Vedic Lifesciences Pvt Ltd

1. Vedic Lifesciences Pvt Ltd
Corporate Overview

2. Vedic Lifesciences Synopsis
vVedic has so far managed over 34 clinical studies (Phase II/ III) and
more than 248 preclinical Studies across multiple therapeutic areas.
ϕCore offerings include Regulatory Submissions & Consulting,
Preclinical Studies, Clinical Project Management (Phase II to IV),
Clinical Data Management, Bio-Statistics and Medical Writing
ϕFounded in 2000, Vedic is a contract research organization that provides
broad-based yet highly tailored drug development & support
services to global Pharma, Biotech and Lifesciences players.
www.vediclifesciences.com

3. Vedic Synopsis
Pre Clinical Pre Clinical
ServicesServices
ConsultingConsulting
Clinical TrialsClinical Trials
(Phase I-IV)(Phase I-IV)
Clinical DataClinical Data
ManagementManagement
BioBio
StatisticsStatistics
Medical Medical
WritingWriting
RegulatoryRegulatory
ConsultancyConsultancy
Other Other
ServicesServices
Feasibility Feasibility
EvaluationEvaluation
Study Study
Protocol & Protocol &
planningplanning
Experimental Experimental
& Project & Project
Management Management
AuditsAudits
GAP analysisGAP analysis
FeasibilityFeasibility
Analytical Analytical
Development Development
& Validation& Validation
Formulation Formulation
DevelopmentDevelopment
Study Study
Feasibility Feasibility
AnalysisAnalysis
Investigator / Investigator /
Site SelectionSite Selection
Regulatory Regulatory
Submission & Submission &
Approval Approval
(IRB/EC & (IRB/EC &
DCGI)DCGI)
Site InitiationSite Initiation
Assessment Assessment
VisitsVisits
Site Site
Management Management
& Monitoring& Monitoring
Investigational Investigational
Product Product
ManagementManagement
CloseoutsCloseouts
Query Query
ResolutionResolution
Data Data
ValidationValidation
Database Database
DesignDesign
Data Entry & Data Entry &
TrackingTracking
Data CodingData Coding
Database Database
Access Access
ManagementManagement
Data Data
Management Management
ReportingReporting
Risk & Query Risk & Query
managementmanagement
Clinical Trial Clinical Trial
DesignDesign
Sample Size Sample Size
CalculationCalculation
Statistical Statistical
Analysis Analysis
PlansPlans
Planning & Planning &
Execution of Execution of
interim interim
analysisanalysis
Final Final
Statistical Statistical
AnalysisAnalysis
Statistical Statistical
Report Report
Study Design/ Study Design/
OutlineOutline
Protocol & its Protocol & its
AmendmentsAmendments
Informed Informed
Consent Consent
DocumentDocument
Patient Diary Patient Diary
and Subject and Subject
Emergency Emergency
CardCard
Clinical / Clinical /
Statistical Statistical
study Reportstudy Report
Publication Publication
SupportSupport
Strategic Strategic
regulatory regulatory
planning for planning for
specific specific
countriescountries
Pre – IND Pre – IND
meetingsmeetings
INDsINDs
NDA and NDA and
ADNAADNA
Applications Applications
for marketing for marketing
license license
SAE SAE
collection, collection,
evaluation, evaluation,
classification classification
& reporting& reporting
Medical case Medical case
reviewsreviews
Adverse event Adverse event
narration & narration &
coding coding
PharmacovigilPharmacovigil
anceance
BA/BE studiesBA/BE studies
Biochemical Biochemical
AssaysAssays
Nutraceutical Nutraceutical
studiesstudies
www.vediclifesciences.com

4. Proficiency in Pre Clinical
www.vediclifesciences.com
7
48
56
60
72
5
0
10
20
30
40
50
60
70
80
FR&D AP RD AMD TOX ONCO
No.Of Studies
FR&D = Formulation
Development
AP = Animal
Pharmacology
RD = Regulatory
Documentation
AMD = Analytical
Method Development
TOX = Toxicity
Studies
ONCO = Oncology

5. Proficiency in Clinical Trials
Number of Trials
5
7
1
1
222
2
7
1
4
Diabetes
Orthopedics
Respiratory Disorder
Lifestyle Diseases
Cardiovascular Diseases
Dermatology
Gastrointestinal
HIV (Phase 0)
Urology/Andrology
Neurology
Others
www.vediclifesciences.com

