of India
Advanced Post Graduate Diploma in Clinical Research & Pharmacovigilance
/
Advanced Post Graduate Diploma in Clinical Research & Regulatory Affairs in Pharma
& Clinical Research
/
Advanced Post Graduate Diploma in Clinical Research & Clinical Data Management &
Biostatistics + SAS
Why Clinical Research
- Wide Job Horizon
- Attractive Salaries
- Higher Professional Growth
- Global jobs & Training Opportunities
- Higher Job Satisfication
- Need of more than 50,000 trained clinical Research professionals by 2012 (McKinsey)
Why Cliniminds
- Industry recognized course
s
- Practical oriented Classes
- Industry experienced faculties
- Video conferencing sessions
- Campus interviews
Key Employers
- Max Neeman International
- Dabur
- CliniRx
- Ranbaxy
- Excel Life Sciences
- Pfizer
- Acccenture
- TCS
- Wipro
- Clinsys
- Fortis
- Novartis & Many More other Companies…
Clinical Research
Drug discovery & development
Ethical Considerations
Clinical Trial Regualtions
Clinical Trial Planning & Management
Submissions & Approvals
Study Start Up Process
Monitoring Essentials
QA & QC
Special Clinical Trials
Practiacal case scenarios
Role plays
Hands on training
Pharmacovigilance(Option 1)
- Overview of Pharmacovigilance
- MedDRA
- Diagnosis And Management of ADR
- Medical Evaluation of Adverse Events
- Expedited Reporting Requirements
- PSURs
- PV Database & Signal Detection Tools
- Risk assessment management
- Exposure to Pharmacovigilance Softwares
Pharma Regulatory Affairs(option 2)
- Pharma Regulatory Practices
- Import and Export of Drugs
- GMP
- QA and Regulations
- Regulations Governing Clinical Trials
- Drug Policies in India
- Orphan Drugs
- Regulations in Pharmaceutical Devices
- TRIPS and Pharma Industry
- IPR Management
- Patent Application
CDM & Biostat/SAS (Option 3)
- Overview of Data Management
- Study Set Up
- CRF Design Considerations
- Data Entry,Remote Data Entry
- Identifying and Managing Discrepancies
- Medical Coding
- Database Closure
- Electronic Data Capture
- Tracking CRF Data
- Managing Lab Data
- Collecting AE Data
- Creating Reports and Transferring Data
- Enterprise CDM Tools
- Basics of Biostatistics
- Sample Size Calculation
- Statistical Analysis Plan
- Para / Non-Parametric Tests
- Orientation to SAS Softwares
C-55, First Floor, Preet Vihar, Main Vikas Marg, Delhi – 110 092, India
Mobile: +91-9311188671,+91-9311168241,
+91-9311172560
Tel: +91 11 30287800-04 Fax: +91 11 30287802
Email:
info@cliniminds.com
Website:
www.cliniminds.com
Fee for the Program is Rs100,000 including Laptop with online E-Learning SystemThose
who do not need Laptop, fee would be Rs80,000 payable in 2 instalmentsLimited seats
availableAdmissions ongoing