This document discusses building a partnership between Biosyss and educational institutions to provide training programs in clinical research. It notes that over 500 institutes educate over 1.15 lakh students in biotech annually, but that job opportunities are limited. The training programs aim to increase students' employability in clinical research profiles like R&D, operations, quality, clinical research, finance, and business development. Biosyss and Ziven Consulting will offer certificates in GCP and clinical research to help students enter the industry. Their experienced team will provide quality, affordable training with placement assistance to nurture talent for clinical research careers.

1. Building Mutually Rewarding Partnership
BIOSYSS & Your INSTITUTION

2. BIOTECH, PHARMA & LIFESCIENCES
INDUSTRY IN INDIA
A Prospectus
“Jobs and Opportunities in Biotech”

4. • Over one 1.15 lakh students studying in more than 500
institutes
• The ratio of Job available : students graduating is lower as
compared to IT
Let’s acknowledge the truth
Opportunities are
select and limited

5. What are we doing?
The first question to be asked
What is the employability of our
students?
Which segment of Industry they
want to enter?
Have they gathered sufficient
information about it?

6. Are my students Employable?
Do they have sufficient hands on training?
How many project have they done?
No of papers published
Live Industrial projects?

7. Ask them:
“Which profile of Industry you want to opt for?”

8. Which profile of Industry they want to opt?
 Research & Development (Preclinical):
Discovery Research, Bioinformatics and Animal Sciences
 Operations:
Process/Product Development, Manufacturing and Production and Environmental Health
& Safety
 Quality:
Quality Control, Quality Assurance and Validation
 Clinical Research:
Clinical Research, Regulatory Affairs and Medical Affairs/ Drug Information
 Finance & Administration:
Finance, Administration, Information Systems and Legal Counsel
 Business Development:
 Business Development and Marketing/Sales
 Project Management
 Science /Technical Writer
 Intellectual Property Advisor

9. Get Updated, Stay Ahead!
Track all the scholarships and grants available
Subscribe to mailers, magazines and websites
Get mentorship

10. Training  Recruitment  Consulting

11. We are building India’s largest Bio-Network
We are conducting online recruitments as well
through our career portal

12. Career Opportunities in Clinical Research

13. About The Training Programs

14. To bring a new drug in market it go through the following processes:
1. Drug Discovery Process : Involves the process of Disease Identification to Generation of
Potential Molecule or Lead Candidate
2. Drug Development Process : categorized in of 2 stages
- Pre Clinical Development : Involves laboratory testing on Pharmacology, Pharmacokinetics,
Toxicology of potential drug molecule on animals
- Clinical Development
Drug Discovery and Development Process
Biosyss Ziven Consulting

15. Drug Discovery Process
Ziven Consulting
Identify Disease
Identify Drug Target
High Throughput Screening
Hit Compounds
(compounds having ability to interact with target)
Lead Candidate
(Hit compound with suitable physical, chemical and biological properties)
Identify Structure Activity relationship (SAR’s)
(How does the activity change as structure is systematically alerted)
Identify Pharmacophore
(Structural feature directly responsible for activity)
Optimization
Lead Candidate
Biosyss

16. “Clinical research is a branch of medical science that determines the safety and effectiveness of
medications, devices, diagnostic products and treatment regimens intended for human use”
• These may be used for prevention, treatment, diagnosis or for relief of symptoms in a disease.
• Clinical trials are conducted by Pharmaceuticals and Biotechnological organization , CRO’s , Research/
Academic Institution and Cooperative groups.
Clinical Trials:
“An organized research study conducted on human beings for the purpose of investigating new methods of
diagnosing, detecting, preventing or treating an illness, disease or disorder”
Drug Development Process - Clinical Trials
Ziven ConsultingBiosyss

17. Phases of Clinical Trials
Ziven Consulting
Phases Goals Subjects Time
Phase 0
• Also known as Human Micro-dosing studies
• Gather preliminary data on drug pharmacokinetics
by single sub-therapeutic dose
• To enable go/ no go decision
10- 15
Phase I
• Initial Safety and tolerability(pharmacology)
• Determine safe Dosage Range (MAD, SAD)
• Indentify Side-Effects
• Only about 70 % of the experimental drug passes
Phase I Trial
20 - 100 Days – Few
months
Phase II
• Effectiveness (therapeutic exploratory)
• Dose Response
• Further Evaluation on Safety
• Only about 35 % of the experimental drug passes
Phase I Trial
100 – 300
~ 1 year
Biosyss

18. Phases of Clinical Trials
Ziven Consulting
Phases Goals Subjects Time
Phase III
• Effectiveness ( therapeutic confirmatory)
• Monitor Side-effects
• Compare to Commonly Used Treatments
• Collect information that will allow the drug or treatment
to be used safely
• Only about 25 % of the experimental drug pass Phase III
Trial
1000 – 5000 Several years
Phase IV
• Post – Marketing (therapeutic use)
• Effectiveness in General Population
• Optimizing Drug Use
Patient
population
Sample
Biosyss

19. Following types of organizations can conduct clinical trials process:
• Pharmaceutical Companies
• Biotechnology Companies
• Contract Research Organizations (CRO); Site Management Organizations (SMOs)
• Research/Academic Institutions
Organizations Involved in Clinical Trials Process
Ziven ConsultingBiosyss