6. Number of Subjects
340
800
150
60
120
80
110
50
680
60
240
Diabetes
Orthopedics
Respiratory Disorder
Lifestyle Diseases
Cardiovascular Diseases
Dermatology
Gastrointestinal
HIV (Phase 0)
Urology/Andrology
Neurology
Others
No. of subjs
www.vediclifesciences.com
Proficiency in Clinical Trials

7. Number of sites
16
33
9
25252
50
210
Diabetes
Orthopedics
Respiratory Disorder
Lifestyle Diseases
Cardiovascular Diseases
Dermatology
Gastrointestinal
HIV (Phase 0)
Urology/Andrology
Neurology
Others
www.vediclifesciences.com
Proficiency in Clinical Trials

8. Our Investigational Partners
43
26
20
88
46
38
27
40
21
18
22
12
10
15
10
36
0 15 30 45 60 75 90
Oncology
ENT Spe cialist
Gynecologist
Urology/Andrology
Orthopedics
Diabetes
Neurology
Cardiology
RespiratoryInfectious Diseases (AIDS)
Rheumatology
Radiology
Psychology
Gastroenterolo gy
Pediatrics
General P hysician
www.vediclifesciences.com

9. Our reach
www.vediclifesciences.com

10. Our therapeutic focus
OrthopedicsOrthopedics
Enriched experience of 7 trials, Vedic has a pool of more Enriched experience of 7 trials, Vedic has a pool of more
than 46 investigators with more than 1000 patients load. than 46 investigators with more than 1000 patients load.
Vedic has recently completed 2 successful trials.Vedic has recently completed 2 successful trials.
DiabetesDiabetes
Andrology /Andrology /
UrologyUrology
Oncology Oncology
Vedic has proficiency of 5 studies. With company of 38 Vedic has proficiency of 5 studies. With company of 38
investigators with patients load of more than 1300. investigators with patients load of more than 1300.
Enriched experience of 7 trials, Vedic has pool of more 88 Enriched experience of 7 trials, Vedic has pool of more 88
investigators with more than 1500 patients load.investigators with more than 1500 patients load.
vWith advisor Dr. M. Conti, renowned Oncologist from With advisor Dr. M. Conti, renowned Oncologist from
Italy and 5 Pre-clinical projects & 43 clinical Investigator Italy and 5 Pre-clinical projects & 43 clinical Investigator
sites, Vedic can carry out any study.sites, Vedic can carry out any study.
We have recently completed a Disease Surveillance Survey in all We have recently completed a Disease Surveillance Survey in all
Demographics regions of India covering therapeutic areas like Demographics regions of India covering therapeutic areas like
Orthopedics, Diabetes, Anthology /Urology, Oncology, HIV, etc.Orthopedics, Diabetes, Anthology /Urology, Oncology, HIV, etc.

11. Current Projects
Andrology:Andrology:
2 Studies2 Studies Orthopedics: Orthopedics:
1 Study1 Study
BA /BE:BA /BE:
2 Studies2 Studies
Inflammatory: Inflammatory:
1 Study1 Study
Dermatology:Dermatology:
1 Study1 Study
Pre Clinical: Pre Clinical:
6 Studies6 Studies
www.vediclifesciences.com

12. Key Personnel
•Jayesh Chaudhary, Founder & Managing Director, has been involved in pharmaceutical
development and international business since 1994. Jayesh brings in expertise and leadership skills
through the entire drug discovery and development pathway having been involved in several
studies hands-on for scientific design or conduct. Trained in Pharmacy and Microbial Engineering
from University of Minnesota, Jayesh was responsible for the Biocatalyst and Natural Products
technical support and national sales at Boehringer Mannheim India in the early ‘90s.
•Dr. Aliya Shakeel is responsible for Medical Writing & Regulatory Services. Aliya’s experience in Trial
Design and Study Reporting form the basis of Vedic’s Medical Writing department. Her team provides
technical & regulatory support to Sponsors and ensures we are constantly innovating in trial design and
conduct. Aliya is a qualified physician and trained in clinical research & hospital administration.
•Dhirendra V. Singh has a distinguished career of over four years combining outstanding talent in
Clinical Research Project Management, New Business Planning, Risk reduction techniques and
high caliber skills in Business Development. Dhirendra has a formal training of Drug discovery at
Molecular Hematology & Oncology Research Institute, Germany. His familiarity with Clinical
Operations provides a critical support in his role in Business Development at Vedic Lifesciences.
With past experience as Project Coordinator and Project Consultant, he has fair knowledge of
crafting Business & Marketing Plans and Pre-establishment Market Research.
•Dr. Navneet Sonawane heads Clinical Operations, having 10 years of experience in Clinical Research and
practice, which include areas such as Medical Writing, Regulatory Affairs, Project Management & QA. She
has successfully headed Global Clinical Trials in Phase 0 to III across diverse therapeutic areas. During her
tenure at Vedic, she has developed a strong network of GCP trained clinical investigators around India and
her team’s efforts have been appreciated by Sponsors around the globe. She places a high premium on
meeting timelines while ensuring quality.

