1. Apollo Research & Innovations (ARI)
APGDCR- 1 Year Course Advanced Post Graduate Diploma in Clinical Research

2. Drug Research Introduction
Types of drug innovation :
New molecules (First in class)- New targets through disease pathways analysis
Creates better medicines, explore new indications and make companie market leader
Costly affair, very time consuming and success rate is less
E.g. Drugs for Orphan diseases, Repatha/Praluent (alirocumab) Proprotein convertase subtilisin/kexin type 9 (PCSK9) - >USD1 bn revenue
NCE’s extensions for existing/known target-
Simvastatin (Atorvastatin)
New Formulations- Paclitaxel (Taxol)=>Abraxane (nab-paclitaxel)
Copy/Generics- Atorvastatin (Lipitor)

3. Large Scale manufacturing
Drug & Clinical Research
Drug development stages and activities by stage
Large Scale manufacturing
Phase IV
Drug Discovery
FDA
Review
Pre - Clinical
Clinical Trials
Phase I
20-100
Volunteers
Phase III
Volunteers
IND submitted
NDA submitted
1 FDA approved Drug
10000
compounds
250 Compounds
5 Compounds
Phase II
Volunteers
5 Years
1.5 Years
6 Years
2 Years
2 Years

4. Course Module Class room Internship Placement Assistance
First six months class room training and next 6 months internship
Class room
Internship
Placement Assistance
Corporate level training
Interactive sessions
Power point presentation
Real time
Live trial exposure
Interactions with experts
Infrastructure
Highly skilled personnel
On site exposure to clients
Apollo brand
Interview Q&A sessions
Campus placements
Commencement Date: 17th September 2018
Qualifications-
B.Pharmacy, M.Pharmacy (all branches), Pharm D
B.Sc (Life sciences), M. Sc Biochemistry, Microbiology and Biotechnology
MBBS, BDS, B.P.T, M.P.T, BMMS, BAMS
B.Sc, M.Sc Nursing, B.Tech, M.Tech (Biotech), MS (Pharmaceutical sciences), Pharma M.B.A

5. Course Contents Introduction to clinical research and drug development
Module 1
Ethical guidelines and regulation in clinical research
Module 2
Research methodology and statistics
Module 3
Clinical trial process
Module 4
Quality management and clinical trial documents
Module 5
Clinical trial finance and budgeting
Module 6
Clinical data management
Module 7
Pharmacovigilance
Module 8
Personality Development
Module 9

6. Practical Exposure GCP work shop
CRA feasibility
Site selection visit
Budgeting
Clinical trial agreement review
Site initiation visit
IP receipt and drug accountability
ICF process documentation
Source documentation
Randomization procedures
Paper CRF and eCRF entries, discrepancy resolution
Lab samples handling and processing including PK samples
SAE at site reporting to sponsor and EC
SAE narrative writing
AE/SAE capturing in source notes
CIOMS reporting to EC
Site close out visit
Archival
EC meetings

7. Courses & Contacts Courses Hyderabad -
ADVANCED POST GRADUATE DIPLOMA IN CLINICAL RESEARCH ( APGDCR)
POST GRADUATE DIPLOMA IN CLINICAL RESEARCH ( PGDCR)
ADVANCED PROFESSIONAL COURSE IN CLINICAL RESEARCH ( APCCR)
EXECUTIVE PROGRAM IN PHARMACOVIGILANCE
Hyderabad -
Ms. Chandana Pal | |
New Delhi -
Ms. Sunita Kumari | |
Ahmedabad -
Mr. Alex Peter | |
Chennai -
Mr. Sathyanarayana |

8. Career Our Top Recruiters Drug Safety Associate
Clinical Trial Assistant
Clinical Research Associate
Clinical Research Coordinator
Safety Data Analyst
Global PV Scientist
Regulatory Affairs Assistant
Drug Safety Specialist

9. Thank you!