20. • Cost – US $ 800 Million approx
• Time – 10 – 14 years
• Quality (100 % compliance to regulatory guidelines)
Factors for Successful Execution of Clinical Trials
Ziven ConsultingBiosyss

21. Conditions that makes India favorable to conduct clinical trails are:
• Large number of Hospitals and Doctors
• Skilled Manpower
• IT- Infrastructure
• High Enrollment rate
• Wide Spectrum of Diseases
• High Patient Population
• Economic Environment
India : A favorable Destination to Conduct Clinical Trials
Ziven ConsultingBiosyss

22. • Today, global clinical research industry is estimated at 52 billion US$ and Indian CR industry is estimated to
be worth US$ 1.8 billion.
• An estimated 2,10,000 individuals in US and over 70,000 individuals in UK are employed in CR Industry.
• Worth of Pharmacovigilance market worldwide was $1859.9 million in 2008 and is estimated to reach
$2252.2 by 2015.
• Top companies conducting clinical trials in India include : Pfizer, Glaxo SmithKline, Aventis, Novartis, Novo
Nordisk, Astra Zenica etc.
• Indian CR Industry is expected to offer 30,000 – 50,000 jobs to healthcare professionals.
Market Potential : Clinical Research and Pharmacovigilance
Ziven ConsultingBiosyss

23. • Ziven Consulting is a full service Clinical Research Consultancy having expertise across multiple phases of
the clinical development process.
• With the team of expertise Ziven offers the consultancy services to the healthcare organizations
(Pharmaceuticals, Biotech and CROs etc.). Ziven is primarily involved in providing:
1. Clinical Research Consultancy
- Operational Assistance
- Functional Office Support
- Regulatory Affairs and Pharmacovigilance
- Medical Writing
2. Manpower Recruitment
3. Clinical Research Training
Introduction : Ziven Consulting
Ziven ConsultingBiosyss

24. With an objective to impart necessary skills in students to enhance their competency level and guiding them
to enter in the specialized industry of clinical research , Biosyss (India) and Ziven have joined hands to meet its
objective via offering their specialized training programs in clinical research
Joining Hands to Nurture Talent
Ziven ConsultingBiosyss

25. BIOSYSS with Ziven is offering the following specialized professional training programs for entry level :
• Professional Certificate in GCP and Clinical Research
Programs Details:
Duration : 6 months (can be completed within 6 months)
Modality : Correspondence/ Distance Learning
Fee : 12,500 Rs. per program
Evaluation : Assignment Based
Practical Training Component – Participants will get an opportunity to develop practical orientation through
mock Hands-on Training Resource Material.
Training Programs in GCP and Clinical Research
Ziven ConsultingBiosyss

26. Clinical Research : Career Growth
Ziven Consulting
Clinical Research – Job Positions Experience Required
Clinical Study Coordinator (CRC), Clinical Trials Assistant
(CTA), Trainee Clinical Research Associate (CRA)
Fresher
Clinical Research Associate (CRA) 1-2 years
Project Manager/ Team Leader 3- 5 years
Manager-Clinical Research > 5 years
Auditors >5 years
Director/ VP 8-10 years
Job prospects after completing “ Professional Certificate in GCP and Clinical Research”
Biosyss

27. With an objective to provide quality GCP and Clinical Research Training, our industry experts have designed
specialized training program to meet the highest expectations:
1. Economical Program Fee: Covers the basic and advance curriculum of clinical research
2. Quality Content: Covers all the content require at the entry and advanced level
3. Placement Assistance: Being a Manpower Consultant in clinical research, we offers an inherent advantage
to the participants
4. Experience: With over 12 years and 300 clinical trails of experience our Experts and Consultants have
trained large number of working as well as students in clinical research
5. Flexibility: Offer added advantage in terms of completion of training and fee payment options.
6. Ease of study: Being distance learning programs interested candidates can study and complete their
training program at their place.
Advantage BIOSYSS & Ziven Consulting
Ziven Consulting
We provide an edge to the training students in terms of Cost, Quality, Duration along-with 100 %
placement assistance
Biosyss

28. We intend to provide 100% placement assistance to all successful participants via following channels:
• Premium Job Plus package for free (cost around 5k approx) which include:
 Resume Development
 Interview Preparation
 Regular job alerts
 Access to the database of relevant Clinical Research Organizations
 Access to the database of relevant Clinical Research Consultancies etc.
• In-house recruitment placement support and recommendations
Placement Assistance
Ziven ConsultingBiosyss

29. Dr. Shriram Inamdar (PGDMLS, PDCR, ACCR and PGD-HA) has over 12 years of extensive experience in clinical
research. He has coordinated, managed and supervised more than 250 (Phase I to IV) global clinical trials
across a wide range of therapeutic areas with special focus on Oncology and Gastroenterology along with
Orthopedics, Cardiology, General Medicine, Psychiatry, Surgery, Dermatology, etc. Many of these being globally
highest recruiting site team and awarded & certified for good quality data by CRO/Sponsor/Auditors.
Dr. Shriram Inamdar has rich experience in Clinical Operations, Business Development and Coordinating
External/Internal Audits. He is instrumental in identifying and developing numerous new investigators sites
for quality clinical research and developing innovative strategies for high patient recruitment.
Program Director
Ziven ConsultingBiosyss

30. Building Mutually Rewarding Partnership
BIOSYSS & Your INSTITUTION