13. Consultants
•Dr. Mark Miller had a distinguished career as an academic, pharmaceutical industry researcher,
consultant and entrepreneur. His research has made major contributions to numerous fields of
medical research. His recent interests centre on the development of therapeutic agents from South
American ethno-medicines. He reviews grants for numerous international agencies, editorial
reviews for over 40 journals and consults with the World Bank on industry development.
•Dr. Mukesh Kumar leads the Regulatory Affairs Department at Amarex, a USA based CRO. In
addition to regulatory expertise, he has experience as a GLP/GCP auditor and as a trainer in
business processes. Significant appointments of his career include research scientist at the NIH &
Baylor College of Medicine (Houston). Doing research in virology, gene therapy, and molecular
biology, he acquired expertise in biological and combination products.
•Dr. Matteo Conti is currently leading the implementation of a brand new Regional Clinical
Pharmacology Laboratory (RCPL) in Cesena (Italy). He is an Oncologist and obtained his PhD in
Medical Science. While working in IRST, Italy, he was associated with a number of projects and
published in the field of Anticancer Pharmacology. His last book “The Selfish Cell” is considered
to be a summary of his current views in the field of Oncology.
•Dr. Arun Nanivadekar was formerly Medical Director at Pfizer & Wyeth. He has been a member
of Several IRBs/IECs and editorial advisory boards such as the British Medical Journal, Journal of
Association of Physicians of India, and Indian Journal of Pharmacology. Since 1997, he has been
associated with Academy of Clinical Excellence (ACE), Mumbai, Symbiosis Institute of Health
Sciences, and several hospitals. He has been honored with the Lifetime Achievement Award by
Indian Society of Clinical Research in 2008, for his contributions to the field of clinical research.

14. •Dr. Shanta Banerjee is our collaborator and consultant. She is Managing Director of Phytomed
Service Germany. She has achieved her PhD degree in Pharmaceutical Chemistry. She has worked
as postdoctoral Scientist in renowned research laboratories in Europe and America, before starting
her own venture. She has co-author of 30 research publications.
•Dr. Hemant K Singh has been involved in some pioneering work in drug research in India. He
has served as Scientist at the Govt. of India premier drug research center, Central Drug Research
Institute (C.D.R.I.) for last 30 years.
Consultants
•Dr. Krishnan Ramaswamy has an illustrious career in Pharmaceutical product development in
the US Drug Industry. He pursued his masters & PhD from Purdue University. He started his
career in Outcomes Research at Pfizer, as Senior manager. He also worked with Janssen
Pharmaceutical, as Associate Director of Outcomes Research. Currently his responsibilities
include AIDS relief, grant reviews and project management and research with Infinity Foundation
as V.P, R & D.

15. Clinical Research Coordinator (CRCs): Clean & Clinical Research Coordinator (CRCs): Clean &
Quality dataQuality data
Fast Recruitment rateFast Recruitment rate
Source Data Verification 100%Source Data Verification 100%
Start New Sites: Cater all therapeutic areas at higher Start New Sites: Cater all therapeutic areas at higher
rate rate
Provide study feasibility report within 36 hoursProvide study feasibility report within 36 hours
Regulatory AcceptabilityRegulatory Acceptability
Publication Acceptability Publication Acceptability
Our Strength
www.vediclifesciences.com

16. A strategic partner for Clinical Trial ManagementA strategic partner for Clinical Trial Management
Our enriched experience for better timelines and Our enriched experience for better timelines and
qualityquality
Professional approach for organizing your Professional approach for organizing your
innovative research further innovative research further
Clean & Transparent serviceClean & Transparent service
Competitive cost & Reliable ReportsCompetitive cost & Reliable Reports
You can count on us for…
www.vediclifesciences.com

17. Thank You
Kindly visit us
at
www.vediclifesciences.com
Contact Us
at
Jayesh Chaudhary
Managing DirectorManaging Director
[email protected]
Phone: [phone]
(D) [phone]
(M) [phone]